Participants In Intervention Arm Research Articles

Protocol of an open, three-arm, individually randomized trial assessing the effect of delivering sexual and reproductive health information to young people (aged 13\u201324) in Kenya and Peru via mobile phones: adolescent/youth reproductive mobile access and delivery initiative for love and life outcomes (ARMADILLO) study stage 2

BackgroundYoung people face special challenges to accessing needed sexual and reproductive health (SRH) information and support. With high penetration and access, mobile phones provide a new channel for reaching young people, but there is little evidence around the impact of digital interventions on improving health outcomes. The Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) study will assess the effect of an intervention providing SRH information to young people via text message on their mobile phones in Kenya and Peru. This protocol details an open, individually-randomized, three-arm trial lasting seven weeks to assess the effect of the ARMADILLO intervention on dispelling myths and misconceptions related to contraception. A secondary objective is to determine whether youth given access to SRH information via text message can accurately retain that information.MethodsFollowing a household enumeration, one eligible youth per household will be randomly selected for participation and randomized by computer into one of the three arms. Intervention arm participants will receive access to ARMADILLO content, control participants will receive no information, and ‘Arm 3’ participant interactions will vary by site: in Kenya, they will be alerted to various SRH domains and encouraged to learn on their own; in Peru, they will receive key content from each domain with the option to learn more if they wish. Participants will complete multiple-choice questionnaires administered by data collectors at baseline (prior to randomization), at intervention-period end (after week seven), and eight weeks after timing out of the intervention period.DiscussionPart of the Sustainable Development Goal commitment towards ensuring healthy lives and promoting well-being for all at all ages includes a commitment to ‘ensuring universal access to sexual health and reproductive health-care services, including for family planning, information and education’. If proven to be effective, interventions like ARMADILLO can bridge an important gap towards achieving universal access to SRH information and education for an otherwise difficult-to-reach group.Trial registrationThis trial was retrospectively registered with the ISRCTN Registry and assigned registration number ISRCTN85156148 on 29 May, 2018.

Digital Health Intervention for Asthma: Patient-Reported Value and Usability.

BackgroundAlthough digital health tools are increasingly recognized as effective in improving clinical outcomes such as asthma control and medication adherence, few studies have assessed patient experiences and perception of value.ObjectiveThe aim of this study was to evaluate patient satisfaction, perception of usability and value, and desire to continue after 12 months of using a digital health intervention to support asthma management.MethodsParticipants were enrolled in a randomized controlled study evaluating the impact of a digital health platform for asthma management. Participants used electronic inhaler sensors to track medication use and accessed their information in a digital health platform. Electronic surveys were administered to intervention arm participants aged 12 years and older after 12 months of use. The survey assessed asthma control, patient satisfaction with the sensor device, and perception of the usability and value of the digital health platform through closed-ended and open-ended questions. Logistic regression models were used to assess the impact of participants’ characteristics on survey completion, satisfaction, and perception of value.ResultsOf the 207 intervention arm participants aged 12 years and older, 89 submitted survey responses (42.9% response rate). Of these 89 participants, 70 reported being very satisfied (79%, 70/89) or somewhat satisfied (20%, 18/89) with the inhaler sensor device. Moreover, 93% (83/89) expressed satisfaction with the reports, and 90% (80/89) found the information from the reports useful for learning about their asthma. In addition, 72% (64/89) of the participants reported that they were interested in continuing to use the sensor and platform beyond the study. There were no significant differences in satisfaction with the device or the platform across participants’ characteristics, including device type, age, sex, insurance type, asthma control, or syncing history; however, participants with smartphones and longer participation were more likely to take the survey.ConclusionsElectronic sensors and a digital health platform were well received by participants who reported satisfaction and perceived value. These results were consistent across multiple participants’ characteristics. These findings can add to a limited literature to keep improving digital health interventions and ensure the meaningful and enduring impact on patient outcomes.

