Pilot Feasibility Study Research Articles

Reducing stigma and improving access to care for people with mental health conditions in the community: protocol for a multi-site feasibility intervention study (Indigo-Local)

BackgroundStigma and discrimination towards people with mental health conditions by their communities are common worldwide. This can result in a range of negative outcomes for affected persons, including poor access to health care. However, evidence is still patchy from low- and middle-income countries (LMICs) on affordable, community-based interventions to reduce mental health-related stigma and to improve access to mental health care.MethodsThis study aims to conduct a feasibility (proof-of-principle) pilot study that involves developing, implementing and evaluating a community-based, multi-component, awareness-raising intervention (titled Indigo-Local), designed to reduce stigma and discrimination and to increase referrals of people with mental health conditions for assessment and treatment. It is being piloted in seven sites in five LMICs—China, Ethiopia, India, Nepal and Tunisia—and includes several key components: a stakeholder group workshop; a stepped training programme (using a ‘Training of Trainers’ approach) of community health workers (or similar cadres of workers) and service users that includes repeated supervision and booster sessions; community engagement activities; and a media campaign. Social contact and service user involvement are instrumental to all components. The intervention is being evaluated through a mixed-methods pre-post study design that involves quantitative assessment of stigma outcomes measuring knowledge, attitudes and (discriminatory) behaviour; quantitative evaluation of mental health service utilization rates (optional, where feasible in sites); qualitative exploration of the potential effectiveness and impact of the Indigo-Local intervention; a process evaluation; implementation evaluation; and an evaluation of implementation costs.DiscussionThe output of this study will be a contextually adapted, evidence-based intervention to reduce mental health-related stigma in local communities in five LMICs to achieve improved access to healthcare. We will have replicable models of how to involve people with lived experience as an integral part of the intervention and will produce knowledge of how intervention content and implementation strategies vary across settings. The intervention and its delivery will be refined to be feasible and ready for larger-scale implementation and evaluation. This study thereby has the potential to make an important contribution to the evidence base on what works to reduce mental health-related stigma and discrimination and improve access to health care.

Coping Power at the REACH School Network: A pilot feasibility study

Abstract Objectives School-based health centres (SBHCs) provide developmental and mental health care to children with socioeconomic disparities. We piloted a validated behavioural intervention called Coping Power (CP) for children with disruptive behaviour through our SBHC program. The objective of this pilot study was to examine the feasibility of CP in the SBHC setting. Methods All parent/caregiver and child dyads enrolled in CP from 2018 to 2019 and 2021 to 2022 were invited to participate in the study. Demographic information and behaviour rating scales were collected at baseline. Feasibility metrics included attendance and satisfaction survey responses. Results A total of 31 parent/caregiver-child dyads were included. Approximately 40% of families had an annual income of <$49,999. Regarding attendance, 22/31 children/parent/caregiver dyads (70.9%) missed ≤2 sessions. Thirteen parents/caregivers completed the CP satisfaction survey and indicated that they were either ‘somewhat’ (n = 4) or ‘very satisfied’ (n = 9) with the program. Of the 18 children who completed the satisfaction survey, 13 (72.2%) shared that either the ‘sort of’ or ‘for sure’ group helped them cope with their anger better. Conclusions This pilot study found that CP delivered within the SBHCs was feasible. Improving access to CP for disadvantaged children may improve mental health outcomes.

Novel Multicomponent Digital Care Assistant and Support Program for People After Stroke or Transient Ischaemic Attack: A Pilot Feasibility Study.

