Enhanced Usual Care Group Research Articles

Multiple mediation analysis of a task-shared psychosocial intervention for perinatal anxiety: Exploratory findings from a randomized controlled trial in Pakistan

BackgroundThe “Healthy Mother Healthy Baby” (HMHB) study is a phase three, single-blind randomized clinical trial conducted at Holy Family Hospital (HFH) in association with Rawalpindi Medical University (RMU). We aimed to examine the mediators of a specialized psychosocial approach based on Cognitive Behavioural Therapy principles, targeting pregnant women experiencing anxiety. The HMHB intervention was effective in treating perinatal anxiety symptoms and preventing future depressive episodes. MethodsThe trial randomized participants into two arms: the HMHB intervention or Enhanced Usual Care (EUC), following World Health Organization guidelines. The HMHB intervention comprised strategies to strengthen social support networks, improving mother-baby bonding and strategies to deal with interpersonal conflicts, economic challenges, and societal gender preferences using cognitive and behavioural techniques and culturally resonant illustrations. Participants underwent rigorous data collection at three pivotal timepoints: baseline, third trimester, and 6-weeks postnatal. The primary outcome was anxiety symptom severity scores using the Hospital Anxiety and Depression Scale (HADS) at 6-weeks post-childbirth. Four potential mediators – social support, behavioural activation, perceived stress, and pregnancy experience – were assessed in the third trimester of pregnancy. ResultsA total of 1200 participants were randomized to the HMHB and EUC arms. In the six-week follow-up time point, 379 participants remained in the EUC group, and 387 continued in the HMHB group. Post-intervention, HMHB participants displayed significant improvements in postnatal anxiety and depression scores. Mediation analyses revealed social support and pregnancy hassles as significant mediators of the intervention's effect on postnatal anxiety outcomes, while only social support emerged as a significant mediator for depression outcomes. ConclusionThe HMHB intervention showed promising results in improving anxiety and depression scores among pregnant women. Significant mediation effects suggest the importance of targeting social support and managing pregnancy-related hassles for optimal intervention effectiveness.

Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer

Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence. To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET. This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year. Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team. The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms. Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants. This RCT found that a remote monitoring app with alerts to the patient's care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life. ClinicalTrials.gov Identifier: NCT03592771.

The Michigan Men's Diabetes Project Randomized Clinical Control Trial: A Pilot/Feasibility Study of a Peer-Led Diabetes Self-Management and Support Intervention for Black Men With Type 2 Diabetes.

Black men are disproportionately affected by type 2 diabetes (T2D) and experience higher diabetes-related complications than non-Hispanic White men. To address the complex barriers in diabetes self-management for Black men, we implemented a 3-month peer-led and empowerment-based Diabetes Self-Management Education (DSME) and Support (DSMS) intervention in Metro Detroit. Twenty-five Black men ≥55 years of age with self-reported T2D were randomized to the intervention group (n=12)-10 hr of DSME and 9 hr of DSMS-or enhanced usual care (EUC) group (n=13)-10 hr of DSME. Peer leaders (n = 3) were trained by certified diabetes care and education specialists (CDCESs) to cofacilitate the support sessions. Outcomes (hemoglobin A1c [HbA1c], diabetes self-care activities, and diabetes distress) were assessed preintervention and postintervention. In the intervention and EUC groups, mean HbA1c decreased by 0.20% (p = .52, SD = 0.99) and 0.13% (p = .68), respectively. General diet (p = .03, M change: 1.32, SD = 1.71) and blood glucose monitoring (p < .05, M change: 0.50, SD = 0.74) scores improved among those in the intervention group. General diet scores also improved in the EUC group: mean change: 1.77, p = .08, although changes were not statistically significant. Changes in diabetes distress scores differed based on the number of sessions attended, with a significant decrease in those attending 7 to 12 sessions (n = 7), >50%, (p = .003, M change: -5.71, SD = 3.20). Implementing a peer-led DSMS program for Black men was feasible, adopted, and led to positive changes in outcomes. Scaling up the intervention and assessing sustainability is warranted.

Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals

Rural Black participants need effective intervention to achieve better blood pressure (BP) control. Among Black rural adults with persistently uncontrolled hypertension attending primary care clinics, to determine whether peer coaching (PC), practice facilitation (PF), or both (PCPF) are superior to enhanced usual care (EUC) in improving BP control. A cluster randomized clinical trial was conducted in 69 rural primary care practices across Alabama and North Carolina between September 23, 2016, and September 26, 2019. The participating practices were randomized to 4 groups: PC plus EUC, PF plus EUC, PCPF plus EUC, and EUC alone. The baseline EUC approach included a laptop for each participating practice with hyperlinks to participant education on hypertension, a binder of practice tips, a poster showing an algorithm for stepped care to improve BP, and 25 home BP monitors. The trial was stopped on February 28, 2021, after final data collection. The study included Black participants with persistently uncontrolled hypertension. Data were analyzed from February 28, 2021, to December 13, 2022. Practice facilitators helped practices implement at least 4 quality improvement projects designed to improve BP control throughout 1 year. Peer coaches delivered a structured program via telephone on hypertension self-management throughout 1 year. The primary outcome was the proportion of participants in each trial group with BP values of less than 140/90 mm Hg at 6 months and 12 months. The secondary outcome was a change in the systolic BP of participants at 6 months and 12 months. A total of 69 practices were randomized, and 1209 participants' data were included in the analysis. The mean (SD) age of participants was 58 (12) years, and 748 (62%) were women. In the intention-to-treat analyses, neither intervention alone nor in combination improved BP control or BP levels more than EUC (at 12 months, PF vs EUC odds ratio [OR], 0.94 [95% CI, 0.58-1.52]; PC vs EUC OR, 1.30 [95% CI, 0.83-2.04]; PCPF vs EUC OR, 1.02 [95% CI, 0.64-1.64]). In preplanned subgroup analyses, participants younger than 60 years in the PC and PCPF groups experienced a significant 5 mm Hg greater reduction in systolic BP than participants younger than 60 years in the EUC group at 12 months. Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the trial's participants. The results of this cluster randomized clinical trial demonstrated that neither PC nor PF demonstrated a superior improvement in overall BP control compared with EUC. However, PC led to a significant reduction in systolic BP among younger adults. ClinicalTrials.gov Identifier: NCT02866669.

Effect of a brief psychological intervention for common mental disorders on HIV viral suppression: A non-randomised controlled study of the Friendship Bench in Zimbabwe.

For people living with co-morbid HIV and common mental disorders (CMD), it is not known whether a brief psychological intervention for CMD can improve HIV viral suppression. We conducted a prospective cohort study in eight primary care clinics in Harare, Zimbabwe, enrolling adults with co-morbid HIV and CMD. Six clinics provided the Friendship Bench (FB), a brief psychological intervention for CMD based on problem-solving therapy, delivered by lay counsellors. Two clinics provided enhanced usual care (EUC). The primary outcome was viral non-suppression after six months (viral load ≥400 copies/mL). Data were analysed using a difference-in-difference approach with linear regression of cluster-level proportions, adjusted for baseline viral non-suppression (aDiD). The secondary outcome was presence of CMD measured by the Shona Symptom Questionnaire. In FB clinics, 407/500 (81.4%) participants had viral load results at baseline and endline: 58 (14.3%) had viral non-suppression at baseline and 41 (10.1%) at endline. In EUC clinics, 172/200 (86.0%) had viral load results at baseline and endline: 22 (12.8%) were non-suppressed at baseline and 26 (15.1%) at endline (aDiD = -7.3%; 95%CI 14.7% to -0.01%; p = 0.05). Of the 499 participants virally suppressed at baseline, the FB group had lower prevalence of non-suppression at endline compared to the EUC group (2.9% vs 9.3%; p = 0.002). There was no evidence of a difference in endline viral non-suppression by group among the 80 participants with non-suppression at baseline (53.5% vs 54.6%; p = 0.93). The FB group was less likely to screen positive for CMD at endline than the EUC group (aDiD = -21.6%; 95%CI -36.5% to -6.7%; p = 0.008). People living with co-morbid HIV and CMD may benefit from receiving a low-cost mental health intervention to enhance viral suppression, especially if they are already virally suppressed. Research is needed to understand if additional adherence counselling could further improve viral suppression.

Streamlined Genetic Education and Cascade Testing in Men from Hereditary Breast Ovarian Cancer Families: A Randomized Trial.

When a pathogenic BRCA1 or BRCA2 mutation is identified in a family, cascade genetic testing of family members is recommended since the results may inform screening or treatment decisions in men and women. However, rates of cascade testing are low, and men are considerably less likely than women to pursue cascade testing. To facilitate cascade testing in men, we designed a Web-based genetic education tool that addressed barriers to cascade testing, was individually tailored, delivered proactively, and could be used in lieu of pretest genetic counseling to streamline the cascade testing process. We randomized 63 untested men from hereditary cancer families to Web-based genetic education (WGE) versus enhanced usual care (EUC). WGE participants were provided access to a genetic education website after which they could accept or decline genetic testing or opt for pretest genetic counseling. EUC participants received an informational brochure and a letter informing them of their eligibility for genetic testing and recommending they schedule genetic counseling. The primary outcome was the uptake of genetic testing. Men in the WGE group were more likely to complete genetic counseling and/or genetic testing (43% vs. 12.1%; χ2 [n = 63, df = 1] = 7.77, p = 0.005). WGE participants were also more likely to complete genetic testing compared to men in the EUC group (30% vs. 9.1%; χ2 [n = 63, df = 1] = 4.46, p = 0.03). This preliminary trial suggests that a streamlined approach to genetic testing using proactively delivered genetic education may reduce barriers to cascade testing for at-risk men, leading to increased uptake. These results should be interpreted cautiously given the select sample and high rate of non-response.