The melanoma genomics managing your risk study: A protocol for a randomized controlled trial evaluating the impact of personal genomic risk information on skin cancer prevention behaviors

BackgroundReducing ultraviolet radiation (UV) exposure and improving early detection may reduce melanoma incidence, mortality and health system costs. This study aims to evaluate the efficacy and cost-effectiveness of providing information on personal genomic risk of melanoma in reducing UV exposure at 12 months, according to low and high traditional risk. MethodsIn this randomized controlled trial, participants (target sample = 892) will be recruited from the general population, and randomized (1:1 ratio, intervention versus control). Intervention arm participants provide a saliva sample, receive personalized melanoma genomic risk information, a genetic counselor phone call, and an educational booklet on melanoma prevention. Control arm participants receive only the educational booklet. Eligible participants are aged 18–69 years, have European ancestry and no personal history of melanoma. All participants will complete a questionnaire and wear a UV dosimeter to objectively measure their sun exposure at baseline, 1- and 12-month time-points, except 1-month UV dosimetry will be limited to ~250 participants. The primary outcome is total daily Standard Erythemal Doses at 12 months. Secondary outcomes include objectively measured UV exposure for specific time periods (e.g. midday hours), self-reported sun protection and skin-examination behaviors, psycho-social outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the intervention costs and outcomes. DiscussionThis trial will inform the clinical and personal utility of introducing genomic testing into the health system for melanoma prevention and early detection at a population-level.Trial registration.Australian New Zealand Clinical Trials Registry ACTRN12617000691347.

A mHealth-based care model for improving hypertension control in stroke survivors: Pilot RCT

PurposeHypertension (HTN) is significantly under-treated in stroke survivors.We examined usability and efficacy of a mHealth -based care model for improving post-stroke HTN control (Funding: AHRQ R21HS021794). MethodsWe used a RCT design. Planned study duration was 90 days. Intervention arm (IA) participants measured their BP daily using a smart phone and wireless BP monitor. This was transmitted automatically to the study database. Investigators (Physician + PharmD) made bi-weekly medication adjustments to achieve the BP goal. Control arm (CA) participants received a digital BP monitor and usual care. We examined Usability (measured with Marshfield System Usability Survey) and HTN control efficacy using an ITT (intent-to-treat) and as-treated (AT) analyses. ResultsFifty participants (IA = 28; CA = 22) completed the study. The Marshfield survey question, “I thought the system was easy to use” mean score was 4.6, (5 = strongly agree). Mean SBP declined significantly between enrollment and study completion in the IA. In ITT, IA SBP declined 9.88 mm, p = 0.005. In AT, IA SBP declined 10.81 mm, p = 0.0036. CA SBP decline was 5–6 mm Hg (not significant). In the ITT, baseline HTN control (SBP < 140 mm Hg) was 50% in IA and CA. At study completion, HTN was controlled in 82% (23/28) of IA and 64% (14/22) of CA (p = 0.14). In the AT, HTN was controlled in 89% (23/26) of IA and 58% (14/24) of CA, (p = 0.015). ConclusionA mHealth-based HTN care model had excellent usability and provided better HTN control than usual care in stroke survivors.Clinical Trial.gov: NCT01875094

Tranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial

BackgroundRadical cystectomy for bladder cancer is associated with a high risk of needing red blood cell transfusion. Tranexamic acid reduces blood loss during cardiac and orthopedic surgery, but no study has yet evaluated tranexamic acid use during cystectomy.MethodsA randomized, double-blind (surgeon-, anesthesiologist-, patient-, data-monitor-blinded), placebo-controlled trial of tranexamic acid during cystectomy was initiated in June 2013. Prior to incision, the intervention arm participants receive a 10 mg/kg loading dose of intravenously administered tranexamic acid, followed by a 5 mg/kg/h maintenance infusion. In the control arm, the patient receives an identical volume of normal saline that is indistinguishable from the intervention. The primary outcome is any blood transfusion from the start of surgery up to 30 days post operative. There are no strict criteria to mandate the transfusion of blood products. The decision to transfuse is entirely at the discretion of the treating physicians who are blinded to patient allocation. Physicians are allowed to utilize all resources to make transfusion decisions, including serum hemoglobin concentration and vital signs. To date, 147 patients of a planned 354 have been randomized to the study.DiscussionThis protocol reviews pertinent data relating to blood transfusion during radical cystectomy, highlighting the need to identify methods for reducing blood loss and preventing transfusion in patients receiving radical cystectomy. It explains the clinical rationale for using tranexamic acid to reduce blood loss during cystectomy, and outlines the study methods of our ongoing randomized controlled trial.Trial registrationsCanadian Institute for Health Research (CIHR) Protocol: MOP-342559; ClinicalTrials.gov, ID: NCT01869413. Registered on 5 June 2013.

