Pilot and Feasibility Studies最新文献

Introduction: This paper reports on the first two phases of a three-phase project to develop and evaluate an "integrated" iteration of ENabling VISions And Growing Expectations (ENVISAGE). ENVISAGE is a validated online 5-week program grounded in strengths-based and family-centred approaches to child and family development in the context of neurodevelopmental disability. The two phases included (i) partnership formation and collaborative adaptation of the ENVISAGE programs for families (ENVISAGE-Families) and for service providers (ENVISAGE-SP) to create an "integrated" approach; and (ii) conduction of a feasibility study.

Methods: ENVISAGE-Integrated was co-developed through an iterative process of revising and combining the original ENVISAGE programs (for families and for service providers). The Framework for Reporting Adaptations and Modification-Expanded (FRAME) was used to report modifications. The feasibility study included 12 participants (7 service providers and 5 parents) from a children's treatment centre. Participants completed a demographic questionnaire and surveys after each workshop, including open-ended and 5-point Likert-scaled questions about their experiences of the program. All data were analyzed descriptively.

Results: Program modifications were undertaken to ensure relevance to both service providers and parents and to preserve the core ENVISAGE concepts. Key modifications included (i) incorporating weekly icebreaker activities and (ii) tailoring current and creating additional scenarios to prompt discussion and apply concepts. Participants found the integrated format was valuable, meaningful, and relevant. Challenges included recruiting participants and scheduling synchronous group discussions.

Conclusion: Participants' feedback informed two program adaptations: (i) allotting more time to apply concepts to scenarios during group discussions and (ii) supporting the use of the platform's discussion board. The findings from the feasibility study justify the ongoing development and evaluation of program outcomes on both service providers and parents.

Background: Few United States youth meet physical activity (PA) guidelines, with notable gender, racial/ethnic, and geographic disparities. Sport is one of the best strategies for increasing PA levels, yet girls drop out at a higher rate than boys, and both rural and Hispanic girls participate in lower numbers than their counterparts. Physical literacy (lifelong ability to move) and sport sampling (multiple sport engagement) are core elements of healthy youth sport participation. Commonly cited barriers to starting and/or sustaining sport participation include lack of competence (feeling capable), autonomy (feeling independent), and relatedness (feeling connected to others), in line with self-determination theory (SDT). Unique cultural factors also influence PA and sports participation among Hispanic girls. The proposed research aims to determine the feasibility of an out-of-school sport sampling and physical literacy intervention (Girls PLAY) on rural, Hispanic girls' PA levels.

Methods: For Aim 1, we will conduct qualitative interviews (n = 37) with rural-dwelling girls, parents, coaches, and program staff to identify sport participation determinants for rural, Hispanic girls and use these findings to inform Girls PLAY program development. For Aim 2, we will optimize the program using human-centered design (HCD) strategies such as live prototyping. Staff will implement the program for 2 weeks at a time to a program site, with feedback collected via direct observation and interviews. Feedback will inform additional program modifications. For Aim 3, we will determine the feasibility of the modified program. Staff will deliver the Girls PLAY program using SDT-based instruction at two out-of-school programs. In a sample of thirty girls, we will examine feasibility (recruitment, assessments completed, acceptability, appropriateness, attendance) and pre-post changes in PA, physical literacy, and sport participation, as well as theorized program mediators of SDT constructs.

Discussion: This study's innovative use of HCD strategies will help culturally tailor the Girls PLAY intervention components and ground this work in knowledge about the rural, predominantly Hispanic border populations and the contexts in which it will be delivered. This work is significant in that addressing barriers to physical activity and sport via an out-of-school program can reduce gender, racial, and geographic disparities in youth activity levels.

Trial registration: ClinicalTrials.gov, NCT06229457, registered January 11, 2024, https://clinicaltrials.gov/study/NCT06229457.

