Single-arm Pilot Research Articles

Developing and Testing a Two-Part Intervention: Enhancing Dementia Instruction and Tool in Home Hospice Care.

Family care partners (FCP) of persons living with dementia provide extensive care and experience significant stress. Hospice nurses and social workers seldom receive training to help FCP. This article describes the development and pilot testing of Enhancing Dementia Instruction and Tool in Home Hospice Care (EDITH-HC). This intervention provides 1) instructional videos for clinicians about dementia-specific end-of-life care and 2) a worksheet for clinicians and FCP to complete together to identify and address FCP stressors and concerns. EDITH-HC development involved co-developing and revising draft intervention materials based on two rounds of structured input from FCP (n = 10), hospice nurses and social workers (n = 5), and research/content experts (n = 4); and a single-arm pilot test of the intervention to assess initial feasibility and acceptability (n = 13). Initial pilot testing indicates the intervention is feasible and acceptable. A larger randomized pilot study to determine feasibility and acceptability is underway.

Feasibility study to improve oral health in older adult patients using visiting nursing services: A pilot study.

Among older adults in Japan, those requiring long-term care who use visiting nursing services have particularly poor oral health. Given the importance of oral health, this study aims to evaluate the feasibility of oral health improvement interventions for such older adult patients using visiting nursing services. This study was a single-arm pilot study. The participants were those who provide oral care to older adults who use visiting nursing services, whether the patients themselves or their family members. Participants implemented oral care appropriate to the patient's oral environment at least once a day for four weeks. Feasibility assessment consisted of the recruitment, completion, and compliance rates. Changes in the oral environment were measured using the Oral Health Assessment Tool-Japanese (OHAT-J), and changes in scores were assessed over the study period. The study was conducted across three visiting nursing stations, with 52 participants (a recruitment rate of 73.2%). Of these, 42 participants completed the final questionnaire (a completion rate of 80.8%). The compliance rate was 64.3%. The mean OHAT-J score was 4.5 (SD 2.3) pre-intervention, 3.7 (SD 2.0) at one week post-intervention, and 3.6 (SD 2.2) at four weeks post-intervention (p < 0.001), indicating a significant positive trend. The feasibility of this intervention was generally satisfactory, and the results showed that the oral environment was improved. Future studies with a larger scale and higher level of evidence should be conducted to evaluate the effectiveness of the intervention.

Impact of low-dose sevoflurane with propofol-based anesthesia on motor-evoked potentials in infants: a single-arm crossover pilot study

Abstract Purpose The influence of anesthetic interactions on motor-evoked potentials in infants has rarely been reported. In infants, adding a small dose of sevoflurane to propofol-based total intravenous anesthesia is reasonable for reducing propofol administration. We collected preliminary data regarding the effect of low-dose sevoflurane in propofol-based total intravenous anesthesia on motor-evoked potentials in infants. Methods This pilot interventional study included 10 consecutive infants requiring motor-evoked potentials between January 2023 and March 2024. The motor-evoked potential amplitudes in the upper and lower extremities were recorded twice when general anesthesia was maintained using (1) propofol-based total intravenous anesthesia and (2) 0.1–0.15 age-adjusted minimum alveolar concentration sevoflurane + propofol-based total intravenous anesthesia. Results The motor-evoked potential amplitude in the right upper extremity was not significantly different after the addition of a small dose of sevoflurane [192 (75.3–398) μV, 121 (57.7–304) μV, P = 0.19]. All the motor-evoked potential amplitudes in the right lower extremity (quadriceps femoris, anterior tibialis, and gastrocnemius muscles) were significantly attenuated by adding a small dose of sevoflurane (median [interquartile range]: 47.9 [35.4–200] μV, 25.2 [12.4–55.3] μV, P = 0.014; 74.2 [51.9–232] μV, 31.2 [2.7–64] μV, P = 0.0039; 29.8 [20–194] μV, 9.9 [3.8–92.4] μV, P = 0.0039, respectively). Similar results were observed in the left lower extremities. Conclusion Adding even 0.1–0.15 age-adjusted minimum alveolar concentration sevoflurane to propofol-based total intravenous anesthesia attenuated the motor-evoked potential amplitudes in the lower extremities. A further prospective interventional study with an appropriate sample size is required to investigate the study hypothesis.