Why it Worked: Participants' Insights into an mHealth Antiretroviral Therapy Adherence Intervention in China.

Background:Few Antiretroviral Therapy (ART) adherence trials investigate the reasons for intervention success or failure among HIV-positive individuals.Objectives:To conduct qualitative research to explore the reasons for effectiveness of a 6-month mHealth (mobile health) trial that improved adherence among ART patients in China. The intervention utilized Wireless Pill Containers (WPCs) to provide, real-time SMS reminders, WPC-generated adherence reports, and report-informed counseling.Methods:We conducted in-depth interviews with 20 intervention-arm participants immediately following the trial. Sampling was purposeful to ensure inclusion of participants with varied adherence histories. Questions covered adherence barriers and facilitators, and intervention experiences. We analyzed data in nVivo using a thematic approach.Results:Of participants, 14 (70%) were male; 7 (35%) had used injectable drugs. Pre-intervention, 11 were optimal adherers and 9 were suboptimal adherers, using a 95% threshold. In the final intervention month, all but 3 (85%) attained optimal adherence. Participants identified a range of adherence barriers and facilitators, and described various mechanisms for intervention success. Optimal adherers at baseline were motivated by positive adherence reports at monthly clinic visits-similar to receiving A+ grades. For suboptimal adherers, reminders facilitated the establishment of adherence-promoting routines; data-guided counseling helped identify strategies to overcome specific barriers.Conclusion:Different behavioral mechanisms appear to explain the success of an mHealth adherence intervention among patients with varying adherence histories. Positive reinforcement was effective for optimal adherers, while struggling patients benefitted from reminders and data-informed counseling. These findings are relevant for the design and scalability of mHealth interventions and warrant further investigation.

Prostate 8 study: A pilot randomized controlled trial (RCT) of a web-based lifestyle intervention versus control group among men with prostate cancer.

105 Background: Lifestyle behaviors may reduce risk of prostate cancer progression. Guidelines and tools to support lifestyle modification are needed to improve prostate cancer care. Methods: We conducted a 12-week RCT among 73 men with clinical stage T1-T3a prostate cancer to determine if a lifestyle intervention that included a responsive website, Fitbits, and text messaging helps men adopt 8 healthy lifestyle behaviors (vigorous activity, not smoking, and 6 diet factors) compared to a control group. Eligible men had no contra-indications to aerobic exercise, Internet access, and engaged in ≤4 of the targeted 8 habits at baseline. We explored the efficacy of the intervention (n = 32) vs. control (n = 32) on behavior change via a lifestyle survey, 7 days of ActiGraph GT3X+ accelerometer data, and the Prostate 8 (P8) score (8 self-reported behaviors assigned 0 or 1 point, range 0-8). Results: Baseline characteristics were similar between arms. The median baseline P8 score was 3 in each arm. 12-week assessments were 88% complete (intervention, 94%; control, 82%). Intervention arm participants’ wore their Fitbits a median of 82 days (98%, IQR: 72-83), replied to a median of 71% of texts (N = 60, IQR: 57-89%), and visited the website a median of 3 days [IQR: 2-5] and over 3 visits [IQR: 2-5]. Baseline moderate and vigorous activity were self-reported as 3.7 hrs/wk and 12 min/wk (intervention) and 5.3 hrs/wk and 18 min/wk (control). 1 person was a smoker at baseline. Median [IQR] absolute change in the P8 score from baseline to 12 wks was 2.0 [1.0, 3.0] (intervention) and 0.0 [-1.0, 1.0] (control) (p = 0.0005); and the change between groups was statistically significant for cooked tomatoes, cruciferous vegetables, fish, processed meat, but not significant for healthy sources of vegetable fat (high at baseline) or vigorous activity. Accelerometer data indicated no significant differences in change in physical activity between arms. Conclusions: This novel intervention was feasible and acceptable. These data suggest that the intervention was effective for promoting healthier dietary changes; further research is warranted to examine how to facilitate improvements in physical activity. Clinical trial information: NCT02470936.

Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders

ABSTRACTObjective: To assess the feasibility of a mobile health, inhaled corticosteroid(ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Methods: Children aged 2–13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Results: Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Conclusions: Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.Trial registration: ClinicalTrials.gov identifier: NCT02615743.

A Provider-Focused Intervention to Promote Optimal Care of Pediatric Patients With Suspected Elbow Fracture.

Emergency department (ED) and urgent care (UC) physicians' accurate assessment of the neurovascular and musculoskeletal (NV/MSK) examination in pediatric patients with suspected elbow fracture is crucial to the early recognition of neurovascular compromise. Our objective was to determine the impact of computer-based simulation (CBS) and computerized clinical decision support systems (CCDSS) on ED and UC physicians' assessment of the NV/MSK examination of pediatric patients with elbow fracture as noted in their documentation. All ED UC physician participants received CBS training about management of pediatric patients with suspected elbow fracture. Participants were then randomized to receive CCDSS (intervention arm) when an eligible patient was seen or no further intervention (comparison arm.) Participants received feedback on the proportion of patients with discharge diagnosis of elbow fracturewith proper examination elements documented. Twenty-eight ED and UC physicians were enrolled - 14 in each arm. Over the span of 16 weeks, 50 patients with a discharge diagnosis of elbow fracture were seen - 25 in each arm. Twenty-two of 25 (88%) patients seen by intervention arm participants had a complete NV/MSK examination documented. Six of 25 (24%) patients seen by comparison arm participants had a complete NV/MSK examination documented. Elements most commonly missed in the comparison arm included documentation of ulnar pulse as well as radial, median, and ulnar nerve motor functions. Compared with single CBS training alone, repeated exposure to CCDSS after CBS training resulted in improved documentation of the NV/MSK status of pediatric patients with elbow fracture.

Protocol for Moving On: a randomized controlled trial to increase outcome expectations and exercise among breast cancer survivors.

AimThe aim of this study was to test the feasibility and fidelity of an intervention, Moving On, aimed to increase outcome expectations OEs (i.e. what one expects to obtain or avoid as a result of a behaviour) and exercise among breast cancer survivors.DesignRandomized controlled trialMethodsIntervention arm participants will be given a theory‐guided booklet that was co‐created by the research team and three physically active breast cancer survivors who exercise to manage late and long‐term treatment effects. Attention control arm participants will be given a similar booklet focused on diet. Participants will have 1 week to complete reading, writing and reflecting activities in the booklets. Study outcomes will be measured through online surveys; exercise will also be measured objectively with a Fitbit®. Four weeks postintervention, participants’ thoughts about the usefulness, strengths and weakness of the intervention booklet will be assessed. OEs and exercise will be measured at baseline, 4‐, 8‐ and 12‐week postintervention.

Long-term effects of sit-stand workstations on workplace sitting: A natural experiment