Background: Chronic musculoskeletal pain and overweight/obesity are comorbid conditions that negatively impact each other, yet interventions targeting this comorbidity are limited. This study evaluated the feasibility and acceptability of an integrated weight and pain management intervention that uniquely targets environmental reward processes and positive affect.

Methods: Participants (45-80 years) with comorbid overweight/obesity (BMI ≥ 25 kg/m²) and moderate-to-high impact musculoskeletal pain participated in a single-arm trial of a remotely delivered intervention integrating behavioral weight loss treatment and cognitive-behavioral pain coping therapy addressing mechanisms of environmental reward and positive affect. Assessments of weight, pain (via PROMIS pain intensity, interference, and physical function scales; Short Physical Performance Battery), and process variables were completed at baseline, 4 months (end of core intervention phase), and 8 months (end of elective intervention phase). Recruitment and retention metrics and patient satisfaction ratings were measured.

Results: Thirty-three patients enrolled in the trial. Of these, 76% (n = 25) completed the core intervention and 79% (n = 26) completed the 4-month assessment. Results indicated high credibility (7.8/10) and session engagement (6.7/8), and global treatment satisfaction (3.6/4) was high. At 4 months, pain impact decreased by 4.0 points from pre- to post-intervention and mean weight loss was 2.4% of baseline body weight, with n = 4 participants (15.4%) achieving ≥ 5% weight loss. Of the 19 participants who completed the elective phase, pain impact decreased from baseline by 6.6 points and mean weight loss percent from baseline was 3.0%.

Conclusions: Overall, this pilot study demonstrated that a remotely delivered weight loss plus pain reduction intervention is feasible and was well accepted by participants with overweight/obesity and comorbid pain. The intervention produced reductions in pain and weight, supporting further testing in a fully powered clinical trial.

Trial registration: This trial is registered in ClinicalTrials.gov (NCT04851587).

Background: Recovery-promoting drugs (RPDs) offer a pharmacological approach to improve motor recovery in stroke survivors. Investigating stroke survivors' preferences for taking RPDs would allow preferences to be considered during development of intervention protocols and optimise participant adherence. The aim of this study was to develop and pilot a robust discrete choice experiment (DCE) that examines stroke survivors' preferences for RPDs in combination with physical training to improve motor recovery. Pilot objectives were to assess the: (1) effectiveness of the data collection strategy; (2) effectiveness of the survey instrument design; and (3) robustness of the discrete choice experiment design.

Methods: An online DCE with two-alternative choice tasks consisting of six attributes (efficacy, out-of-pocket cost, side effects, treatment duration, dosage, and risk) depicting a stroke rehabilitation program involving RPDs. Respondents completed eleven choice tasks each: nine choice tasks divided into four blocks, plus a dominant choice and duplicate task. Participants were community-dwelling Australian stroke survivors. Outcomes included measures of data completeness, choice validity, and content validity. Conditional logit model analysis was used to estimate the marginal willingness-to-pay, and β coefficients for attributes and levels.

Results: Seventy-three stroke survivors completed the online DCE, with a survey completion rate of 89%. The survey instrument design was effective, with 94.5% and 84.9% respondents passing the dominant and duplicate choice tasks respectively. The DCE design was robust with clear and appropriate attributes and levels, accurate choice tasks and experimental design.

Conclusions: Systematic development and piloting of this DCE has confirmed its robustness and feasibility. This study provides an example of robust procedures and reporting requirements for developing and piloting robust discrete choice experiments.

