Pilot and Feasibility Studies最新文献

Background: The development of pre-operative interventions to improve clinical outcomes following total knee replacement surgery has been identified as a research priority. In the first step of a programme of research, we conducted a feasibility cohort study, which investigated the effect of modifiable lifestyle factors, including alcohol consumption, smoking, physical inactivity and living with overweight, on clinical outcomes following total knee replacement (PRO Knee). Alongside PRO Knee, we conducted an integrated qualitative study to understand the acceptability of the methods used in the PRO Knee study and to explore the experiences of patients waiting for total knee replacement surgery, along with their beliefs and experiences regarding lifestyle interventions.

Methods: Adult patients awaiting total knee replacement surgery, who had consented to participate in the PRO Knee study were eligible to participate. Semi structured interviews were conducted with all patients who provided informed consent for the qualitative study. Interviews were audio-recorded; transcribed in an intelligent verbatim format and data were analysed using the Framework Method.

Results: Ten participants (9 female, 1 male) were recruited (average age 70, range 56-88) and all interviews were conducted over the telephone. The recruitment and data collection processes of the PRO Knee study were acceptable to participants. Five further themes relating to the lived experience of waiting for and undergoing total knee replacement surgery were identified: 1) Osteoarthritis of the knee and co-morbidity; 2) The decision to have surgery; 3) Waiting for total knee replacement; 4) Lifestyle conversations and interventions; 5) Recovery from total knee replacement. The burden of living with osteoarthritis of the knee was significant and participants had often experienced multiple unsuccessful interventions. Participants could recall lifestyle conversations, which they were open to, but were not offered support. Most participants were positive about participating in lifestyle interventions prior to surgery. The participants who had poor outcomes were left with intrusive pain, and feelings of regret.

Conclusion: The recruitment and data collection processes for the PRO-Knee feasibility cohort study were acceptable to participants and further study in this area is now warranted.

Background: Canadian adolescents report poor dietary quality. Smartphone-based nutrition interventions have the potential to improve adolescent diets through food knowledge and purchasing. "SmartAPPetite for Youth" is a smartphone-based nutrition intervention for adolescents that addresses key gaps in the literature. The study objective is to evaluate the intervention for feasibility, acceptability, and usability before undertaking a full-scale randomized controlled study.

Methods: The study was conducted in March-June 2016, among adolescents aged 14 years attending a secondary school in London, Ontario. Participants received the SmartAPPetite application on their phones, which sent time-based healthy eating messages (max 3/day) and location-based "nudge" messages (max 5/day) for 8 weeks. To evaluate recruitment methods, performance of app features, suitability of study instruments, and overall feasibility (measured by the rate of study retention, with a target of 70%), data was collected via the following: (1) a pre-post youth survey; (2) assessing participant experience; and (3) researcher observations. The youth survey included demographic questions, and questions about nutrition perceptions, food intake behaviors, food knowledge, and food purchasing behaviors. Questions about participant experiences included how often they interacted with the app, what they liked, and what they thought should be improved.

Results: Of 108 eligible adolescents, 59 consented to participate and 54 completed the follow-up survey. Most participants reported that the app benefitted them and stated that they would recommend the app to a friend. Results from the youth survey show that SmartAPPetite has the potential to influence food knowledge, food purchasing, and food intake behaviors. The implementation review identified some changes to our intervention study design, tools, and the app that are required for it to have the greatest impact in a scaled-up scientifically rigorous randomized controlled study.

Conclusions: The results of this pilot study show that the project is feasible, and that adolescents will accept the intervention and enjoy engaging with the app. The app was well accepted, and participants perceived that it was helpful in improving their food knowledge and health behaviors. The primary objective of this study identified some key lessons that can be built upon for a larger study. The impact of the app needs to be properly tested in a full-scale trial.

Background: Social anxiety is prevalent amongst university students. Cognitive-behaviour therapy (CBT), and graded exposure techniques in particular, is an effective intervention for social anxiety. However, there are a number of barriers preventing the delivery of CBT to students who are socially anxious. Delivering this intervention using virtual reality (VR) can address these implementation issues. We have co-developed with a group of students a VR-CBT intervention (UniVRse) specifically for members of this student group with social anxiety.

Methods/design: The present study is a pilot randomised controlled trial conducted in the United Kingdom of the UniVRse intervention compared to a wait-list control group. The aim of the trial is to determine whether a definitive trial is justified by assessing study recruitment, retention, and acceptability, as well as establishing the effect size on the co-primary outcomes for the definitive trial sample size calculation. We aim to recruit 90 socially anxious students-45 in each trial arm. The trial will adopt a mixed-methods approach. We will collect quantitative data at baseline (T0) and post-intervention 6 weeks later (T1). We will invite participants randomised to the intervention arm to complete a qualitative exit interview.

Discussion: The results of this pilot trial will be used to determine whether a definitive trial is justified, and to inform the refinement of the UniVRse programme and trial procedures. In the longer term, the UniVRse intervention has the potential to be an effective and accessible psychological intervention for students with social anxiety.

Trial registration: Clinicaltrials.gov, NCT05704868. Registered 30th January 2023.

Background: Diabetes is a rapidly growing non-communicable disease globally, with 360 million out of 537 million affected adults residing in urban centres in 2021. In Pakistan, the situation is alarming, with diabetes prevalence alone exceeding 28.3% in urban areas, placing significant strain on the healthcare system exacerbated by limited resources and high management costs. Due to these multidimensional challenges, there is a growing emphasis on large-scale community-based participatory interventions like Participatory Learning and Action (PLA) for the prevention and control of type 2 diabetes mellitus (T2DM) and to improve the health outcomes of people living with T2DM. Building on a successful rural intervention from Bangladesh (D-Magic), our study aims to adapt PLA for T2DM prevention and control in urban settings and assess its feasibility in the urban context of Pakistan.

Methods: The EMPOWER-D feasibility trial is a two-arm cluster randomised control trial (cRCT) with embedded economic and process evaluation, to be conducted in the urban setting of Karachi, Pakistan. Six clusters, defined as blocks with a population of 1500, will be randomly allocated (1:1) to intervention and control arms. The intervention arm will participate in an 18-month PLA intervention, which includes monthly community meetings where group members will identify, prioritise, and address issues related to T2DM and its associated risk factors. Recruitment, appropriateness, and intervention fidelity will be assessed, alongside anthropometric, biochemical, and sociodemographic data collection. The trial data will be descriptively reported for the feasibility outcomes.

Discussion: This EMPOWER-D feasibility trial is among the first to implement a culturally tailored PLA intervention to prevent and control T2DM in urban low- and middle-income countries (LMICs). By conducting a feasibility cRCT trial, we aim to generate critical insights into this approach's feasibility in an urban setting, informing the implementation of a future definitive trial. Addressing T2DM aligns with the Sustainable Development Goals for 2030, exploring how community-based research can empower LMICs to tackle local health risks and targets.

Trial registration: The trial is registered at Clinicaltrials.gov on 26th August 2024 [NCT06570057].

Trial acronym: Engagement of coMmunity through Participatory learning and action for cOntrol and preVEntion of type 2 Diabetes and its Risk factors: Urban Feasibility Trial (EMPOWER-D-UFT).

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.