Evidence is increasing for digital health programs targeting the secondary prevention of stroke. We aimed to determine the feasibility of the novel Care Assistant and support Program for people after Stroke (CAPS) or transient ischaemic attack (TIA) by combining person-centred goal setting and risk-factor monitoring through a web-based clinician portal, SMS messages, a mobile application (app), and a wearable device. We conducted a 12-week mixed-methods, open-label feasibility study. Participants (6 months-3 years after stroke or TIA, access to the internet via a smartphone/tablet) were recruited via the Australian Stroke Clinical Registry. Participants set one or two secondary prevention goals with a researcher and provided access and training in technology use. Feasibility outcomes included recruitment, retention, usability, acceptability, and satisfaction. Secondary outcomes included goal attainment, health outcomes, and program costs. Following 600 invitations, 58 responded, 34/36 (94%) eligible participants commenced the program (one withdrawal; 97% retention), and 10 were interviewed. Participants (27% female, 33% TIA) generally rated the usability of the mobile application as 'Good' to 'Excellent' (System Usability Scale). Most (94%) agreed the program helped with engagement in health self-monitoring. Overall, 52 goals were set, predominantly regarding exercise (21/52), which were the most frequently achieved (9/21). At 12 weeks, participants reported significant improvements (p < 0.05) in self-efficacy (Cohen's d = 0.40), cardiovascular health (d = 0.71), and the mental health domain of the PROMIS GH (d = 0.63). CAPS was acceptable, with good retention and engagement of participants. Evaluation of this program in a randomised controlled trial is warranted.

Evaluation of a novel nerve ablation technique to relieve lower back pain: A cadaveric feasibility pilot study.

Radiofrequency ablation is a treatment for facetogenic low back pain that targets medial branches of lumbar dorsal rami to denervate facet joints. Clinical outcomes vary; optimizing cannula placement to better capture the medial branch may improve clinical outcomes. A novel parasagittal technique was proposed from an anatomical model; this technique was proposed to optimize capture of the medial branch. The anatomical feasibility of the novel technique has not been evaluated. To simulate and evaluate the proposed parasagittal technique in its ability to achieve proper cannula placement, and proximity of uninsulated cannula tips to the medial branches of the dorsal rami in cadaveric specimens. Under fluoroscopic guidance, 14 cannulae were placed using the parasagittal technique targeting the lumbar medial branches of two cadavers. Meticulous dissection was undertaken to assess cannula alignment and measure proximities to target nerves using a digital caliper. The novel parasagittal technique was successfully performed in a cadaveric model in 12/14 attempts. The technique achieved close proximity of cannula tips to medial branches (0.8 ± 1.1 mm). In two instances cannulae were placed unsuccessfully, where one cannula was too far anterior, the other too far retracted. In this cadaveric simulation study, the feasibility of performing the parasagittal technique for lumbar radiofrequency ablation was evaluated. This study suggests the parasagittal technique is a feasible option for lumbar medial branch radiofrequency ablation.

High‐dose propranolol decreases aggression in young people with autism

As many as two‐thirds of individuals with autism spectrum disorder (ASD) experience challenging symptoms of irritability, including aggression and self‐injury. The antipsychotics risperidone and aripiprazole are approved for the treatment of irritability associated with ASD; however, their adverse effects can compromise long‐term use in many patients. Based on longstanding case reports showing promising results for the beta‐blocker propranolol in reducing challenging symptoms in ASD, investigators conducted a randomized, double‐blind, placebo‐controlled crossover trial to evaluate the feasibility of high‐dose propranolol for treating aggression in patients with ASD. The investigators recruited youths and young adults aged 12 to 30 with ASD and a history of severe and chronic aggression, self‐injury, and disruptive behaviors that interfere with daily activities. Participants were required to have had an inadequate trial of at least two psychotropic medications, including at least one antipsychotic. Dosing of propranolol started at 10 mg three times a day and could be increased until adequate therapeutic response was achieved, to a maximum dose of 200 mg three times a day. Most study visits were conducted via telehealth in order to minimize patient schedule disruption. The primary outcomes were change in scores on the Clinical Global Impression‐Improvement (CGI‐I) and Aberrant Behavior Checklist‐Community (ABC‐C) scales from baseline to study endpoint. Six participants with a mean age of 16 years were enrolled. The investigators found that propranolol resulted in mean reductions of 50% in scores on the CGI‐I and 37% in scores on the ABC‐C. Effect sizes were large for both measures: –0.74 for the CGI‐I and –0.64 for the ABC‐C. “As this was a feasibility pilot study, we had a small sample that limits the generalization of our results to a wider population, and therefore, until a placebo‐controlled, double‐blind study with an adequate number of subjects is conducted, the clinical value of this report is limited,” the study's authors wrote. [London, E., et al. (2024). J Clin Psychopharmacol. https://doi.org/10.1097/JCP.0000000000001895]

