Single-arm Pilot Study Research Articles

Training of Nurse Interventionists to Optimize Intervention Fidelity in a Telehealth Pilot Study.

Interventionist training and on-going guidance by the research team are essential in psychosocial interventional research to ensure fidelity. Consistency in delivering an intervention requires recruiting interventionists with well-aligned clinical experience, developing a replicable training process, and reassessing ongoing intervention fidelity using an assessment tool of observable behaviors that are essential to the intervention. This paper describes one research team's experience of hiring and training nurse interventionists to deliver a theory-based, telehealth psychosocial intervention for a single-arm pilot study. The training methods used to foster the nurses' integration of theory into intervention delivery are discussed, along with approaches adopted to optimize and measure fidelity. The research team and interventionist trainees in this pilot study overcame learning challenges through establishing mutual trust and promoting effective communication throughout the training process. Fostering connections between cognitive and affective learning during the nurse interventionists' training was critical to establishing and maintaining intervention fidelity.

Pilot evaluation on an adapted tele-behavioral activation to increase physical activity in persons with depression: a single-arm pilot study

BackgroundPhysical activity has the potential to improve physical and mental health outcomes of persons with depression. However, feasible and acceptable strategies to integrate physical activity interventions into real-world settings are needed.ObjectiveTo assess the feasibility and acceptability of a manualized Behavioral Activation intervention aimed to increase physical activity in persons with depression (defined as a PHQ-9 score ≥ 10).MethodsA single-arm pilot study was conducted. The intervention consisted of 8 tele-therapy sessions delivered over a 10-week period. Measures of feasibility included screening, enrollment, intervention adherence, outcome data availability, and intervention fidelity. Acceptability was assessed with a post-intervention survey and qualitatively through focus groups and interviews. Preliminary efficacy of the intervention was assessed by evaluating pre-to-post changes in physical activity and depressive symptoms.ResultsAll feasibility metrics exceeded predetermined feasibility goal metrics with the exception of Fitbit wear and screening rate, which was due to a greater than anticipated enrollment rate. Participants (n = 15) reported perceived benefits from the intervention and convenience in attending tele-therapy sessions. Depressive symptoms, as measured by the PHQ-9 improved (16.8 at enrollment to 10.1 post intervention, Cohen’s d = 1.13). Self-reported moderate-to-vigorous physical activity (MVPA) increased from 22.0 min/week at baseline to 36.67 min/week post-intervention (d = 0.58). Physical activity as measured by the Fitbit showed little change (daily step 5543.29 during Week 1 to 6177.48 during Week 10, (d = 0.14); MVPA 21.23 min/week during Week 1 to 19.22 at Week 10 (d = 0.0.06).ConclusionsResults of the pilot study suggest the intervention is feasible to deliver and acceptable to participants. Preliminary results suggest the intervention may be effective in improving depressive symptoms and increasing self-reported physical activity.Trial registrationClinicalTrials.gov NCT04990401, Registered July 21, 2021.

Self-Collection for Primary HPV Testing: Acceptability in a Large Urban Emergency Department

Overdue cervical cancer screening increases the risk of invasive cervical cancer. It is important to identify settings where self-collection for primary human papillomavirus (HPV) testing can be implemented to have high effect on cervical cancer screening among hard-to-reach women with overdue screening. Herein, we examined the acceptability of HPV self-collection, including completion rates, attitudes, and experiences among women seeking noncritical care at a high-volume urban safety-net hospital emergency department (ED) in Houston, Texas, United States. In this single-arm intervention pilot study, we recruited women overdue for cervical cancer screening in the waiting areas of a safety-net hospital ED, seeking noncritical care from November 2023 to April 2024. Participants completed a preintervention survey and were offered an HPV self-collection kit. A postintervention survey followed immediately after HPV self-collection. Nearly 30% (119 of 401) screened for eligibility were overdue for cervical cancer screening. Of these, 93% were enrolled and were predominantly Hispanic, non-US born, and uninsured, with a median age of 45 years (IQR: 37 to 53). HPV self-collection completion rate was 90% (95% CI 82.9% to 94.9%). More than a quarter (27%) of these women had never been screened, and 14% had a screening >10 years prior. Most women who completed the HPV self-collection had positive attitudes and experiences and reported that the kit was easy to use (97%) and would be very willing to use HPV self-collection for regular screening (88%). HPV self-collection for primary cervical cancer screening during noncritical ED visits is possible and highly acceptable among women overdue for cervical cancer screening.