Safety and Feasibility of Early Activity-Based Therapy Following Severe Traumatic Spinal Cord Injury: Results from a Single-Arm Pilot Trial.

Early activity-based therapy (E-ABT) has the potential to decrease complications and radically improve neurofunctional recovery following traumatic spinal cord injury (TSCI). Unfortunately, E-ABT after TSCI has never been attempted in humans due to practical obstacles and potential safety concerns. This study aims to report on the safety and feasibility outcomes of the Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI (PROMPT-SCI) trial: the first-ever trial of E-ABT in critically ill patients who suffered a severe TSCI. To do so, 45 patients with severe TSCI were recruited to participate in the PROMPT-SCI trial between April 2021 and August 2023. The intervention consisted of daily 30-min sessions of motor-assisted in-bed leg cycling for 14 days, starting within 48 h of early surgery (≈72 h from the initial trauma). Adverse events were closely monitored, and completion rates were evaluated. Out of the 45 participants, 36 (80%) completed a full and safe session within 48 h of surgery and all participants managed to achieve this outcome within 72 h of surgery. Over the full 14-day protocol, the average completion rate of sessions was 87.2 ± 22.7% (range: 7.1-100.0%). A total of three patients were mechanically ventilated during the protocol and all three had 100% completion of sessions. Frequent reasons for unattempted/incomplete sessions were scheduling conflicts with activities related to care (e.g., bronchoscopy) and fatigue/uncontrolled pain before initiating cycling. We also report no neurological deterioration caused by cycling and no major adverse event recorded during or between sessions. In conclusion, this study suggests that E-ABT can be safely initiated within 48-72 h after a severe TSCI with no major adverse event. In the form of daily passive in-bed leg cycling, E-ABT is also acceptable for target users, and feasible over the course of the first weeks after the initial trauma, as shown by our excellent rate of completed sessions (87%). The present results also suggest that improved collaboration with intensive care unit staff, including intensivists and nurses, could improve these rates even further.

Romiplostim, low-dose rituximab and high-dose dexamethasone for newly diagnosed immune thrombocytopenia: A pilot study.

Therapies such as corticosteroids, thrombopoietin receptor agonists and immunomodulators have been consistently under the spotlight in the search for a better treatment for immune thrombocytopenia (ITP). However, none of them has been widely embraced as a new standard. In this pilot study, we investigated feasibility, safety and preliminary efficacy of romiplostim, low-dose rituximab and high-dose dexamethasone for newly diagnosed ITP. We conducted a single-centre single-arm pilot. One-month treatment adherence was 100%. The 1-month overall response rate was 92.3%. Complete response occurred in 11 (84.6%) patients. Median duration of response was 4.13 monts (range 0.2-25). No serious adverse events presented.

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.

Development and feasibility testing of a new device for home-based leg heat therapy in patients with lower extremity peripheral artery disease

ObjectivePeople with symptomatic lower extremity peripheral artery disease (PAD) suffer from severe leg pain, walking impairment, and reduced quality of life, but few effective treatments are available. Emerging evidence suggests that regular heat therapy (HT) may improve cardiovascular and physical function in patients with PAD. However, the lack of accessible, practical modalities for unsupervised HT, especially for elderly individuals, hinders clinical implementation. The goals of this study were to design and assess the feasibility of a portable leg HT system for elderly patients with PAD. MethodsBuilding on a cryotherapy water-circulating device used in sports recovery, we developed a new prototype system consisting of a single-touch controller unit integrating a heater, water pump, and air pump, and leg sleeves with inner-layer water-circulating pads and an outer layer of inflatable bladders. The system was designed to ensure efficient heat transfer through gentle pneumatic inflation, adapting to varying limb dimensions. Safety features included temperature sensors with auto shut-off and a built-in timer. The prototype's feasibility and safety were evaluated in a single-arm pilot trial with six symptomatic patients with PAD, who were asked to apply the therapy daily for 90 minutes for 12 weeks. Primary outcomes included completion rates, safety, and device usability. Secondary outcomes were changes in blood pressure, 6-minute walk distance, calf strength, sit-to-stand performance, and quality of life. ResultsParticipants underwent a 90-minute supervised treatment session with the prototype HT units to assess the acute physiological responses before starting the 12-week intervention. Leg HT gradually increased leg skin temperature from 33.8 ± 0.8°C to 38.7 ± 0.7°C at 90 minutes and reduced arterial blood pressure, with mean reductions of 13 mm Hg in systolic and 12 mm Hg in diastolic blood pressure after treatment. All participants completed the 12-week program without serious adverse events, indicating that leg HT is safe and well-tolerated. The 6-minute walk distance improved by an average of 32 m, coupled with increased calf muscle strength and reduced time for the sit-to-stand test. Improvements were also observed in self-reported walking speed and quality of life. ConclusionsThis study represents the first step in developing a portable leg heating system for elderly patients with PAD, demonstrating that home-based leg HT is feasible and safe. However, further engineering refinements are needed to enhance portability, simplify application, and encourage long-term adherence. Developing methods to track compliance with the treatment regimen will be crucial for the success of this unsupervised, home-based therapy.