Efficacy and safety profile of oral creatine monohydrate in add-on to cognitive-behavioural therapy in depression: An 8-week pilot, double-blind, randomised, placebo-controlled feasibility and exploratory trial in an under-resourced area

Pre-clinical and clinical evidence proposes that creatine monohydrate, an affordable nutraceutical, could be a useful adjunct to conventional antidepressant treatments. In this pilot feasibility and exploratory study, we investigate the 8-week effects of creatine in addition to cognitive-behavioural therapy (CBT) versus placebo plus CBT in depression. For the primary efficacy outcome of change in Patient Health Questionnaire-9 depression score at study endpoint, we used mixed-model repeated measures analysis of covariance. Logistic regressions were employed to assess acceptability (any-cause dropouts), tolerability (dropouts for adverse events), and safety (patients experiencing one or more adverse events). We calculated effect sizes adjusted for age, sex, and baseline depression score. One-hundred participants (50 females, mean age= 30.4 ± 7.4 years) with depression (mean PHQ-9 = 17.6 ± 6.3) were randomised to either creatine+CBT (N = 50) or placebo+CBT (N = 50). At 8 weeks, PHQ-9 scores were lower in both study arms, but significantly more so in participants taking creatine (mean difference= -5.12). Treatment discontinuations due to any cause and to adverse events, and proportion of participants with at least one adverse event were comparable between study arms. This hypothesis-generating trial suggests that creatine could be a useful and safe supplement to CBT for depression. Longer and larger clinical trials are warranted.

A personalised nutrition intervention for adolescent depression: a mixed-methods feasibility pilot study.

Randomised controlled trials have demonstrated the benefit of diet modification to improve diet quality in the treatment of adult major depressive disorder (MDD). However, research examining nutritional interventions for adolescents with MDD is sparse. This pilot study examined the feasibility of a personalised nutrition intervention for adolescents with MDD. Ten adolescents with MDD and their parents recruited from a tertiary care setting participated in an 8-week, single-arm mixed-methods study. Feasibility was assessed using five criteria (demand, acceptability, implementation, adaptation and limited efficacy testing) alongside qualitative interviews. The intervention involved four bi-weekly virtual nutrition counselling sessions with a stepped approach to dietary change, menu planning, grocery delivery and educational eHealth messages. Study participants sought positive changes in diet, health and lifestyle for adolescents and family-wide benefits. Recruitment challenges included concerns about managing mood fluctuations, anticipated dietary restrictions and the potential time and effort required for diet adherence. Feedback based on interviews emphasised moderate to high acceptability, satisfaction with menu planning and counselling and recognition of the benefits of trying new foods and sustaining positive dietary changes beyond the study. Improvements in depression symptoms (Cohen's d = 0·36, 95 % CI (-0·24, 3·36)), parent food modeling (Cohen's d = 0·24, 95 % CI (-0·43, 1·16) and the family food environment (Cohen's d = 0·61, 95 % CI (-0·04, 2·61)) were observed. This nutrition intervention was feasible for adolescents with MDD and was acceptable to both parents and depressed adolescents. These preliminary data suggest that further examination of the intervention and its potential benefits on depression symptoms and family food dynamics are warranted.

Prediction of mental health risk in adolescents via a smartphone app: a feasibility pilot study