ObjectiveSit-stand workstations may result in significant reductions in workplace sitting. However, few studies have examined long-term maintenance under real-world conditions. The purpose of this study was to evaluate workplace sitting time, cardio-metabolic biomarkers, and work productivity during a workplace re-design which included the installation of sit-stand workstations. DesignNatural experiment with appropriately matched comparison. MethodsOffice workers from distinct worksites in the same unit were recruited (Intervention, n=24; Comparison, n=12). Intervention arm participants received a sit-stand workstation and 4 months of sitting-specific motivational support. The comparison arm received 4 months of ergonomic focused motivational support. Time spent in sitting, standing, and other physical activity were measured by activPAL3c for a week. Cardio-metabolic biomarkers and work productivity were also measured. Assessments occurred at baseline, 4 months, and 18 months. ResultsAt 4 months, work sitting time was reduced by 56.7±89.1min/8h workday (d=−0.64), relative to comparison. Standing time (37.4±69.2min/8h workday; d=0.54) and sit-to-stand transitions (3.3±0.4min/8h workday, d=0.44) were also improved relative to comparison. At 18 months, work sitting time reductions (52.6±68.3min/8h workday; d=−0.77) and standing time improvements (17.7±54.8min/8h workday, d=0.32) were maintained in the intervention group relative to comparison. Cardio-metabolic and work productivity changes were mixed; however, strongest effects favoring the intervention group were observed at 18 months. ConclusionsSit-stand workstations, accompanied with behavioral support, were effective in reducing workplace and overall daily sitting and increasing standing time in a real-world setting. The effect appears to have been sustained for 18 months, with mixed results in cardio-metabolic and productivity outcomes.

The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study

ObjectivesTo assess the long-term effect on health and well-being of the Lifestyle Matters programme.DesignQualitative study of a subset of intervention arm participants who participated in the Lifestyle Matters randomised controlled...

Efficacy of an enhanced linkage to HIV care intervention at improving linkage to HIV care and achieving viral suppression following home-based HIV testing in rural Uganda: study protocol for the Ekkubo/PATH cluster randomized controlled trial

BackgroundThough home-based human immunodeficiency virus (HIV) counseling and testing (HBHCT) is implemented in many sub-Saharan African countries as part of their HIV programs, linkage to HIV care remains a challenge. The purpose of this study is to test an intervention to enhance linkage to HIV care and improve HIV viral suppression among individuals testing HIV positive during HBHCT in rural Uganda.MethodsThe PATH (Providing Access To HIV Care)/Ekkubo Study is a cluster-randomized controlled trial which compares the efficacy of an enhanced linkage to HIV care intervention vs. standard-of-care (paper-based referrals) at achieving individual and population-level HIV viral suppression, and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis, and antiretroviral therapy initiation following HBHCT. Approximately 600 men and women aged 18-59 who test HIV positive during district-wide HBHCT in rural Uganda will be enrolled in this study. Villages (clusters) are pair matched by population size and then randomly assigned to the intervention or standard-of-care arm. Study teams visit households and participants complete a baseline questionnaire, receive HIV counseling and testing, and have blood drawn for HIV viral load and CD4 testing. At baseline, standard-of-care arm participants receive referrals to HIV care including a paper-based referral and then receive their CD4 results via home visit 2 weeks later. Intervention arm participants receive an intervention counseling session at baseline, up to three follow-up counseling sessions at home, and a booster session at the HIV clinic if they present for care. These sessions each last approximately 30 min and consist of counseling to help clients: identify and reduce barriers to HIV care engagement, disclose their HIV status, identify a treatment supporter, and overcome HIV-related stigma through links to social support resources in the community. Participants in both arms complete interviewer-administered questionnaires at six and 12 months follow-up, HIV viral load and CD4 testing at 12 months follow-up, and allow access to their medical records.DiscussionThe findings of this study can inform the integration of a potentially cost-effective approach to improving rates of linkage to care and HIV viral suppression in HBHCT. If effective, this intervention can improve treatment outcomes, reduce mortality, and through its effect on individual and population-level HIV viral load, and decrease HIV incidence.Trial registrationNCT02545673

Metacognition in speech and language therapy for children with social (pragmatic) communication disorders: implications for a theory of therapy.