Effect of the Children and Young People's Health Partnership model of paediatric integrated care on health service use and child health outcomes: a pragmatic two-arm cluster randomised controlled trial.

Paediatric health systems across high-income countries are facing avoidable adverse outcomes and increasing demands and costs. The aim of this study was to compare the effect of an enhanced usual care model with that of an integrated health-care model that offers local health clinics for general paediatric problems and early intervention and care for children and young people with tracer conditions. In this pragmatic two-arm cluster randomised controlled trial, we compared the Children and Young People's Health Partnership (CYPHP) model of care versus enhanced usual care (EUC) among children registered at general practices in south London, UK. The CYPHP trial intervention was delivered between April 1, 2018, and June 30, 2021, and children younger than 16 years during the intervention period and registered at study practices on June 30, 2021, were included in the analysis. A restricted randomisation (1:1) following a computer-generated sequence was done by a masked independent statistician at the level of general practice cluster, stratified by borough (Lambeth or Southwark). Cluster allocation and data collection were masked, with unmasking of trial statisticians before analysis. The CYPHP model comprised all elements of EUC (electronic decision support, a primary care hotline, health checks, self-management support and health promotion, and resilience building and mental health first aid) plus local child health clinics delivered by paediatricians and general practitioners, and a nurse-led early intervention service for children with tracer conditions (asthma, eczema, and constipation). Primary outcomes were non-elective admissions (NELA; admissions coded as an emergency) among the whole trial population up to June 30, 2021, and paediatric quality of life (Pediatric Quality of Life Inventory [PedsQL]) among participants with tracer conditions at 6 months after recruitment. Secondary outcomes were primary and secondary care use, child mental health, parental wellbeing, standardised symptom scores for asthma, eczema, and constipation, health-care quality, and child absences from school and parent absences from work. The trial was registered on ClinicalTrials.gov, NCT03461848, and is complete. The trial was conducted between April 1, 2018, and Dec 31, 2021. In total, 23 general practice clusters, consisting of 70 practices with 97 970 registered children, were randomised to CYPHP (n=11) or EUC (n=12). We found no effect, at the population level, of CYPHP versus EUC on non-elective admissions during the intervention period (adjusted mean incidence rate ratio [IRR] 1·00 [95% CI 0·91 to 1·10], p=0·99). Among children with tracer conditions, we found no difference in paediatric quality of life (PedsQL score) at 6 months (adjusted mean difference -0·033 [95% CI -0·122 to 0·055], p=0·46). As a secondary outcome, among children with tracer conditions and requiring care, NELA rates at 12 months did not differ between the CYPHP and EUC groups (66·1 per 1000 person-years vs 75·3 per 1000 person-years; adjusted mean IRR 0·87 [0·61-1·22], p=0·42). In children requiring care, a statistically significant improvement was observed in eczema symptoms at 6 months from baseline in the CYPHP group versus the EUC group (adjusted mean difference -1·370 [-2·630 to -0·122], p=0·032). Quality of asthma care significantly improved among children in the CYPHP group compared with children in the EUC group. No significant improvement was seen for all other secondary outcomes. Although the CYPHP trial found a null effect for the primary outcomes, we found clinically important improvements in some secondary outcomes including care quality. Previous research has shown that large-scale system change requires time to observe a potential positive effect. Guy's and St Thomas Charity, the Lambeth and Southwark Clinical Commissioning Groups, and Evelina London Children's Hospital.

Pilot Trial of Streamlined Genetic Education and Traceback Genetic Testing in Prostate Cancer Survivors.