Abstract Background The prevalence of mental health problems in adolescents is a global public health concern. Machine learning (ML) can analyse multidimensional data collected by phone sensors (passive tracking) and symptom self-reporting (active tracking) to model and predict mental health states. However, research in adolescents is lacking. This study investigated the feasibility of using ML to predict mental health in a non-clinical population of adolescents from active and passive data collected through the Mindcraft mobile app. Methods We recruited 103 secondary students (aged 14-18) who first completed the Strengths and Difficulties Questionnaire (SDQ) and then used the Mindcraft app for two weeks. The app integrates sensor data (location, steps, noise, light, battery, app usage) and self-reports. We extracted 85 sensor-based features and 19 from questionnaires to develop a gradient-boosted ensemble ML model. This model identifies students with abnormal SDQ scores and was evaluated using leave-one-out cross-validation. Results All students completed the active questionnaires; 67 also provided passive sensor data. 31 had abnormal SDQ scores. Using passive data, the ML model reached a balanced accuracy of 0.64 and an AUC score of 0.57. Incorporating both data types improved accuracy to 0.67 and AUC to 0.70. Feature importance scores showed step count and questionnaire on racing thoughts and hopefulness as most significant. Conclusions Our findings affirm the potential of integrating passive and active data collection to monitor mental health in real-world settings. Our ML model demonstrated moderate accuracy in predicting adolescents’ mental health risk measured with a behavioural screening questionnaire. This study will guide the development of a ML-driven, personalised mobile intervention for early symptom detection and mental health self-management, which might constitute an innovative and scalable tool for mental health prevention and intervention in adolescents. Key messages • This study shows the feasibility of using active and passive data to predict mental health risk in adolescents. • This study informs the development of a personalised machine learning-driven mobile intervention.

Identification of premature cardiovascular disease using a family-based strategy: a feasibility pilot study

Abstract Background Current guidelines fail to identify and effectively prevent cardiovascular disease (CVD) in young adults. Purpose To assess the feasibility of a systematic cardiovascular risk assessment in first-degree relatives of individuals with premature coronary artery disease (CAD). Method Index patients with obstructive CAD aged ≤ 45 years or ≤ 55 years without standard modifiable cardiovascular risk factor or ≤ 55 years with a 3-vessel coronary disease were prospectively identified among admissions. Pre-existing cases of CVD and prior cardiovascular check-ups were assessed among their first-degree relatives. Siblings and adult-children (≥25 years) without known CVD or active cardiology follow-up were eligible for a first cardiovascular evaluation. Index patients were encouraged to invite their eligible relatives to contact the Cardiology service for consultation. The primary endpoint was the relative’s eligibility for a cardiovascular prevention consultation. Result From September 2022 to June 2023, 137 patients with premature CAD, with 55.5% aged ≤ 45, were invited to initiate cardiovascular screening among their first-degree relatives. Of the 626 identified relatives, 153 (24.4%) had known atherosclerotic disease, primarily CAD (19.6%). Premature onset (before the age of 45) occurred in 5% of first-degree relatives. Among the 352 siblings and adult-children, 48 (13.6%) were already diagnosed with CVD, 68 (19.3%) were treated or followed for primary prevention, and 226 (64.2%) lacked active cardiovascular monitoring or treatment and were eligible for a first cardiovascular check-up (Figure 1). Within 10 months, 11.1% (25/226) of eligible relatives attended a first cardiovascular evaluation. Conclusion This family-based screening strategy for premature CVD demonstrated 1) a significant familial dimension, with 33% of siblings &amp; adult-children already monitored for CVD prevention, and 2) an opportunity for cardiovascular prevention in two out of three young relatives.

Challenges in performing a structured follow-up in Swedish nursing home residents after stroke: a pilot feasibility study

Multidisciplinary team-based follow-ups are recommended for all stroke patients in Sweden including those discharged to nursing homes. We aimed to explore the feasibility of a structured follow-up with the Post Stroke Checklist (PSC) in nursing home residents, and to map stroke related problems and planned interventions. Due to a complex recruitment process and low recruitment rate, the study protocol was adapted to an explorative design. Nine health professionals and five nursing home residents participated. The health professionals were generally satisfied with the PSC. Many stroke related problems were identified, and several inexpensive ongoing or planned interventions were considered. However, several obstacles for performing a routine structured stroke follow-up were identified, such as lack of coordination between different stakeholders, fear of increased paperwork and lack of referral options for some of the suggested interventions, indicating that there is a need to build up a suitable organization able to take action for the identified problems. Various hinders performing the study itself were also identified. Difficulties in recruiting physically and mentally frail participants in studies might lead to an inadequate basis for decision-making, hindering people with extensive disabilities to receive scientifically based interventions.

Feasibility of Monitoring Heart and Respiratory Rates Using Nonwearable Devices and Consistency of the Measured Parameters: Pilot Feasibility Study.