Evaluation of ANKOMMEN as a group intervention based on life story work for adolescents in residential care in Germany: a single-arm pilot study

BackgroundAdolescents face many challenges when coping with out-of-home placement, and life story work can be helpful in this context. Typically conducted in individual settings, life story work’s high resource requirements pose a challenge for implementation in the standard care of youth welfare institutions. To address this issue, the ANKOMMEN intervention was developed as a manualized group program for adolescents in residential care focusing on processing and coping with experiences associated with their out-of-home placement.MethodThe intervention was evaluated in a single-arm pilot study with questionnaires administered at three time points (pre-intervention, post-intervention, and 3-month follow-up). The primary outcome was self-efficacy, while secondary outcomes included self-esteem, depressive symptoms, posttraumatic stress symptoms, and behavioral problems. A total of 31 intervention groups with 115 adolescents (M = 14.91 years; SD = 1.45; 52.2% male) were conducted between October 2020 and September 2022 in Germany. Data were analysed using mixed effect models.ResultsPre-post comparisons revealed increased self-efficacy (d = −0.80) and self-esteem (d = −0.68) among participants with below-average scores prior to the intervention. Additionally, there was a decrease in self-reported depressive symptoms (d = 0.76), self-reported posttraumatic stress symptoms (d = 0.58), self-reported internalizing behavior problems (d = 0.74), caregiver-reported internalizing behavior problems (d = 0.76), and self-reported externalizing behavior problems (d = 0.52) for participants with clinically relevant scores prior to the intervention. These improvements were stable in the 3-month follow-up assessment. Furthermore, the intervention proved its feasibility in standard care within the context of the evaluation study.ConclusionsThe results of the pilot study provide preliminary evidence for the feasibility and potential effectiveness of ANKOMMEN but further research is needed to obtain valid evidence for the efficacy of the intervention.

Evaluating physical outcomes in elderly sport and dance rollator users

The present single-arm pilot study investigates the effects of a video-based dance intervention on physical outcomes in elderly individuals utilizing sports and dance rollators. In addition, the dance videos used in the current study are intended to integrate into the future Intercommunication Technology (ICT)-Rollator for the elderly. The aim is to evaluate the physical outcomes (such as gait, balance, mobility, and hand grip strength) during guided movement training (dance) using a video projected in a laboratory setting. The pilot study involved six elderly rollator users (aged 85 and above). In the initial assessment, subjects were screened for mobility and coordination limitations prior to pre-testing using a four-square-step test and the SF-36 questionnaire. Both pre-testing and post-testing included assessments of mobility, balance, and spatiotemporal gait parameters using the Timed Up-and-Go (TUG) test, Berg Balance Scale (BBS), and the Optogait system, respectively. Hand grip strength was measured using a hand dynamometer and reaction time was measured using a pipe-drop test. Blood pressure was monitored every 15 minutes during the training sessions to prevent adverse events, maintaining an upper range of 140-150/90-96. Adherence rates were measured based on the total duration of activity, calories burned per session, and dropout rates. Post-session questionnaires were administered to verify the respondents' qualitative evaluations of their degrees of exhaustion, enjoyment, impediments, facilitators, and suggested changes. The intervention included heart rate monitoring, which revealed gradual and slight increases in heart rate intensity and gradual decreases in heart rate ranges (HRR) during the dance sessions. The results indicate improvements in balance, mobility, gait, and adherence rates. Future longitudinal research will further examine the effectiveness of the dance intervention using the ICT-Rollator, comparing it to a control group using a conventional rollator. The ICT-Rollator could be a unique rehabilitation aid for the elderly, offering promising improvements.