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.

Study protocol for a single-arm pilot trial investigating the feasibility of a multimodal digital technology for managing metabolic syndrome in patients with chronic obstructive pulmonary disease

Individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD) are exposed to an increased risk of metabolic syndrome (MetS), which negatively affects their health outcomes and quality of life. Lifestyle interventions have shown promise in managing MetS. This study outlines the protocol for a web-based multimodal self-care program, Digital Metabolic Rehabilitation, for managing MetS in patients with COPD. The Digital Metabolic Rehabilitation is a single-arm pilot trial that integrates the Canadian Health Advanced by Nutrition and Graded Exercise (CHANGE) Program and a web-based wellness platform. The web-based wellness platform employed in this study is My Viva Plan (MVP)®, which integrates a holistic, multicomponent approach to promote wellness. The intervention will primarily focus on lifestyle changes for patients with COPD. Over 6 months, participants will use the web-based wellness platform and engage in weekly online support group sessions. Fifty patients diagnosed with stage I-II COPD and MetS will participate. Blood tests, anthropometrics, body composition, physical function, muscle strength, physical activity, energy metabolism, quality of life and mental health will be assessed at baseline, 3, and 6 months. The Digital Metabolic Rehabilitation program aims to explore whether a multimodal integrative intervention delivered through a web-based wellness platform can be implemented by patients with COPD with MetS. By combining the expertise of the CHANGE Program with the digital delivery format, the intervention seeks to enhance self-monitoring and foster better self-management practices. The protocol outlines a novel and potentially impactful intervention for managing MetS in patients with COPD.

Adapting behavioral activation for patients receiving medications for opioid use disorder in primary care: a pilot study.

Effective adjunctive therapeutic treatments for patients with opioid use disorder (OUD) on medication for OUD (MOUD) in primary care settings are needed to address high rates of mental illness and stress. Behavioral activation (BA) is a brief, evidence-based therapy that has potential to improve quality of life in people with OUD. The purpose of this pilot study was to evaluate the feasibility and acceptability of values-based BA (VBA) as an adjunct treatment for patients receiving MOUD in primary care. Participants were recruited for a single-arm pilot trial of BA in a primary care setting. VBA was adapted for people with OUD and included 4-6 sessions delivered over 12 weeks with a behavioral health consultant, either in-person or virtually. Feasibility was assessed as recruitment percent and pace and retention percent. Acceptability was assessed with the Client Satisfaction Questionnaire-8 (CSQ-8). Participants completed self-report measures of well-being, depression, substance use, and psychological processes of change at baseline, mid-intervention (6-weeks), and post-intervention (12-weeks). Participants engaged in a brief interview about their experiences at the end of the intervention. Twenty-one participants enrolled in the intervention (66.7% female, M age = 44.0 years, 19% of those invited). Participants completed an average of 5.1 BA sessions (SD = 1.6) and most (90%) were retained through 12 weeks. Participants rated the intervention as highly acceptable on the CSQ-8 (M = 30.4/32.0, SD = 1.6). In qualitative interviews, participants reported that working with the therapist and setting values-based goals were helpful, while also recommending more tailoring to patients' needs and offering the program early in MOUD treatment. Preliminary efficacy data suggest the program was associated with small to moderate improvements in life satisfaction (Cohen's d = 0.25) and positive affect (d = 0.62), whereas there were no changes in depression (d = 0.09) or negative affect (d = -0.07) in a group with low depression at baseline. VBA adapted for patients on MOUD in primary care was feasible to deliver and acceptable to participants. Minor modifications to the target population and treatment manual could increase the program's impact. Future studies will test the efficacy of the intervention in improving quality of life and OUD treatment outcomes. https://clinicaltrials.gov/study/NCT05262725, Unique ID: NCT05262725.