Germline genetic testing is recommended for men with metastatic or high-risk prostate cancer to inform treatment and risk management for other cancers and inform genetic testing in at-risk relatives. However, relatively few patients with prostate cancer undergo genetic testing. Given the low rate of testing and increasing demands on genetic service providers, strategies are needed that reduce barriers to testing while conserving genetic counseling resources. The primary goal of this study was to determine whether a proactive and streamlined "traceback" approach could yield increased genetic testing participation among prostate cancer survivors. We randomized 107 survivors of metastatic and high-risk prostate cancer to streamlined testing (ST) versus enhanced usual care (EUC). ST participants were proactively provided with print genetic education materials and the option to proceed to genetic testing without pre-test genetic counseling. EUC participants were sent a letter from their physician advising them of their eligibility for genetic testing and recommending they schedule genetic counseling. The primary outcome was genetic testing participation. Secondary outcomes were distress, knowledge, decision satisfaction, and regret. In the ST group, 41.5% of participants completed genetic testing compared with 27.8% in the EUC group. After adjusting for education and marital status, the odds of testing were more than twice as high for the ST group as for the EUC group (odds ratio, 2.57; 95% CI, 1.05-6.29). The groups did not differ on any of the psychosocial outcomes at the 3-month follow-up. Proactive outreach paired with streamlined genetic testing delivery may be a safe, effective, and resource-efficient approach to facilitate traceback genetic testing in prostate cancer survivors.

Ambulatory Intensive Care for Medically Complex Patients at a Health Care Clinic for Individuals Experiencing Homelessness

Intensive primary care interventions have been promoted to reduce hospitalization rates and improve health outcomes for medically complex patients, but evidence of their efficacy is limited. To assess the efficacy of a multidisciplinary ambulatory intensive care unit (A-ICU) intervention on health care utilization and patient-reported outcomes. The Streamlined Unified Meaningfully Managed Interdisciplinary Team (SUMMIT) randomized clinical trial used a wait-list control design and was conducted at a health care clinic for patients experiencing homelessness in Portland, Oregon. The first patient was enrolled in August 2016, and the last patient was enrolled in November 2019. Included patients had 1 or more hospitalizations in the prior 6 months and 2 or more chronic medical conditions, substance use disorder, or mental illness. Data analysis was performed between March and May 2021. The A-ICU included a team manager, a pharmacist, a nurse, care coordinators, social workers, and physicians. Activities included comprehensive 90-minute intake, transitional care coordination, and flexible appointments, with reduced panel size. Enhanced usual care (EUC), consisting of team-based primary care with access to community health workers and mental health, addiction treatment, and pharmacy services, served as the comparator. Participants who received EUC joined the A-ICU intervention after 6 months. The main outcome was the difference in rates of hospitalization (primary outcome), emergency department (ED) visits, and primary care physician (PCP) visits per person over 6 months (vs the prior 6 months). Patient-reported outcomes included changes in patient activation, experience, health-related quality of life, and self-rated health at 6 months (vs baseline). We performed an intention-to-treat analysis using a linear mixed-effects model with a random intercept for each patient to examine the association between study group and outcomes. This study randomized 159 participants (mean [SD] age, 54.9 [9.8] years) to the A-ICU SUMMIT intervention (n = 80) or to EUC (n = 79). The majority of participants were men (102 [65.8%]) and most were White (121 [76.1%]). A total of 64 participants (41.0%) reported having unstable housing at baseline. Six-month hospitalizations decreased in both the A-ICU and EUC groups, with no difference between them (mean [SE], -0.6 [0.5] vs -0.9 [0.5]; difference, 0.3 [95% CI, -1.0 to 1.5]). Emergency department use did not differ between groups (mean [SE], -2.0 [1.0] vs 0.9 [1.0] visits per person; difference, -1.1 [95% CI, -3.7 to 1.6]). Primary care physician visits increased in the A-ICU group (mean [SE], 4.2 [1.6] vs -2.0 [1.6] per person; difference, 6.1 [95% CI, 1.8 to 10.4]). Patients in the A-ICU group reported improved social functioning (mean [SE], 4.7 [2.0] vs -1.1 [2.0]; difference, 5.8 [95% CI, 0.3 to 11.2]) and self-rated health (mean [SE], 0.7 [0.3] vs -0.2 [0.3]; difference, 1.0 [95% CI, 0.1 to 1.8]) compared with patients in the EUC group. No differences in patient activation or experience were observed. The A-ICU intervention did not change hospital or ED utilization at 6 months but increased PCP visits and improved patient well-being. Longer-term studies are needed to evaluate whether these observed improvements lead to eventual changes in acute care utilization. ClinicalTrials.gov Identifier: NCT03224858.