A single-arm pilot study of a brief cognitive-behavioral therapy for insomnia intervention among Japanese occupational therapy and physical therapy university students with sleep disturbances

ObjectiveTo evaluate the feasibility of the Sleep Health through University Student Habits (SHUSH) program, a brief sleep improvement intervention based upon principles of cognitive-behavioral therapy for insomnia (CBT-I) developed for Japanese university students.MethodsPretest-posttest, single-arm pilot study design with 3-month follow up was used to evaluate the feasibility of SHUSH. We developed then offered a 90-min sleep education class based upon the two-process model of sleep regulation, sleep restriction, stimulus control, and sleep hygiene. We recommended individualized sleep prescriptions (e.g., prescribed time to bed and prescribed time out of bed) from 11 days of daily sleep diary data. We then offered 15 min of individualized follow-up meetings each week for three consecutive weeks in person or online in which we supported adherence to sleep prescriptions. Fifteen university students with self-reported sleep disturbance (Insomnia Severity Index; ISI score ≥ 9) completed the SHUSH program. Participants were on average age 19.7 years old; nine were women, and they were students in occupational therapy and physical therapy. We assessed validated Japanese versions of sleep-related (e.g., ISI, Sleep hygiene practice scale; SHPS), mental health-related (e.g., Generalized Anxiety Disorder Screener) patient-reported outcomes (PROs) and daily sleep diary variables (e.g., sleep onset latency and sleep efficiency).ResultsComparing baseline and posttest data, a statistically significant difference was observed in insomnia symptom severity, daytime sleepiness, sleep hygiene practices, eveningness to morningness, anxiety, depression, sleep diary improvements (e.g., sleep onset latency, total time in bed, and sleep efficiency). Comparing posttest and 3-mo follow up data (n = 10), a statistically significant difference wasn't observed for most PRO effects. However, there was a statistically significant difference in ineffective sleep behaviors (i.e., SHPS-J). We did observe a rebound effect for some SHPS-J items.ConclusionSHUSH was developed as a brief cognitive-behavioral intervention for insomnia. SHUSH participants showed improvements on sleep-related and mental health-related PROs after 4 weeks of intervention. At 3 months follow-up sleep quality and mental health gains were maintained. SHUSH was a feasible program. Randomized controlled trials are needed to test treatment efficacy on sleep related and mental health related PROs in the future.

A Short-Term Group Telehealth Cognitive Behavioral Therapy Intervention for Youth with Autism and Anxiety: A Pilot Study.

Background: Children with autism often present with comorbid anxiety disorders. Cognitive behavioral therapy (CBT) is an effective, evidence-based approach to treating anxiety, but information on youth with autism and anxiety is limited. Coping Cat is a 16-week CBT intervention for children with anxiety but its use in a group telehealth format in an urban, predominantly Hispanic population is limited. Objectives: (a) To examine the feasibility and preliminary effectiveness of a short-term CBT telehealth group for youth with autism and anxiety disorders in an urban, predominantly Hispanic population and (b) to examine satisfaction with the intervention. Methods: Single-arm pilot study that consisted of a 16-week telehealth CBT group therapy was based on a modified Coping Cat curriculum. Youth with autism and anxiety disorders who were on a waitlist for psychotherapy at an urban developmental center were invited to participate. Anxiety was assessed pre- and posttreatment using the Screen for Child Anxiety Related Emotional Disorders, parent and self-report. Results: Eighteen children were enrolled; 16 children completed the program. Mean age was 11 ± 2.5 years (8-15 years); 89% males, 61% Hispanic. There was a significant reduction in pre-post intervention in symptoms of overall anxiety (parent: 41.0 ± 18.5 to 31.0 ± 16.3 p ≤ 0.003, self: 25.9 ± 12.8 to 14.1 ± 7.8 p ≤ 0.001), panic disorder (parent: 8.1 ± 7.0 to 4.1 ± 4.2 p = 0.013, self: 5.1 ± 4.8 to 0.8 ± 0.9 p = 0.004), and separation anxiety disorder (parent: 7.5 ± 4.8 to 5.7 ± 4.4 p = 0.041, self: 5.8 ± 3.3 to 3.8 ± 2.4 p = 0.018) as per parent and self-reports. Self-report data also revealed a significant reduction in symptoms of social anxiety disorder (6.5 ± 3.5 to 3.9 ± 2.7 p ≤ 0.001). Parents and children reported satisfaction with the group. Conclusion: In this small, predominantly Hispanic population of youth with autism and anxiety disorder, 89% of families were compliant with a group telehealth CBT intervention. Parents and youth reported a significant reduction in anxiety symptoms and program satisfaction. A modified group CBT program via telehealth represents a feasible intervention for youth with autism and anxiety disorders.