As Japan is the world's fastest-aging society with a declining population, it is challenging to secure human resources for care providers. Therefore, the Japanese government is promoting digital transformation and the use of nursing care equipment, including nonwearable devices that monitor heart and respiratory rates. However, the feasibility of monitoring heart and respiratory rates with nonwearable devices and the consistency of the rates measured have not been reported. In this study, we focused on a sheet-type nonwearable device (Safety Sheep Sensor) introduced in many nursing homes. We evaluated the feasibility of monitoring heart rate (HR) and respiratory rate (RR) continuously using nonwearable devices and the consistency of the HR and RR measured. A sheet-type nonwearable device that measured HR and RR every minute through body vibrations was placed under the mattress of each participant. The participants in study 1 were healthy individuals aged 20-60 years (n=21), while those in study 2 were older adults living in multidwelling houses and required nursing care (n=20). The HR was measured using standard methods by the nurse and using the wearable device (Silmee Bar-type Lite sensor), and RR was measured by the nurse. The primary outcome was the mean difference in HR and RR between nonwearable devices and standard methods. The mean difference in HR was -0.32 (SD 3.12) in study 1 and 0.04 (SD: 3.98) in study 2; both the differences were within the predefined accepted discrepancies (<5 beats/min). The mean difference in RR was -0.98 (SD 3.01) in study 1 and -0.49 (SD 2.40) in study 2; both the differences were within the predefined accepted discrepancies (3 breaths/min). HR and RR measurements obtained using the nonwearable devices and the standard method were similar. Continuous monitoring of vital signs using nonwearable devices can aid in the early detection of abnormal conditions in older people.

STORMS: A Pilot Feasibility Study for Occupational TeleRehabilitation in Multiple Sclerosis.

Digital solutions in the field of restorative neurology offer significant assistance, enabling patients to engage in rehabilitation activities remotely. This research introduces ReMoVES, an Internet of Medical Things (IoMT) system delivering telemedicine services specifically tailored for multiple sclerosis rehabilitation, within the overarching framework of the STORMS project. The ReMoVES platform facilitates the provision of a rehabilitative exercise protocol, seamlessly integrated into the Individual Rehabilitation Project, curated by a multidimensional medical team operating remotely. This manuscript delves into the second phase of the STORMS pilot feasibility study, elucidating the technology employed, the outcomes achieved, and the practical, professional, and academic implications. The STORMS initiative, as the genesis of digital telerehabilitation solutions, aims to enhance the quality of life for multiple sclerosis patients.

Bedside 3D ultrasound fistula maturation assessment by non-expert sonographers provides equivalent accuracy to formal duplex sonography: A prospective clinical trial.

EchoSure is an automated point-of-care 3D ultrasound (3DUS) designed to be used by dialysis technicians without advanced ultrasound training. The EchoMark/EchoSure System is a two-part system comprised of a bioresorbable implant, EchoMark, and a diagnostic ultrasound imaging platform, EchoSure. EchoSure was designed to enable any healthcare personnel in a dialysis clinic setting to obtain non-invasive, direct measurements of flow and vessel parameters that are critical quantifications used in the assessment of AVF maturation and readiness for hemodialysis cannulation. In this pilot feasibility study, we sought to explore whether use of an automated 3DUS could enable fistula assessment by non-experts and obtain measurement accuracy comparable to expert sonographer Duplex. This was a 20 subject prospective multicenter trial conducted at four sites in the United States. All subjects had an EchoMark implanted under their AVF during the fistula creation procedure. Subjects were evaluated at 2-weeks post-op with EchoSure and Duplex, followed by monthly assessments until either the 4-month visit or until radiographic maturation was achieved, whichever was longer. Beyond monthly ultrasound assessments, clinical follow-up continued every 6 months between months 6 and 24. Technical success of EchoMark implantation was demonstrated in 100% of subjects. Technical success of EchoSure was 99% across all scans. The mean percent difference in flow rate measurements between EchoSure and Duplex was -9.2% with a standard deviation of 38.1% compared to a mean percent difference of -15.7% with a standard deviation of 35.5% between Duplex measurements taken at the cannulation zone and brachial artery. Pearson correlation between EchoSure and Duplex was 0.708 versus 0.716 for the two Duplex measurements. Radiographic maturation was achieved in 70% of study subjects by 30 days and continued to rise to 90% through 90 days and 95% through 180 days after baseline. This study demonstrates the feasibility and accuracy of an automated 3D ultrasound system for assessment of maturation at the dialysis bedside by non sonographers.