Metacognition is a significant component of complex interventions for children who have developmental language disorders. Research into how metacognition operates in the content or process of developmental language therapy delivery is limited. Identification and description of proposed active therapy components, such as metacognition, may contribute to our understanding of how to deliver complex communication interventions in an optimal manner. To analyse aspects of metacognition during therapy derived from a manualized speech and language intervention (the Social Communication Intervention Programme-SCIP) as delivered to children who have social (pragmatic) communication disorder (SPCD) and to examine the dynamic process of delivering therapy. A purposive sample of eight filmed therapy sessions was selected from the video data corpus of intervention-arm participants within a randomized controlled trial. The child-therapist interactions during therapy sessions from five children (aged between 5;11 and 10;3) in the SCIP trial were transcribed. Filmed sessions represented a variety of communication profiles and SCIP therapy content. Starting from existing theory on metacognition, cycles of iterative analysis were performed using a mixed inductive-deductive qualitative analysis. A preliminary list of metacognitive content embedded in the intervention was developed into a metacognitive coding framework (MCF). A thematic analysis of the identified metacognitive content of the intervention was then carried out across the whole sample. Thematic analysis revealed the presence of metacognition in the content and delivery of SCIP intervention. Four main themes of metacognitive person, task and strategy knowledge, and monitoring/control were identified. Metacognition was a feature of how children's ability to monitor language, pragmatic and social interaction skills, in themselves and other people, was developed. Task design and delivery methods were found to play a particular role in adjusting the metacognitive content of the therapy activities. This study makes explicit the metacognitive content and delivery within a complex developmental communication intervention. Discussion of the findings about metacognitive content provides an explanation of how the skilled speech and language therapist manipulates task demands, person knowledge and therapy methods towards the therapy goal. Clinical applications of the metacognitive framework are discussed. We suggest that the process of making the tacit knowledge of the therapist explicit can contribute to the implementation of complex evidence-based interventions.

Feasibility intervention to increase exercise outcome expectations among breast cancer survivors.

e21584 Background: Exercise is associated with decreased mortality and recurrence risk and improved quality of life for breast cancer survivors (BCS). Roughly 1/3 of BCS exercise enough to experience these benefits. A promising strategy to increase exercise among BCS is to target outcome expectations (OEs), or what one expects to obtain or avoid from a behavior. OE dimensions include 1) importance – value placed on the outcome(s); 2) certainty - perceived probability outcome(s) will occur; and 3) accessibility – the frequency with which outcome(s) are considered. Methods: This RCT tested the feasbility and effects of a self-directed booklet designed to increase OEs and exercise. It was created in collaboration with BCS who successfully use exercise to manage long term side effects. OEs were measured through online surveys and exercise was measure with a Fitbit accelerometer. Data was collected at baseline, 4, 8 and 12 weeks post intervention. Feasibility was defined as the extent to which participants made use of intervention materials and was assessed through 9 researcher related questions. Results: The sample is mean age of 58, 74% white, 26% black, an average 2.5 years post treatment and about 1/3 take an AI or SERM. The booklet “somewhat” (mean = 3.24, SD = 1.8 on 1-5 Likert scale) made use of the booklet, as intended. OEs increased 0.01 points over time in the intervention arm, compared to the control arm ( p = 0.3555); 0.4 points more for black participants compared to white ( p = 0.0003); 0.2 points per every unit of increased exercise self-efficacy ( p &lt; 0.0001), and 0.01 points per month participants were closer to their time of cancer surgery ( p = 0.0037). Intervention arm participants increased their weekly steps by 970, every 4 weeks, compared to participants in the control arm ( p = 0.0283). Conclusions: Overall the intervention was well received by participants, had positive effects on OEs and exercise and can easily be translated into practice with need for minimal resources. Significant differences were noted for black compared to white participants, thus it is necessary to understand racial differences in exercise beliefs when designing future exercise interventions. Clinical trial information: NCT02348710.

Treatment seeking as a mechanism of change in a randomized controlled trial of a mobile health intervention to support recovery from alcohol use disorders