Supporting Weight Loss Among Parents of Children With a Disability: Lessons Learned From a Single-Arm Pilot Study.

This study assessed weight change in the parents of children with disabilities following a 12-week, remotely delivered weight loss program focused on lifestyle modifications and found a significant median weight reduction of 3 kg from baseline to week 12.

7067 A Pilot Study on Levothyroxine Administration- Understanding the Effects on Thyroid Hormone Levels and Patient Compliance Without Restrictions on Food or Time

Abstract Disclosure: R. Patel: None. K. Pandya: None. D. Olson: None. Background- Hypothyroidism is one of the most common treatable endocrinological disorders that can be managed by replacement therapy. In most cases, compliance is a major hindrance for maintenance medications to express the intended effect. Thus, prescribing medications in a more convenient way would make it easier for the patients to remember and hence amplify compliance. Traditional practice dictates thyroid replacement medication to be administered early in the morning on an empty stomach for optimum absorption. This mandates some patients to set an alarm clock for early morning to take their thyroid medication, which can not just be cumbersome but also increase the chances of having a fall and can alter sleep hygiene as well. We aimed to identify if allowing patients with a more lenient approach in medication timing can help increase compliance while still maintaining thyroid hormone levels with fewer side effects. Methods- As an initial single-arm pilot study, we retrospectively looked at thirteen patients from a single center, for whom patient preference was respected in allowing them to take thyroid replacement in conjunction with any other medication, food, coffee, or any combination of those, as long as it was consistently taken the same way and at the same time each day. In this study, the patient population ranged in age from 44 to 95, with a mean age of 77.38. Most of these patients had follow-ups for over a decade while their TSH levels were observed with minimum follow-up duration being 4 years. Results- On the serial measurement of TSH on this patient cohort, it was discovered that patients were still euthyroid, ranging from 0.36 to 5.28 with a mean of 2.654. This euthyroid state was achieved without requiring any frequent monitoring or extraordinarily high doses of thyroid supplement hormones compared to patients following traditional measures for the same. The highest dose required to achieve Euthyroid status was no more than 125 mcg once/day without any major hormonal fluctuations or adverse events during their treatment course. Thus, indicating that the proposed amendment to thyroid replacement instructions did not negatively impact thyroid function Conclusion- Hence, we propose a more lenient approach to taking Thyroids supplements allowing the patients to take them more conveniently and hence improving the compliance, improving overall outcomes. This can primarily be applied to the elderly population, minimising potential harm, i.e., falls, and other limitations in an attempt to take it consistently. However, this will be further investigated through a clinical trial to gather more comprehensive data on outcomes as well as identify any potential limitations of this concept. Presentation: 6/2/2024

A TED Talk style patient video education intervention to improve care coordination for rural patients with early-stage cancer: A feasibility study.

236 Background: Effective care coordination is a key component of high-quality, patient-centered cancer care. However, cancer patients residing in rural areas often experience substantial barriers to care and suboptimal care coordination. To date, there is a paucity of interventions to improve care coordination for rural cancer patients. In this pilot trial, we assessed the feasibility and preliminary efficacy of a remote, tablet-based patient video education intervention focused on cancer care coordination among rural patients in Hawaii. Methods: We conducted a single-arm pilot study to assess the preliminary effects of a novel, TED-talk style patient video education intervention presented by clinicians and a patient advocate. Video content focused on cancer basics, care coordination, and self-advocacy. Eligible participants were newly diagnosed with early-stage cancer (I-III), within one month of starting adjuvant chemotherapy, able to speak/read English, and residing in rural areas (defined as RUCA ≥ 4). We assessed the feasibility and patient-reports of acceptability and satisfaction using semi-structured interviews. Validated instruments were administered at baseline and post-intervention and used to assess the preliminary effects of the intervention on patients’ perceptions of care coordination (CCI; Care Coordination Instrument) and self-advocacy (adapted Cancer Self-Advocacy Scale; Hagan et al. 2018). Descriptive statistics were used to assess study outcomes. Results: From 01/2022 to 12/2022, 19 patients enrolled on the study (21 approached); 74% were female, 42.1% identified as two or more races, 26.3% Asian, and 21.1% White. Mean age was 52.2. The majority of participants were receiving treatment for breast cancer. Five patients became ineligible after enrolling on the study (disease progression, relocation). 71.4% of eligible patients completed all assessments. No changes were observed in the overall perceptions of care coordination. Improved scores were observed for the CCI communication domain (+4.5; Cohen’s d = -0.76, 95% CI: -1.45, -0.03). For self-advocacy, there was an overall trend for improved scores for the informed decision making and connected strengths subscales. All participants reported high satisfaction with the intervention. Conclusions: Results support the preliminary feasibility, satisfaction, and acceptability of this intervention for rural patients. Although the effects on the overall perceptions of care coordination are unclear, preliminary data suggest that the intervention may improve communication aspects of care coordination and self-advocacy. Further study is needed to evaluate the intervention in other rural areas. Funding support: The HOPE Foundation for Cancer Research/SWOG. Clinical trial information: NCT05162404 .