A Pilot Feasibility Study of Delivering a Quit & Win Tobacco-Free Contest in Community Mental Health Programs.

Quit & Win contests are a community-based tobacco cessation strategy that has demonstrated success in supporting tobacco cessation efforts in the general population. However, such contests have not been implemented and evaluated among people living with mental illnesses (MIs). This pilot study aimed to evaluate the feasibility of implementing Quit & Win contests in terms of program delivery, engagement, and cessation outcomes among people with MIs. A single-group posttest design to evaluate the feasibility of Quit & Win contests conducted at three community mental health programs. Flyers introducing the contest were posted at study sites 2 weeks prior to recruitment. Recruitment occurred on 2 days over a 2-week period. Eligible participants received a pamphlet with information about tobacco treatment resources. At the follow-up, postsurveys and expired CO levels were obtained. Participants (N = 28) were mostly male, Non-Hispanic White, with a high school or higher education, unemployed, and 46.4% had a primary substance use disorder diagnosis. Among those who engaged in the program, seven (25.0%) returned for the follow-up, of which three (42.9%) successfully stopped cigarette use. Four (57.1%) described using nicotine replacement therapy in their attempt to stop using cigarettes. Challenges to cessation included difficulty finding available tobacco treatment programs, limited access to treatment medications, and experiencing nicotine withdrawal symptoms. Our findings suggest the feasibility of Quit & Win interventions in community mental health settings. Further efforts are required to enhance recruitment, engagement, and retention, and to support access to community-based tobacco treatment resources.

Longitudinal Pupillary Light Reflex testing as an aid to monitor recovery in Sport Related Concussion – a pilot feasibility study

Longitudinal Pupillary Light Reflex testing as an aid to monitor recovery in Sport Related Concussion – a pilot feasibility study

Novel reopenable clip with anchor prongs facilitates mucosal defect closure after colorectal endoscopic submucosal dissection: Pilot feasibility study (with video).

Closure of mucosal defects following colorectal endoscopic submucosal dissection (C-ESD) is often performed to prevent post-C-ESD adverse events. However, large mucosal defect closure using conventional clips remains technically challenging. Here, we evaluated the feasibility of the novel endoclip with anchor prongs, called the MANTIS Clip (Boston Scientific, Tokyo, Japan), for mucosal defect closure after C-ESD. This high-volume retrospective study was conducted at a single center. From March until December 2023, consecutive patients who underwent post-C-ESD mucosal defect closure using MANTIS Clip to achieve complete closure were enrolled. Patient clinical characteristics and outcomes were evaluated. Closure of the mucosal defect using the MANTIS Clip was attempted following C-ESD in 32 lesions. The median sizes of the resection specimens and the tumors were 32 mm (range, 17-100 mm) and 23.5 mm (range, 5-96 mm), respectively. The lesions were distributed between the cecum, ascending, transverse, descending, sigmoid, and rectum. Complete closure was achieved in 96.9% of cases (31/32). All lesions up to 61 mm in defect size were completely closed. The median closure time was 7.9 (range, 3.3-18.0) min. The median numbers of MANTIS Clip and additional conventional clips were 3 (range, 1-4) and 5 (range, 1-11), respectively. No adverse events associated with closure, post-ESD bleeding, and delayed perforation occurred. MANTIS Clip closure for large post-C-ESD mucosal defects was found to be feasible and reliable with a high complete closure rate and a short procedure time.