Evaluating the World Health Organization's HEARTS Model for Hypertension and Diabetes Management: A Pilot Implementation Study in Guatemala.

The World Health Organization HEARTS Technical Package is a widely implemented global initiative to improve the primary care management of cardiovascular disease risk factors. The study's objective is to report outcomes from a pilot implementation trial of integrated hypertension and diabetes management based on the HEARTS model in Guatemala. We conducted a single-arm pilot implementation trial over 6 months from October 2023 to May 2024 in 11 Guatemalan Ministry of Health primary care facilities in two districts. The pilot evaluated a package of five HEARTS-aligned implementation strategies to improve the pharmacological treatment of hypertension and diabetes. The primary outcomes were feasibility and acceptability, measured through 20 structured interviews with Ministry of Health employees and by examining enrollment and retention. Secondary outcomes included a suite of implementation and clinical outcomes, including treatment rate. The study enrolled 964 patients, of whom 58.8% had hypertension only, 30.4% had diabetes only, and 10.8% had both conditions. Surveys on feasibility and acceptability among Ministry of Health staff had a median score of 5.0 (IQR: 5.0 to 5.0) and 5.0 (IQR range: 4.8 to 5.0), respectively, exceeding the prespecified benchmark of ≥3.5. Both districts achieved the prespecified benchmark of enrolling ≥25 hypertension patients and ≥25 diabetes patients. Only 36% of patients attended a follow-up visit within three months, lower than the prespecified benchmark of ≥75%. M treatment rates during the pilot increased by 22.3 (95% CI: 16.2 to 28.4; P<0.001) and 3.5 (95% CI: -1.6 to 8.7; P=0.17) patients per month for hypertension and diabetes, respectively. Implementation of an integrated hypertension and diabetes model based on HEARTS was generally feasible and acceptable in the Ministry of Health in Guatemala. Findings can refine national scale-up in Guatemala and inform HEARTS implementation projects in other settings.

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

The Impact of a Breast Cancer Risk Assessment on the Decision for Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Individuals: A Pilot Single-Arm Educational Intervention Trial.

Persons assigned female or intersex at birth and identify as transgender and/or gender-diverse (TGD) may undergo gender-affirming chest masculinization surgery (GACMS); however, GACMS is not considered equivalent to risk-reducing mastectomies (RRM). This study aimed to estimate the prevalence of elevated breast cancer (BC) risk in TGD persons, compare self-perceived versus calculated risk, and determine how risk impacts the decision for GACMS versus RRM. A prospective single-arm pilot educational intervention trial was conducted in individuals assigned female or intersex at birth, age ≥ 18 years, considering GACMS, without a BC history or a known pathogenic variant. BC risk was calculated using the Tyrer-Cuzik (all) and Gail models (age ≥ 35 years). Elevated risk was defined as ≥ 17%. Twenty-five (N = 25) participants were enrolled with a median age of 24.0 years (interquartile range, IQR 20.0-30.0 years). All were assigned female sex at birth, most (84%) were Non-Hispanic (NH)-White, 48% identified as transgender and 40% as nonbinary, and 52% had a first- and/or second-degree family member with BC. Thirteen (52%) had elevated risk (prevalence 95% confidence interval (CI) 31.3-72.2%). Median self-perceived risk was 12% versus 17.5% calculated risk (p = 0.60). Of the 13 with elevated risk, 5 (38.5%) underwent/are scheduled to undergo GACMS, 3 (23%) of whom underwent/are undergoing RRM. Over half of the cohort had elevated risk, and most of those who moved forward with surgery chose to undergo RRM. A BC risk assessment should be performed for TGD persons considering GACMS. Future work is needed to examine BC incidence and collect patient-reported outcomes. Trial Registration Number ClinicalTrials.gov (No. NCT06239766).

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 .