Transanal intersphincteric under direct view in the jackknife position combined with laparoscopic total mesorectal excision for treating ultra-low rectal cancer.

To investigate the effect and clinical advantage of transanal intersphincteric (ISR) under direct view in the jackknife position combined with laparoscopic total mesorectal excision (TME) for treating ultra-low rectal cancer. Additionally, the feasibility of this surgical technique was evaluated. This was a retrospective, single-center, single-arm pilot study. Ten patients with ultra-low rectal cancer underwent treatment by the same surgical team for direct view transanal ISR combined with laparoscopic TME in the Department of Anorectal Surgery, Huizhou Central People's Hospital between January 2021 and June 2021. The relevant clinical data were collected and analyzed. All the patients underwent complete mesenteric resection without conversion to laparotomy. The circumferential and distal resection margins (CRM and DRM) were negative. The mean distance between the lower margin of the tumor and the anal margin was 2.8 ± 0.8 cm, and the mean margin of distal resection was 1.2 ± 0.2 cm. TNM pathological stages I, II, III, and IV were observed in 6, 2, 2, and 0 cases, respectively. The median follow-up period was 15 months (interquartile range, 8 months). The mean Wexner and Low Anterior Resection Syndrome scores at 12 months after ileostomy were 8.1 ± 2.1 and 22.4 ± 5.7, respectively. Transanal ISR under direct view in the jackknife position combined with laparoscopic TME is safe and feasible for the treatment of ultralow rectal cancer.

Evaluation of the usability and acceptability of the P-STEP® mobile app: feasibility study protocol

BackgroundThe new P-STEP® (Personalised Space Technology Exercise Platform) app is designed to bring together tailored exercise guidance and up-to-date air quality information. The app allows individuals to plan outdoor exercise walking routes while minimising their exposure to air pollution. Individuals with chronic long-term conditions, particularly respiratory and cardiovascular conditions, can use the app in order to minimise the risk of their symptoms being exacerbated by pollution, while still gaining the benefits of outdoor exercise.MethodsThis study will measure the usability and acceptability of the P-STEP® app. The study will take the form of a single-arm 12-week app pilot study based in Leicestershire, United Kingdom (UK). We will recruit a maximum of 380 participants from an existing cohort study to pilot the app for 12 weeks. Questionnaire data will be collected at three timepoints, baseline, 6 weeks and 12 weeks. The primary outcome is the System Usability Scale at 12 weeks. Secondary outcomes include the User Engagement Scale Short Form, SF-12, Recent Physical Activity Questionnaire (RPAQ), bespoke, app specific usability questions, and feasibility outcomes. Additional data collected includes participant demographic information, technology self-efficacy and adverse events. Weekly anonymised usage data from the app will also be collected by the app team and analysed separately to complement the questionnaire data.DiscussionThis study will help us better understand the feasibility and acceptability of using the P-STEP® in the community. The results will also help inform future studies.Ethics and disseminationThis study has received ethical approval from the South West Frenchay Research Ethics (23/SW/0060) Committee. There is no need for further approval from the Health Research Authority as the study is not taking place in the NHS. The ClinicalTrials.gov ID number is NCT05830318.