Background: People with cancer who have limited English proficiency (LEP) are at high risk for poor mental health outcomes in survivorship as they face cultural, linguistic, and mobility-related barriers to accessing psychosocial care. Telemental health interventions can be of great utility because they can decrease participation burden and are cost-effective. Patients with LEP who receive telemental health services primarily access them through remote interpretation due to a shortage of bilingual therapists. Remote interpreting can be: (1) simultaneous (rarely used in medical settings) or consecutive (usual care in medical settings). Prior research has found that Remote Simultaneous Medical Interpreting (RSMI) resulted in fewer errors, better medical outcomes, and higher patient satisfaction than consecutive methods in oncology and primary care settings. Yet, RSMI has not been studied in the context of a counseling/psychotherapy encounter. INTERPRET-PSY is a mixed method, 3-arm pilot randomized controlled trial (RCT) designed to determine if RSMI is feasible and acceptable in comparison to usual care (RCMI) and "gold standard" care (bilingual provider) in delivering counseling/psychotherapy to Mandarin-speaking LEP cancer patients.

Methods: A total of 45 participants will be randomly assigned to one of 3 arms (n = 15 RCMI, n = 15 RSMI, and n = 15 bilingual provider) to receive 6 counseling/psychotherapy sessions. Feasibility and acceptability of the interpreting modalities (RCMI, RSMI) will be evaluated through self-report assessments. Secondary outcomes will include therapeutic alliance, MCP-Ch content comprehension, and clinically significant interpreting errors across the interpreting (RCMI, RSMI) arms. Semi-structured interviews with a purposively sampled subset of patients, their interventionists, and interpreters (if applicable) across all 3 arms will assess potential barriers and facilitators to successful interpreter-mediated communication and outcomes.

Discussion: INTERPRET-PSY is the first study to examine the feasibility and acceptability of delivering a culturally adapted, evidence-based, and telehealth-delivered counseling/psychotherapy intervention to cancer patients with LEP via RCMI and RSMI. Results of the pilot RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application for a fully powered RCT of interpreting modalities in the provision of linguistically accessible and culturally appropriate psycho-oncology care.

Trial registration: NCT02112188.

Background: Adolescents and young adults (AYAs) with cancer experience deficits in social connection that persist into survivorship; currently, few interventions target this unmet need. The current article describes the protocol for a pilot, parallel-group randomized controlled trial of a psychosocial intervention [Promoting Resilience in Stress Management (PRISM)] that includes a new skill-based module targeting AYA social needs (SN). The aims are to (1) establish the feasibility and acceptability of the PRISM-SN-adapted program; and (2) demonstrate proof-of-concept via clinically meaningful improvements in patient-reported outcomes (PROs).

Methods: We anticipate 70 AYAs will enroll and complete data collection at two sites: Seattle Children's Hospital and UPMC Children's Hospital of Pittsburgh. Eligible AYAs are ages 12-25 years old; diagnosed with a new malignancy < 6 months; treatment plan includes chemotherapy and/or radiation; and are English-speaking. Enrolled AYAs are randomized 1:1 to receive PRISM-SN or usual care and complete surveys at baseline and 12-week follow-up. PRISM-SN includes 5 sessions (4 standard PRISM modules + new SN module) teaching behavioral skills associated with psychosocial wellbeing. Sessions are delivered 1:1 by a trained coach, in person or virtually, 1-2 weeks apart. Feasibility will be defined based on uptake, retention, and patient-reported intervention acceptability. Proof-of-concept will be defined based on clinically meaningful change and detectable differences in PROs at 12 weeks, including social relationship coping efficacy (primary PRO of interest), social support, quality of life, resilience, anxiety, depression, and hope. Descriptive statistics and covariate-adjusted regression models will be used to assess feasibility outcomes and examine trends and between-group differences in PROs across study arms.

Discussion: This pilot trial will determine feasibility of PRISM-SN in the context of a multi-site trial; provide proof-of-concept via effects of PRISM-SN on social connection outcomes; and represent an important step toward addressing an unmet need in AYA cancer care. Future directions include testing efficacy and effectiveness via larger multicenter trials.

Trial registration: ClinicalTrials.gov Identifier NCT06242964.

Background: The Spinal Cord Injury and You (SCI&U) intervention aims to improve self-management skills for persons living with SCI using a web-based, peer health-coaching model. This study assessed feasibility of a future definitive trial of SCI&U, specifically feasibility of recruitment and retention, program usability and quality, effect size estimates for self-management outcomes and rehospitalisation rates (i.e. health-related quality of life).