543-P: A Peer-Led Diabetes Self-Management Education (DSME) and Support (DSMS) Intervention for Black Men with Type 2 Diabetes—Results of a Three-Month Pilot Randomized Clinical Control Trial

Black men are disproportionately impacted by Type 2 diabetes (T2D) and are more likely to die from diabetes complications than non-Hispanic White men. To address the unique challenges this group faces in diabetes self-management, we implemented a 3-month peer-led and empowerment-based DSME/S intervention in metro-Detroit. Twenty-five Black men ≥55 years of age with self-reported T2D were recruited and randomized to either the intervention group (n=12) − 10 hours of DSME and 9 hours of DSMS, or to an enhanced usual care (EUC) group (n=13) − 10 hours of DSME. Peer leaders (n=3), trained by certified diabetes care and education specialists (CDCES) who used training materials related to Black men with diabetes, led the sessions (mean age: 59.7 years; 100% Black, male, and with at least some college education). Changes in A1C levels, diabetes self-care activities, and diabetes distress levels were assessed at baseline and post-intervention. In the intervention group, the mean A1C at baseline was 7.73%, SD 2.16, and at follow-up, 7.06%, SD 1.39. The EUC group experienced a 0.13% decrease in A1C levels (p = 0.68). Within the intervention group, differences in average diet and blood-glucose testing scores, both measured using the Summary of Diabetes Self-Care Activities (SDSCA) measure, from baseline were statistically significant [(p = 0.03, mean change: 1.32, SD 1.71) and (p &amp;lt; 0.05, mean change: 0.50, SD 0.74), respectively]; EUC group general diet scores were: p = 0.08, mean change: 1.77. Diabetes distress scores among those who attended 1-6 sessions, ≤ 50%, (n=4): p = 0.92, mean change: −0.75, SD 14.06. Of those who attended 7-12 sessions, &amp;gt; 50%, (n=7), the decrease in score was statistically significant: p = 0.003, mean change: −5.71, SD 3.20. Implementing a peer-led DSMS program for Black men was feasible, adopted, and led to positive changes in outcomes. Scaling up the program is warranted to measure sustainability. Disclosure A.Ewen: None. K.A.Kloss: None. R.Nwankwo: None. M.M.Funnell: None. G.Piatt: None. J.M.Hawkins: None. Funding National Institute on Aging (2P30AG024824–16); Blue Cross Blue Shield Foundation of Michigan (003063.MG)

Feasibility of a Community-Based, Online, Peer-Supported Spinal Cord Injury Self-management Intervention: Protocol for a Pilot Wait-Listed Randomized Trial

People with spinal cord injury (SCI) report feeling unprepared to manage their disability upon discharge to the community. This situation is exacerbated when they return to settings where self-management support and resources are sparse, thus increasing the risk of costly secondary conditions and rehospitalizations. These factors make a compelling case for implementing innovative community-based SCI self-management programs that empower and engage individuals with SCI. Using a community-engaged research (CEnR) approach, we developed a peer-supported SCI self-management intervention, known as PHOENIX (Peer-supported Health Outreach, Education, and Information Exchange), which integrates online educational content and support from peer navigators (PNs) through telehealth, to promote health and community participation after SCI. The objective of this pilot study is to evaluate the feasibility and acceptability of PHOENIX and the study design, and to obtain estimates of the variability of relevant outcome measures. We conducted a pilot randomized waitlist-controlled trial (n=30) in collaboration with the South Carolina Spinal Cord Injury Association (SCSCIA), our long-standing community-based nonprofit organization research partner. We recruited 4 PNs through our SCSCIA collaboration using its existing network of trained peer mentors. Our study design supported comparison of the following 2 randomly assigned groups: PHOENIX intervention group and waitlist enhanced usual care (EUC) group. The PHOENIX intervention was administered online by PNs over 16 weeks through scheduled "video visits." The EUC group participated in the study for 16 weeks with usual community services and no navigation, and received 4 monthly newsletters from the SCSCIA on a variety of SCI-relevant topics. At the end of the waitlist period, the waitlist EUC group received the full PHOENIX intervention. Measures of feasibility included PN and participant recruitment and retention, PN workload, protocol adherence, and incidence of technical issues. We conducted qualitative interviews with participants and PNs to evaluate the acceptability of PHOENIX and the study design. Outcome measures, including community participation, quality of life, and the occurrence and subjective impact of medically serious secondary conditions and rehospitalizations, were assessed at baseline after randomization and at subsequent time points to allow between-group comparisons. PN hiring and training were completed in August 2018. Recruitment began in November 2018. A total of 30 participants were recruited across South Carolina, and 28 participants completed follow-up by August 2020. An analysis of the results is being finalized, and the results are expected to be published in 2023. This study will provide valuable information to guide future research seeking to address unmet self-management needs and improve outcomes in individuals with SCI. Feasibility findings of this study will provide evidence from CEnR guided by people with SCI and SCI service providers to inform further development, testing, and dissemination of effective and scalable self-management strategies for people with SCI. RR1-10.2196/42688.