S1761 Virtual Reality Application in Hospitalized Patients With Decompensated Cirrhosis: A Feasibility Pilot Study

S1761 Virtual Reality Application in Hospitalized Patients With Decompensated Cirrhosis: A Feasibility Pilot Study

13 - Pilot Feasibility Study of a Mobile App Supporting Self-Management of Fecal Incontinence

13 - Pilot Feasibility Study of a Mobile App Supporting Self-Management of Fecal Incontinence

Patient engagement in a community-partnered hybrid health-related social needs navigation intervention for adolescents and young adults with cancer (AYA-NAV).

173 Background: Adolescent and young adult (AYAs) cancer survivors experience high rates of financial toxicity (FT), which is associated with poorer health outcomes. FT may disproportionately affect AYAs with unmet health-related social needs (HRSN), such as food or housing insecurity. Needs navigation may be an effective intervention to reduce financial distress, however, engagement has been a challenge in prior adult-directed interventions. We hypothesize that a hybrid navigation delivery model with community organization support and digital delivery will reduce financial distress and improve health outcomes. In a pilot study of AYA-NAV, an AYA-directed needs navigation intervention, we report patient engagement among participants. Methods: Eligible AYAs were 15-39 years old, Spanish- or English-speaking, receiving curative-intent treatment for cancer, and screened positive for FT (Comprehensive Score of Financial Toxicity &lt; 22) or unmet HRSN (food, housing, transportation, or utilities insecurity). Participants were referred for a consultation with the Patient Advocate Foundation (PAF), a national organization that provides case management and navigation support for people facing life limiting illness. At month 1, participants were referred to findhelp.org, a digital platform of comprehensive resources to facilitate resolution of unmet HRSN. Monthly check-ins were conducted by the study team to assess acceptability, intervention fidelity, and provide additional navigation support. We plan to enroll 30 participants on this study. Results: Of 19 AYAs that completed screening to date, 13 met criteria for FT or unmet HRSN; 13 (100%) agreed to AYA-NAV participation. To date, of 46 check-ins initiated by the study team, 33 (72%) were completed. All AYAs connected with the study team at least once during the 6-month duration of the study by text, phone, and/or in-clinic. Ten out of 13 (77%) participants reported that they spoke with a PAF case manager, and 7 (70%) of those said it was helpful. If the patient was unable to connect with PAF, more than half (55%) requested to be reconnected during a monthly check-in. Eight of the 13 (62%) participants visited findhelp.org; 6 (75%) of those found the digital platform to be helpful. Most patients referenced the high usability of findhelp.org, and 55% stated they connected to community resources via findhelp.org. Patients qualitatively reported challenges to intervention participation including medical complications, scheduling conflicts, and work commitments. Conclusions: Preliminary data demonstrate high patient engagement and intervention fidelity during a pilot feasibility study of AYA-NAV. Flexible modes for data collection and intervention delivery are important to inclusion of and retention of AYAs in hybrid navigation delivery models. Clinical trial information: NCT06072833 .

Digital behaviour change intervention for weight loss maintenance in adults with obesity: a feasibility pilot study of eCHANGE

ABSTRACT Successful weight maintenance after weight loss is challenging. Digital interventions may facilitate behaviour change to prevent weight regain, however little is known about the acceptance and use of digital interventions in support of weight maintenance. This mixed methods study aims to evaluate user experiences, system use, and preliminary efficacy of eCHANGE, an application based self-management intervention for weight loss maintenance. A 3-month multi-site single group feasibility pilot study was conducted among adults (N = 60) with BMI ≥30 kg/m2, aiming to maintain weight after weight loss of ≥8%. User experiences and system use were examined through validated questionnaires, system use log data, and individual interviews (n = 15). Preliminary efficacy testing included body weight and patient reported outcome measures. Participants rated eCHANGE usability and usefulness as good in support of weight maintenance, with variation in usage. Analysis indicated that higher behavioural engagement scores were statistically significantly associated with frequency of technology usage. Weight loss was maintained by 83% of the participants at 3-months (i.e. defined as weight change of <3% of baseline body weight (kg)). Digital interventions, combining persuasive system design principles and behaviour change techniques, supporting self-regulation and maintenance of health behaviours, have the potential to facilitate weight maintenance after weight loss. Trial Registration: ClinicalTrials.gov NCT04537988 https://clinicaltrials.gov/ct2/show/NCT04537988