Methods: A two-group, randomised, controlled, pilot trial with prospective recruitment, concealed group allocation, blinded outcome evaluation and waitlist control was conducted. We aimed to recruit 60 adult participants living in the community at least 6 months post-injury who could speak and read English and had a family physician. The intervention included up to 14 1-h online client-coach videoconferencing sessions, goal setting, action planning and a sortable resource library. Data were collected at baseline, 2, 6 and 12 months post-randomisation. SCI&U was offered to waitlist participants at 12 months.

Results: Trial methodology and procedures were feasible. Recruitment and retention targets were achieved. Individuals were randomised to intervention (n = 31) and waitlist control (n = 34). Mean time since SCI was 25.6 years (intervention) and 20.2 years (control). Timeline for completion of online sessions was extended from 2 months to 6 months. Outcome data were gathered for 86% (6 months) and 89% (12 months) of participants. Program usability and quality were highly rated on the Mobile App Rating Scale. Difference in Skill and Technique Acquisition subscale between intervention and control was 0.56 (95%CI -0.41, 1.52) at 6 months and 0.72 (95%CI -0.28, 1.72) at 12 months. Other Health Education Impact Questionnaire subscales had large effect sizes: self-monitoring and insight 1.51 (95% CI 0.39, 2.69); emotional distress -1.40 (95%CI -3.04, 0.23). In 12 months post-recruitment, 5 intervention and 4 control participants spent median 11 (95% CI 3-19) and 24 (95% CI 5-95) nights in hospital, respectively.

Conclusions: Trial methodology and procedures were feasible. The SCI&U intervention was acceptable to participants and positively impacted an individual's ability to self-manage. A definitive trial is warranted to build on these findings, particularly in those with recently acquired SCI. Future recruitment efforts will focus on inpatient rehabilitation hospitals to recruit individuals < 5 years post-injury.

Trial registration: ClinicalTrials.gov, NCT04474171, retrospectively registered 07/13/2020; https://clinicaltrials.gov/study/NCT04474171#study-record-dates .

Background: Fruit and vegetable gardening (herein referred to as gardening) is positively associated with two behavioral risk factors for cardiovascular disease (CVD), diet and physical activity. Since gardeners often report enjoying the activity, an intervention that fosters enjoyment (i.e., intrinsic motivation) in those interested could be a promising health promotion strategy. This study assessed the feasibility of Growing Healthy Hearts, a multicomponent gardening, cooking, and the Dietary Approaches to Stop Hypertension (DASH) intervention for adults with CVD risk.

Methods: Using a 2-arm, parallel-group, pilot randomized controlled trial design, we conducted a 24-week intervention with 10 videoconference sessions and a private Facebook group. Content targeted gardening and cooking skills, nutrition knowledge, intrinsic motivation, and social support. Participants (aged 20 +) were randomized to the intervention or a no treatment control if they had low fruit and vegetable intake (< 5 servings/day), low physical activity (< 150 min/week), and ≥ 1 CVD risk factor. Feasibility was defined as acceptability (mean score on a 5-point scale), recruitment rates, retention, and treatment adherence (completion of 10 gardening tasks). Linear mixed-effects models evaluated changes from baseline to 24 weeks in fruit and vegetable intake, cooking, intrinsic motivation, and steps/day.

Results: Forty participants were randomized within 3 months (20/group). They had a mean age of 48 years (SD 12) and were primarily white (n = 29, 73%) or African American (n = 6, 15%), and female (n = 34, 85%). All feasibility targets were met. The majority (90%, n = 36) completed the 24-week follow-up. The mean acceptability score was 4.8 (SD 0.34) and treatment adherence was high with 94.7% (18/19) of intervention participants starting a garden and completing a mean of 9.5 out of 10 gardening tasks (SD 0.48). Comparing changes from baseline to follow-up, the intervention group had higher fruit and vegetable intake (+ 0.94 cups/day, 95% CI: [0.08, 1.79]), steps/day (+ 1,029/day, 95% CI: [567, 1493]), and intrinsic motivation (+ 1.0, 95% CI: [0.34, 1.66]).