BackgroundWe estimated the efficacy of the Addiction-Comprehensive Health Enhancement Support System (A-CHESS) in increasing the use of services for addiction and examined the extent to which this use of services mediated the effects of A-CHESS on risky drinking days and abstinence from drinking. MethodsWe conducted secondary data analyses of the A-CHESS randomized controlled trial. Recruitment occurred in five residential treatment programs operated by two addiction treatment organizations. Participants were 349 adults with alcohol use disorders recruited two weeks before discharge from residential treatment. We provided intervention arm participants with a smartphone, the A-CHESS application, and an 8-month service plan. Control arm participants received treatment as usual. Telephone interviews at 4, 8, and 12-month follow-ups assessed past-month risky drinking days, past-month abstinence, and post-discharge service utilization (past-month outpatient addiction treatment and past-week mutual help including Alcoholics Anonymous and Narcotics Anonymous). Using mixed effects latent variable models, we estimated the indirect effects of A-CHESS on drinking outcomes, as mediated by post-discharge service utilization. ResultsApproximately 50.5% of participants reported outpatient addiction treatment and 75.5% reported mutual help at any follow-up interview in the year following randomization. Assignment to the A-CHESS intervention was associated with an increased odds of outpatient addiction treatment across follow-ups, but not mutual help. This use of outpatient addiction treatment mediated the effect of A-CHESS on risky drinking days, but not abstinence. The effect of A-CHESS through outpatient addiction treatment appeared to reduce the expected number of risky drinking days across follow-ups by 11%. ConclusionsThe mobile health (mHealth) intervention promoted the use of outpatient addiction treatment, which appeared to contribute to its efficacy in reducing risky drinking. Future research should investigate how mHealth interventions could link patients to needed treatment services and promote the sustained use of these services.

Outcomes of a Randomized Controlled Trial of Genomic Counseling for Patients Receiving Personalized and Actionable Complex Disease Reports

There has been very limited study of patients with chronic disease receiving potentially actionable genomic based results or the utilization of genetic counselors in the online result delivery process. We conducted a randomized controlled trial on 199 patients with chronic disease each receiving eight personalized and actionable complex disease reports online. Primary study aims were to assess the impact of in-person genomic counseling on 1) causal attribution of disease risk, 2) personal awareness of disease risk, and 3) perceived risk of developing a particular disease. Of 98 intervention arm participants (mean age=57.8; 39% female) randomized for in-person genomic counseling, 76 (78%) were seen. In contrast, control arm participants (n=101; mean age=58.5; 54% female) were initially not offered genomic counseling as part of the study protocol but were able to access in-person genomic counseling, if they requested it, 3-months post viewing of at least one test report and post-completion of the study-specific follow-up survey. A total of 64 intervention arm and 59 control arm participants completed follow-up survey measures. We found that participants receiving in-person genomic counseling had enhanced objective understanding of the genetic variant risk contribution for multiple complex diseases. Genomic counseling was associated with lowered participant causal beliefs in genetic influence across all eight diseases, compared to control participants. Our findings also illustrate that for the majority of diseases under study, intervention arm participants believed they knew their genetic risk status better than control arm subjects. Disease risk was modified for the majority during genomic counseling, due to the assessment of more comprehensive family history. In conclusion, for patients receiving personalized and actionable genomic results through a web portal, genomic counseling enhanced their objective understanding of the genetic variant risk contribution to multiple common diseases. These results support the development of additional genomic counseling interventions to ensure a high level of patient comprehension and improve patient-centered health outcomes.

Does Usage of an eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? Secondary Analysis From a Randomized Controlled Trial.

BackgroundExcessive gestational weight gain (GWG) contributes to the development of obesity in mother and child. Internet-based interventions have the potential for delivering innovative and interactive options for prevention of excessive GWG to large numbers of people.ObjectiveThe objective of this study was to create a novel measure of Internet-based intervention usage patterns and examine whether usage of an Internet-based intervention is associated with reduced risk of excessive GWG.MethodsThe website featured blogs, local resources, articles, frequently asked questions (FAQs), and events that were available to women in both the intervention and control arm. Weekly reminders to use the website and to highlight new content were emailed to participants in both arms. Only intervention arm participants had access to the weight gain tracker and diet and physical activity goal-setting tools. A total of 1335 (898 intervention and 437 control) relatively diverse and healthy pregnant women were randomly assigned to the intervention arm or control arm. Usage patterns were examined for both intervention and control arm participants using latent class analysis. Regression analyses were used to estimate the association between usage patterns and three GWG outcomes: excessive total GWG, excessive GWG rate, and GWG.ResultsFive usage patterns best characterized the usage of the intervention by intervention arm participants. Three usage patterns best characterized control arm participants’ usage. Control arm usage patterns were not associated with excessive GWG, whereas intervention arm usage patterns were associated with excessive GWG.ConclusionsThe control and intervention arm usage pattern characterization is a unique methodological contribution to process evaluations for self-directed Internet-based interventions. In the intervention arm some usage patterns were associated with GWG outcomes.ClinicalTrialClinicalTrials.gov; Clinical Trials Number: NCT01331564; https://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation/6nI9LuX9w)