Acceptability and potential benefit of a self-compassion intervention for people living with amyotrophic lateral sclerosis: a mixed methods pilot study

Objective: This proof-of-concept study aimed to explore the acceptability and potential benefit of a self-guided online self-compassion intervention to aid resilient coping and reduce emotional distress among patients and caregivers living with ALS. Methods: A single-arm pilot study was conducted in 20 adults living with ALS either as a patient or as a caregiver. Acceptability was examined using questionnaires (n = 20) and semi-structured interviews (n = 9). Potential benefit was assessed as changes in self-compassion, self-criticism and emotional distress, determined using psychological questionnaires at 3 and 6 weeks. Questionnaires were analyzed using linear mixed-effects models and interview data using inductive thematic analysis. Results: Out of 20 participants who started the intervention, 16 completed the study (80%). The majority of study completers (12/16) were satisfied with the intervention, but the data suggest room for improvement in terms of personalization. Qualitative data revealed multiple psychological benefits of using the intervention, including self-kindness, emotional self-awareness and savoring. Although not statistically significant, quantitative data showed positive trends with increased self-compassion (mean difference: 2.07; 95% CI: −.5.76 − 1.63) and reduced self-criticism (mean difference: −2.62; 95% CI: −.1.97 − 7.23) and emotional distress (mean difference: −2.49; 95% CI: −.51 − 5.50) at week 6 compared to baseline. Conclusions: The findings suggest that a self-compassion intervention is acceptable to people living with ALS, but its beneficial effects and the mechanisms involved have yet to be established in larger and more diverse samples, using controlled designs.

The SMILE scale: a wellness behavioral tool for patients with cancer.

As cancer survivorship increases, there is a need for simple tools to measure and promote healthy behaviors. We created a wellness behavioral tool (the SMILE Scale) to encourage self-monitoring of wellness behaviors. This study aimed to determine the feasibility of collecting daily self-reported SMILE Scale data and weekly quality of life data among patients with cancer. We also aimed to measure the association between SMILE Scale responses and validated health-related quality of life (HRQOL) tools (PROMIS-29 + 2 and SymTrak-8) as a pilot test of the hypothesis that increased wellness behaviors may impact quality of life. We surveyed 100 patients with cancer at the Indiana University Simon Comprehensive Cancer Center. Participants were asked to complete daily SMILE Scale assessments over a two-week period, as well as weekly PROMIS-29 + 2 and SymTrak-8 surveys. The primary endpoint was the SMILE Scale completion rate. Secondary endpoints in this single-arm pilot study included correlations between the SMILE Scale and other HRQOL tools. Daily completion rate of the SMILE Scale ranged from 57% to 65% of participants over a 14-day period. Among the 61% of participants who completed SMILE on day 1, 87% completed SMILE on 10 of 14 days. By end of study, participants who self-reported more wellness behaviors (i.e., higher daily SMILE scores) demonstrated significantly higher PROMIS physical health (p = 0.003), higher PROMIS mental health (p = 0.008), and lower (better) SymTrak total symptom burden (p = 0.006). Further, among those who completed at least 1 of 14 daily SMILE assessments, quality of life significantly improved over the two-week period for PROMIS mental health (p = 0.018) and SymTrak total symptom burden (p = 0.014). The SMILE Scale completion rate did not satisfy our pre-planned ≥70% threshold for feasibility; however, the rate for completing SMILE at least once during the 14 days (77%) met this threshold. Participants with higher average daily SMILE scores had significantly better scores across other validated HRQOL tools. While these results may be correlative and not causative, this suggests a potential physical and mental health benefit for delivering the SMILE Scale in clinical practice to help encourage healthy behaviors and warrants testing the SMILE Scale's impact in future studies.

P038 DIAGNOSIS AND TREATMENT OF HYPERTENSION BY NON-PHYSICIAN HEALTHCARE WORKERS UNDER REMOTE SUPERVISION OF PHYSICIANS IS FEASIBLE AND EFFECTIVE IN RURAL BANGLADESH: PRELIMINARY RESULTS FROM CB-HEARTS PILOT STUDY