Conclusions: The intervention was feasible and exploratory analyses revealed improvements in fruit and vegetable intake, steps/day, and intrinsic motivation. The next step is to test the efficacy and sustainability of the intervention effects in a well-powered efficacy trial.

Clinical trial registration: Registered on Clinicaltrials.gov (NCT05720611). Registered on January 13, 2023, https://clinicaltrials.gov/study/NCT05720611?term=nct05720611&rank=1 .

Background: Problem Management Plus (PM +) is a low-intensity psychological intervention developed by the World Health Organization to reduce psychological distress, particularly in settings with limited access to mental health care. To date, PM + has not been culturally adapted for the Xhosa community in South Africa, nor has it been evaluated in a massed format (five daily sessions delivered within 1 week). This study aims to culturally adapt PM + for the Xhosa context and to assess the feasibility and acceptability of a massed delivery format.

Methods: The study will be conducted in three phases. Phase 1 will involve qualitative semi-structured interviews with key stakeholders and health professionals from the Xhosa community to inform the cultural adaptation of PM +. Phase 2 will consist of a pilot randomised controlled trial (N = 60) with participants experiencing psychological distress recruited at an Non-Profit Organisation (NPO) called Sakhe Family Care Development Centre in Kwa-Nomzamo, Humansdorp. Participants will be randomised to receive either (a) PM + (n = 30) or (b) care-as-usual only (n = 30). As this pilot is not powered to detect effectiveness, analyses will be exploratory and aimed at assessing feasibility, acceptability, and implementation potential. Phase 3 will comprise a qualitative process evaluation with PM + participants, PM + helpers, and key stakeholders.

Discussion: The findings will identify barriers and facilitators to delivering PM + in a massed format and provide preliminary insights to guide iterative adaptations and future fully powered trials of effectiveness and cost-effectiveness in South Africa.

Trial registration: Pan African Clinical Trials Registry, PACTR202110484536189. Registered retrospectively on 25 October 2021.

Background: Malnutrition is prevalent in older hip fracture patients and increases the risk of postoperative complications and loss of physical function. Adequate energy and protein intake during rehabilitation can enhance recovery but treatment can be challenging. The primary objective was to assess feasibility, defined as eligibility, recruitment rate, retention in the study, compliance to the intervention and completeness of outcome data collection.

Methods: This single-site, open labelled, parallel, two-arm randomized controlled feasibility trial took place at Orthopaedic Surgical ward at Herlev Hospital, Denmark. Participants were ≥ 65 years at nutritional risk admitted with a hip fracture. The intervention group received two bottles of oral nutritional supplements daily for 12 weeks after discharge. The control group received standard care.

Results: Of 134 patients screened, 52 (39%) met inclusion criteria and 21 (40%) were recruited, corresponding to 2.3 participants per week. Preliminary findings showed a retention rate of 16 out of 21 (76%). Compliance to the oral nutritional supplements was 62% reflecting an intake of 1.3 oral nutritional supplementation per day. Data collection was high, with ≥ 80% completeness for most outcomes (handgrip strength, calf circumference, frailty, quality of life, activities of daily living, 24-h recall, blood measures), except for the baseline 30-s chair-stand test.

Conclusion: The trial methods were feasible with sufficient eligibility, recruitment rate, retention in the study and outcome data collection. Compliance was lower than expected highlighting the need for strategies to improve adherence in the definitive trial.

Trials registration: ClinicalTrials.gov identifier: NCT05556876. Date of registration: 2022.23.09. URL: https://clinicaltrials.gov/study/NCT05556876 .