Randomised feasibility trial of a virtual intervention to address infant car seat misuse

BackgroundSerious car seat installation errors occur at high rates in infants and children. These errors significantly increase the risk of child injury in a motor vehicle crash, and few interventions...

Abstract 12443: Predictors of Long-Term Adherence to Exercise in Adults With Heart Failure Enrolled in an Exercise Clinical Trial

Introduction: Exercise is recommended for adults with heart failure (HF), but long-term adherence to exercise is poor. The purpose of this analysis is to determine predictors of long-term adherence to exercise in adults with HF enrolled in a RCT testing effects of a behavioral intervention compared to enhanced usual care (EUC) on long-term adherence to exercise. Hypothesis: Unmodifiable (e.g. gender, race, age) and modifiable (e.g. physical function, self-regulation, attitudes) variables predict long-term adherence to exercise in adults with HF. Methods: All subjects (n=204) in this 2-group RCT received paid access to a fitness center for 18 months. Subjects in the intervention group (n=102) also received weekly coaching for 12 months. Adherence was defined as 120 minutes of moderate-intensity exercise weekly. Logistic regression models to examine predictors by group included baseline variables that significantly related to adherence at 12 or 18 months: gender, BMI, 6-minute walk test distance, attitudes, self-regulation, and health status. Results: The sample was 55% men, 47% non-white, and 71% HF with reduced ejection fraction. Mean age was 60.4 years. In the intervention group, gender predicted adherence at both 12 (B=-1.36, p=.01) and 18 months (B=-2.48, p=.003) with men achieving greater adherence at both time points. In the EUC group, no variables in the final model predicted adherence at 12 months and at 18 months, adherence was predicted by baseline scores on the Physical Activity Self-Regulation Scale (B=.084, p=.007) with higher self-regulation associated with a greater likelihood of adherence. Conclusions: To our knowledge, this is the first study to report predictors of long-term adherence to exercise in adults with HF. Men with HF achieved greater adherence to exercise than women following a behavioral coaching intervention. Future studies are necessary to identify behavioral strategies that will promote long-term adherence to exercise in women with HF. Adults with HF that can self-regulate at baseline adhere better to long-term exercise if given guidance to exercise and paid access to a fitness center. These findings are important as we move toward a precision health approach to improve long-term exercise adherence in adults with HF.

Incorporating a Usual Care Comparator into a Study of Meditation and Music Listening for Older Adults with Subjective Cognitive Decline: A Randomized Feasibility Trial.

Background:Recent studies suggest meditation and music listening (ML) may improve cognitive and psychosocial outcomes in adults with subjective cognitive decline (SCD). However, lack of a usual care group has limited conclusions.Objective:To assess the: 1) feasibility of incorporating an enhanced usual care (EUC) comparator in a trial of Kirtan Kriya meditation (KK) and ML for adults experiencing SCD; and 2) preliminary effects of active treatment (KK/ML) versus an EUC program.Methods:Forty participants with SCD were randomized 1:1:2 to a 12-week KK, ML, or EUC program. KK and ML participants were asked to practice 12 minutes/day; EUC participants were given a comprehensive educational packet regarding healthy aging and strategies for improving/maintaining brain health and asked to record any activities or strategies used. Feasibility was assessed using measures of retention, adherence, treatment expectancies, and participant satisfaction, as well as information from exit questionnaires and daily practice/activity logs. Cognitive functioning, stress, mood, sleep-quality, and health-related quality of life (QOL) were measured pre- and post-intervention using well-validated instruments.Results:Thirty-two participants (80%) completed the 3-month study, with retention highest in the EUC group (p < 0.05). Active treatment participants averaged 6.0±0.4 practice sessions/week, and EUC participants, 7.5±0.6 brain health activities/week. Treatment expectancies were similar across groups. EUC participants indicated high satisfaction with the program and study. Despite limited study power, the active treatment group showed significantly greater gains in subjective memory functioning (ps≤0.025) and nonsignificant improvements in cognitive performance (TMT-B), perceived stress, QOL, and mood (ps≤0.08) compared to the EUC group.Conclusion:Findings of this pilot feasibility trial suggest incorporation of an EUC program is feasible, and that participation in a simple 12-week relaxation program may be helpful for adults with SCD versus engagement in an EUC program.