Background and Objective: In rural Bangladesh, there are multiple barriers to receiving treatment for hypertension, including distant healthcare facilities [Upazila Health Complex (UHC)] and inadequate numbers of physicians. This pilot aimed to design and assess the feasibility of implementing a community-based (CB) WHO HEARTS package involving non-physician health workers (Community Healthcare Providers [CHCP]) for diagnosing and treating hypertension who are remotely supervised, using telemedicine, by a UHC physician. Methods We are conducting this single-arm pilot study in four Community Clinics (CC) in rural Bangladesh. We included patients with untreated hypertension (blood pressure [BP] 140-180/90-110 mmHg). We excluded patients with diabetes, pregnancy, and cardiovascular and kidney diseases. The CB-HEARTS package intervention components were 1) simplified treatment protocol, 2) reliable medication supply, 3) team-based care, 4) standardized follow-up, and 5) a mobile app to track patients’ BP control. After assessing eligibility, CHCPs from the CC communicated with designated physicians at UHC to confirm hypertension diagnosis and to start anti-hypertensive medications in the CC. Patients with BP controlled (<140/90 mmHg) during follow-up were provided a refill for 3 months. Patients with complications or uncontrolled BP, even after the maximum allowable dose, were referred to the UHC. Outcomes were enrollment and follow-up rates (primary), BP change from baseline and hypertension control (secondary). Results: We screened 4,220 adults, of whom 531 were eligible for the study and 220 were enrolled (Table; mean age 55.9 years, 75.9% female). Enrollment (41.4%) and follow-up within 3 months of enrollment (93.6%) rates were high. Mean systolic and diastolic BP were 153 and 92 mmHg at enrollment, respectively. BP was lowered by 31 mmHg systolic and 15 mmHg diastolic after a mean of 84 days follow-up. After this follow-up duration, 90% of participants had their BP controlled. Conclusions: This pilot study provides evidence that hypertension care provided by non-physician health workers under remote supervision of physicians in rural Bangladesh is feasible and may effectively lower BP and improve hypertension control. Table: Participant screening, enrollment, and follow-up

Transforming Veteran Rehabilitation Care: Learnings from a Remote Digital Approach for Musculoskeletal Pain.

While musculoskeletal pain (MSP) stands as the most prevalent health condition among Veterans, timely and high-quality care is often hindered due to access barriers. Team Red, White & Blue (Team RWB), a nonprofit organization dedicated to promoting a healthier lifestyle among Veterans, aimed to assess innovative approaches to veteran care. This is a single-arm pilot study investigating the feasibility, clinical outcomes, engagement, and satisfaction of a remote multimodal digital care program among Veterans with MSP. The impact of deployment experience on outcomes was explored as a secondary aim. From 75 eligible Veterans, 61 started the program, reporting baseline pain frequently comorbid with mental distress. Program acceptance was suggested by the high completion rate (82%) and engagement levels, alongside high satisfaction (9.5/10, SD 1.0). Significant improvements were reported in all clinical outcomes: pain (1.98 points, 95%CI 0.13; 3.84, p = 0.036); mental distress, with those reporting at least moderate baseline depression ending the program with mild symptoms (8.50 points, 95%CI: 6.49; 10.51, p = 0.012); daily activity impairment (13.33 points, 95%CI 1.31; 25.34, p = 0.030). Deployed Veterans recovered similarly to their counterparts. Overall, the above results underscore the potential of a remote digital intervention to expand Veterans' access to timely MSP care.

Promoting serious illness conversations in primary care through telehealth among persons living with cognitive impairment.

serious illness conversations (SIC), particularly for persons living with cognitive impairment (PLCI), inconsistently happen in primary care. Pragmatic, scalable strategies are needed to promote SIC for PLCI. Pragmatic, prospective single-arm pilot study that occurred between July 1, 2021 and May 30, 2022 across seven primary care practices in North Carolina. Community-dwelling patients aged 65 and older with known or probable mild cognitive impairment or dementia (with decision-making capacity) and their care partners (if available). SIC telehealth intervention (TeleVoice) via video or telephone to assist PLCI in discussing their current goals, values, and future medical preferences, while facilitating documentation within the EHR. Main feasibility outcomes included reach/enrollment, intervention completion, and adoption rates at the clinic and provider level. Primary effectiveness outcomes included SIC documentation and quality within the EHR and usage of advance care planning billing (ACP) codes. Of the 163 eligible PLCI approached, 107 (66%) enrolled (mean age 83.7 years, 68.2% female, 16.8% Black, 22% living in a geographic area of high socioeconomic disadvantage) and 81 (76%) completed the SIC telehealth intervention; 45 care partners agreed to participate (mean age 71.5 years, 80% female). Adoption at clinic level was 50%, while 75% of providers within these clinics participated. Among PLCI that completed the intervention, SIC documentation and usage of ACP billing codes was 100% and 96%, respectively, with 96% (n = 78) having high-quality SIC documentation. No significant differences were observed between telephone and video visits. These findings provide preliminary evidence to support the feasibility of conducting SICs through telehealth to specifically meet the needs of community-dwelling PLCI. Further investigation of the sustainability of the intervention and its long-term impact on patient and caregiver outcomes is needed.