Acceptability of a telecare intervention for persistent musculoskeletal pain

Introduction Persistent musculoskeletal pain is a prevalent, disabling, and often undertreated condition. This paper examines the acceptability of a telecare intervention for this condition. Methods The Stepped Care to Optimize Pain Care Effectiveness (SCOPE) intervention couples automatic symptom monitoring (ASM) with optimized analgesic care management by a nurse-physician team. Data from participants in the telecare intervention arm (n = 124) of a randomized control trial of SCOPE were analysed to determine the acceptability of the telecare intervention as indicated by patient use and satisfaction. Results Most (93.5%) patients completed at least one ASM report, selecting equally web-based (49%) or interactive voice-recorded (51%) reporting. The median number of ASM reports and nurse contacts per patient was 15 and 12, respectively. Of 12 demographic and clinical factors examined, none predicted the number of ASM reports, whereas nurse contacts were more frequent in patients with higher pain severity or receiving opioids. Only a minority of ASM reports required an expedited nurse call, with the most frequent alerts being for a medication change, a nurse call or side effects. Most (92%) patients rated ASM as easy to use and found the ASM reporting (76%) and nurse contacts (81%) very or moderately helpful. Nearly three-fourths of patients rated their overall pain treatment as good to excellent. The most common suggestions from patient feedback were for a free-text messaging function, more frequent nurse contact and less redundancy in ASM reporting items. Discussion Participants generally found the telecare intervention a user-friendly and helpful approach for treating persistent musculoskeletal pain.

ShopSmart 4 Health: results of a randomized controlled trial of a behavioral intervention promoting fruit and vegetable consumption among socioeconomically disadvantaged women

Behavioral interventions show potential for promoting increased fruit and vegetable consumption in the general population. However, little is known about their effectiveness or cost-effectiveness among socioeconomically disadvantaged groups, who are less likely to consume adequate fruit and vegetables. This study investigated the effects and costs of a behavior change intervention for increasing fruit and vegetable purchasing and consumption among socioeconomically disadvantaged women. ShopSmart 4 Health was a randomized controlled trial involving a 3-mo retrospective baseline data collection phase [time (T) 0], a 6-mo intervention (T1-T2), and a 6-mo no-intervention follow-up (T3). Socioeconomically disadvantaged women who were primary household shoppers in Melbourne, Australia, were randomly assigned to either a behavior change intervention arm (n = 124) or a control arm (n = 124). Supermarket transaction (sales) data and surveys measured the main outcomes: fruit and vegetable purchases and self-reported fruit and vegetable consumption. An analysis of supermarket transaction data showed no significant intervention effects on vegetable or fruit purchasing at T2 or T3. Participants in the behavior change intervention arm reported consumption of significantly more vegetables during the intervention (T2) than did controls, with smaller intervention effects sustained at 6 mo postintervention (T3). Relative to controls, vegetable consumption increased by ∼0.5 serving · participant(-1) · d(-1) from baseline to T2 and remained 0.28 servings/d higher than baseline at T3 among those who received the intervention. There was no intervention effect on reported fruit consumption. The behavior change intervention cost A$3.10 (in Australian dollars) · increased serving of vegetables(-1) · d(-1)CONCLUSIONS: This behavioral intervention increased vegetable consumption among socioeconomically disadvantaged women. However, the lack of observed effects on fruit consumption and on both fruit and vegetable purchasing at intervention stores suggests that further investigation of effective nutrition promotion approaches for this key target group is required. The ShopSmart 4 Health trial was registered at www.isrctn.com as ISRCTN48771770.