A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic

BackgroundUp to 75% of hip fracture patients never recover to their pre-fracture functional status. Supervised exercise that includes strength training can improve functional recovery after hip fracture. The role of testosterone replacement for augmenting the effects of exercise in older women after hip fracture is unknown. MethodsThe Starting Testosterone and Exercise after Hip Injury (STEP-HI) Study is a 6-month Phase 3 multicenter randomized placebo-controlled trial designed to compare supervised exercise (EX) plus 1% testosterone topical gel, with EX plus placebo gel, and with enhanced usual care (EUC). Female hip fracture patients age ≥ 65 years are being recruited from clinical centers across the United States. Participants are community dwelling and enrolled within 24 weeks after surgical repair of the fracture. The EX intervention is a center-based program of progressive resistance training. The EUC group receives a home exercise program and health education. Participants receive dietary counseling, calcium and vitamin D. The primary outcome is the Six Minute Walk Distance. Secondary outcomes include physical performance measures, self-reported function and quality of life, and dual energy x-ray absorptiometry measures of body composition and bone mineral density. ResultsEnrollment, interventions, and follow-up are ongoing. We describe the impact of the coronavirus disease 2019 pandemic on the trial, including modifications made to allow continuation of the interventions and outcome data collection using remote video and audio technology. ConclusionsResults from the STEP-HI study are expected to have important clinical and public health implications for management of the growing population of hip fracture patients.

Effect of a Motivational Interviewing–Based Intervention on Initiation of Mental Health Treatment and Mental Health After an Emergency Department Visit Among Suicidal Adolescents

Emergency department (ED) visits present opportunities to identify and refer suicidal youth for outpatient mental health care, although this practice is not routine. To examine whether a motivational interviewing-based intervention increases linkage of adolescents to outpatient mental health services and reduces depression symptoms and suicidal ideation in adolescents seeking emergency care for non-mental health-related concerns who screen positive for suicide risk. In this randomized clinical trial, adolescents aged 12 to 17 years who screened positive on the Ask Suicide Screening Questions (ASQ) during a nonpsychiatric ED visit at 2 academic pediatric EDs in Ohio were recruited from April 2013 to July 2015. Intention-to-treat analyses were performed from September 2018 to October 2019. The Suicidal Teens Accessing Treatment After an Emergency Department Visit (STAT-ED) intervention included motivational interviewing to target family engagement, problem solving, referral assistance, and limited case management. The enhanced usual care (EUC) intervention consisted of brief mental health care consultation and referral. Primary outcomes were mental health treatment initiation and attendance within 2 months of ED discharge and suicidal ideation (assessed by the Suicidal Ideation Questionnaire JR) and depression symptoms (assessed by the Center for Epidemiologic Studies-Depression scale) at 2 and 6 months. Exploratory outcomes included treatment initiation and attendance and suicide attempts at 6 months. A total of 168 participants were randomized and 159 included in the intention-to-treat analyses (mean [SD] age, 15.0 [1.5] years; 126 [79.2%] female; and 80 [50.3%] white). Seventy-nine participants were randomized to receive the STAT-ED intervention and 80 to receive EUC. At 2 months, youth in the STAT-ED group had similar rates of mental health treatment initiation compared with youth in the EUC group as assessed by parent report (29 [50.9%] vs 22 [34.9%]; adjusted odds ratio [OR], 2.08; 95% CI, 0.97-4.45) and administrative data from mental health care agencies (19 [29.7%] vs 11 [19.3%]; adjusted OR, 1.77; 95% CI, 0.76-4.15). At 2 months, youth in the STAT-ED group and the EUC group had similar rates of treatment attendance (1 appointment: 6 [9.7%] vs 2 [3.6%]; adjusted OR, 2.97; 95% CI, 0.56-15.73; ≥2 appointments: 10 [16.1%] vs 7 [12.7%]; adjusted OR, 1.43; 95% CI, 0.50-4.11). There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period. In exploratory analyses, at 6 months, STAT-ED participants had significantly higher rates of agency-reported mental health treatment initiation (adjusted OR, 2.48; 95% CI, 1.16-5.28) and more completed appointments (t99.7 = 2.58; P = .01). This study's findings indicate that no differences were found on any primary outcome by study condition. However, STAT-ED was more efficacious than EUC at increasing mental health treatment initiation and attendance at 6 months. ClinicalTrials.gov identifier: NCT01779414.

Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial

Many women are affected by anxiety and depression after armed conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. WHO through a grant from the Office for Foreign Disaster Assistance.

A Pilot Randomized Controlled Trial of a Telenutrition Weight Loss Intervention in Middle-Aged and Older Men with Multiple Risk Factors for Cardiovascular Disease.