Endoscopic Membranectomy's Role in the Treatment of Nonhomogeneous Chronic Subdural Hematoma (EMiT-CSDH): Prospective Single-arm Interventional Pilot Study

Chronic subdural hematoma (CSDH) is a prevalent neurosurgical condition characterized by blood accumulation within the border cell layer. Despite various treatment options-medical, endovascular, and surgical-recurrence rates remain high. Our pilot study investigates the safety and efficacy of endoscopic membranectomy (EM) in reducing recurrence in nonhomogenous CSDH. This was a prospective single-arm interventional pilot study from March to June 2023. It included patients of all ages who presented with symptomatic nonhomogenous CSDH requiring surgical intervention. A total of 19 patients were enrolled in this study. The average age was 60.4 ± 10.4 years. The male:female ratio was 5.3:1. In this group, 73.7% (n= 14) of patients had a history of trauma. All patients presented with a history of altered sensorium and contralateral limb weakness. The most common type of CSDH was trabecular (42.1%), followed by gradient (21%), separated (15.8%), and laminar (15.8%). The average duration of surgery was 43.42 ± 10 minutes. CSDH may be thin or thick based on its tractability and has significance in EM technique. All patients started recovering within 24 hours. All patients were asymptomatic, without any neurologic deficit, at 2 weeks, and remained so at the 6-month review. In 17 patients, the 6-month follow-up computed tomography did not show any bleeding/recurrence. There were no postoperative seizures, wound-healing issues, or infections. There are multiple treatment options for CSDH at present. EM is a potentially safe and effective treatment for CSDH, with lower recurrence and faster recovery. Large-scale controlled studies on EM are required.

Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial

BackgroundCigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.ObjectiveTo investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.MethodsA prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.DiscussionAs tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial.Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652.

Facilitating the Virtual Exercise Games for Youth with T1D (ExerT1D) Peer Intervention: Protocol Development and Feasibility.

Barriers to moderate-to-vigorous physical activity (MVPA) for adolescents with type 1 diabetes (T1D) include physiology, transition to autonomy, and diabetes-specific stigma. Opportunities for T1D peer activities with T1D role model support are limited. To address this need, our single-arm pilot study tested the Home-based Virtual Activity Program for Youth with T1D (HAP-V-T1D) for feasibility. Participants (n=15) were mean age 15.6 [SD 1.5] years, 7 non-Hispanic white, 6 female, 2 non-binary, mean A1c 8.9%±2.2%. The program included an MVPA videogame, physician-led education regarding managing T1D around MVPA, objective habitual MVPA goal-setting , and T1D management skills guided by young adult instructors living with T1D. For feasibility, 13/15 participants attended 10/12 sessions. Participants' perceptions of the program, comfort, instructors, and group cohesion were rated high/very high (4.2±0.5 to 4.8±0.3 out of 5).Motivation for the videogame was also high (4.1±0.4 out of 5). Instructor-adolescent interactions related to building T1D management skills were rated as excellent for 78% of sessions. Similarly, sharing knowledge and experiences were rated as excellent for 68% of sessions. However, adolescent-adolescent interactions were poor (communication 29% excellent, peer interactions 8% excellent). The most reported barriers to participation were negative mood and oversleeping. No participants experienced diabetic ketoacidosis, severe hypoglycemia, or injuries during the study period. Compared to baseline, glycemic metrics appeared to decrease during and post intervention (d= -0.72, -1.12). HAP-V-T1D facilitated unprecedented T1D peer support achievements by engaging diverse youth with T1D in an MVPA program led by T1D role models. Larger studies are needed to assess if this intervention can improve glycemic measures and reduce diabetes-specific stigma.