Overweight and obesity threaten the health, functionality and quality of life of 77.2% men in West Virginia. The purpose of this study was to evaluate the feasibility and effectiveness of a 12-week primary care referred telenutrition weight loss intervention. Fifty-nine 40–70-year-old men with obesity were randomized to either the intervention group (n = 29) or an enhanced usual care (EUC) (n = 30) group. Participants from both groups were prescribed a moderate energy restricted diet (500–750 kcal/day below energy requirements) and provided diet-related educational materials; but, only those in the intervention group received weekly support from a registered dietitian nutritionist via telephone and videoconferencing. Both groups significantly reduced body weight, waist circumference, percent body fat and caloric intake and improved diet quality from baseline (p < 0.0001). Groups did not differ after controlling for time (all p > 0.30) and none of the group by time interactions were statistically significant. At week 12, a greater proportion of participants from the intervention group than the EUC group lost at least 5% of their baseline weight, (70.4% vs. 41.4%, p = 0.035). Retention rates and participant-reported adherence and satisfaction rates were ≥80% in the telenutrition group, thereby meeting the a priori criterion for feasibility of a larger trial. Primary care referred telenutrition interventions have the potential to improve access to dietary counseling for obesity treatment in health disparate populations. A larger longer-term trial is warranted.

A Cluster Randomized Controlled Trial of a Stepped-Care Intervention Delivered by Lay Health Workers for Primary Care Patients with Major Depressive Disorder in Nigeria

BACKGROUND: Little is currently known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. METHODS: Cluster randomized trial conducted in thirty-five primary care clinics in Ibadan, Nigeria (18 intervention arm, 17 control arm). Participants were adults, aged 18 or older, not pregnant, and with moderate to severe depression. The intervention arm received 8 sessions of individual problem-solving therapy, with additional sessions if needed (STEP), plus enhanced usual care (EUC). Control arm received EUC alone. Usual care was enhanced by the use of WHO mhGAP intervention guide. Primary outcome, conducted by blinded assessors, was depression remission at 12 months (score =6 on the 9-item Patient Health Questionnaire). Secondary outcomes were depressive symptoms, disability and quality of life at 6 and 12 months. Service utilization and associated costs were measured. Trial registration number is ISRCTN 46754188. FINDINGS: Participants were 1178 (STEP plus EUC: 631; EUC: 547); 82·8% females. Baseline mean PHQ-9 score was 13·7 (±2·6), 87·9% completed 12-month follow-up (STEP plus EUC: 89%; EUC: 86%). At 12-month, remission from depression was 75·6% in the intervention arm and 77·4% in the control arm [adjusted risk difference -1·8% (95% CI: -6·9, 3·4%), adjusted odds ratio 1·0 (95% CI: 0·70, 1·40)]. At 6 months, the STEP plus EUC group had lower mean depression symptoms than EUC group (3·4 vs. 4·3; adjusted difference in means -0·7 (95% CI -1·3 to -0·2)). No differences in other secondary outcomes were evident. INTERPRETATION: Among primary care patients with moderate to severe depression receiving care from non-physician primary health care workers in Nigeria, STEP plus EUC had similar costs and clinical outcomes as EUC alone. Enhancing usual care with mhGAP-IG may provide simple and affordable approach to scaling up depression care in sub-Saharan Africa. Trial Registration Number: ISRCTN 46754188. Funding: Medical Research Council (MRC) Declaration of Interest: The authors declare that they have no competing interests. Ethical Approval: The Study was approved by the UI/UCH Ethics Committee and its conduct monitored by an independent Trial Steering Committee. All participants provided written (or witnessed, if illiterate) informed consent.

Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure

Few exercise training studies in patients with heart failure (HF) report adherence to guideline-recommended 150 minutes of moderate-intensity exercise per week, and no studies have focused on a primary outcome of adherence. This randomized controlled trial evaluated the effect of a multicomponent intervention, Heart Failure Exercise and Resistance Training (HEART) Camp, on adherence to exercise (after 6, 12, and 18 months) compared with an enhanced usual care (EUC) group. Patients (n = 204) were 55.4% male, overall average age was 60.4 years, and 47.5% were nonwhite. The HEART Camp group had significantly greater adherence at 12 (42%) and 18 (35%) months compared with the EUC group (28% and 19%, respectively). No significant difference (P > .05) was found at 6 months. The treatment effect did not differ based on patient's age, race, gender, marital status, type of HF (preserved or reduced ejection fraction) or New York Heart Association functional class. Left ventricular ejection fraction (LVEF) significantly moderated the treatment effect, with greater adherence at higher LVEF. The multicomponent HEART Camp intervention showed efficacy with significant effects at 12 months and 18 months. Adherence levels remained modest, indicating a need for additional research to address methods and strategies to promote adherence to exercise in patients with HF.