Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

Blatch-Jones, Amanda; Pek, Wei; Kirkpatrick, Emma; Ashton-Key, Martin

doi:10.1136/bmjopen-2018-022233

Cited by 90 publications

(85 citation statements)

References 19 publications

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“…These experiences can be further shared with peers working in similar settings or scenarios. Feasibility trials are paramount to test recruitment strategies, acceptability of study design and viability of eligibility criteria, thus consequently informing the progression of large-scale definitive clinical trials [11].…”

Section: Introductionmentioning

confidence: 99%

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Adegboye

Cocate

Benaim³

et al. 2020

Trials

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Background: There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy and also to describe the patient-, study protocol-and setting-related factors related to women's ineligibility and refusal to participate in the study. Methods: A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2 × 2 factorial feasibility clinical trial were used. Eighteen women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions, and the data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies. Results: Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (> 20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Nonparticipation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, patients being unresponsive to phone calls and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthful and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation costs) could hinder participation in the study. Conclusion: Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related sociodemographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings. Trial registration: ClinicalTrials.gov, NCT03148483. Registered on 11 May 2017.

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Section: Introductionmentioning

confidence: 99%

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Adegboye

Cocate

Benaim³

et al. 2020

Trials

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“…This study has numerous limitations including the small number of participants and lack of a control group. However, this is common of feasibility studies whose primary purpose is to determine whether future definitive trials of an intervention should take place and if so, what this trial should like (Blatch-Jones, Pek, Kirkpatrick, & Ashton-Key, 2018). Strengths of the study included the workshop delivery with real world partners in the context in which potential scale-up would occur.…”

Section: Discussionmentioning

confidence: 99%

A real world feasibility trial of the PLAYshop: an intervention to facilitate parent engagement in developing their child’s physical literacy

Lane

Reno

Predy

et al. 2020

Preprint

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Background Development of physical literacy, defined as “the motivation, confidence, physical competence, knowledge and understanding to value and take responsibility for engagement in physical activities for life”, can support children’s physically active behaviors and consequent health benefits. Little research exploring interventions to improve children's physical literacy exist, although substantive evidence shows parents play a key role in children's physically active behaviors and development of fundamental movement skills. The purpose of this study is to explore a novel, physical literacy intervention designed to assist parents to engage with their child in purposeful play; play that facilitates the development of physical literacy. Methods The PLAYshop was a 75-minute workshop to build parents' self-efficacy to support their child’s physical literacy through interactive activities and educational messages as well as educational resources focused on core physical literacy concepts. We collected quantitative pre- and post-workshop surveys of parents’ satisfaction, knowledge, confidence and intention to adopt practices as well as qualitative follow-up implementation focused interviews from both parents and facilitators. We used paired t-tests to examine changes in parents' self-reported physical literacy knowledge and confidence and thematic analysis of interviews to explore workshop feasibility. Results Six workshops were delivered to 33 parents of young children (3–8 years of age). 23 parents completed both pre- and post-workshop surveys. Follow-up interviews were completed with 11 parents and four workshop facilitators. Parents’ self-reported knowledge and confidence to support their child’s physical literacy development significantly increased after PLAYshop participation. Further, the majority of parents were satisfied with the workshop and motivated to apply workshop learnings at-home with their child. Workshop facilitators identified seven workshop strengths (e.g., workshop champions and skilled facilitators) and four challenges (e.g., recruitment and unfavorable spaces). Conclusions The PLAYshop was perceived positively by parents and facilitators and appeared to improve parent self-efficacy and intention to promote physical literacy with their child. Recruitment and attendance were key implementation challenges. The findings from this real world trial address an important evidence gap, highlighting areas for adaptations to improve the intervention and recruitment and suggesting that the PLAYshop is ready for efficacy testing in a more rigorous randomized controlled trial.

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“…The pilot randomised controlled trial [42] is conducted to ensure that the intervention can be delivered as intended and that safe assumptions can be made about effect size, rate of recruitment and retention in the future definitive clinical trial [43]. In this pilot study, the feasibility of implementing the EMPOWER-SUSTAIN Self-Management e-Health Intervention for patients with MetS in a primary care clinic will be evaluated.…”

Section: Study Settingmentioning

confidence: 99%

The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

Daud

Ramli

Abdul-Razak

et al. 2020

Trials

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Background: Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour of patients with MetS components (i.e., diabetes or hypertension). However, evidence is lacking in terms of their effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving activation and self-management behaviours among patients with MetS. This paper presents the study protocol.Methods: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18-60 years with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months, and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurses and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app, strengthening the patient-physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the changes in waist circumference, body mass index, blood pressure, patient physical activity level, eating behaviour, perception of chronic illness care, satisfaction with patient-physician interaction, and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. This includes acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and the intervention's potential effectiveness. Conclusion: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.

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Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

Cited by 90 publications

References 19 publications

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

A real world feasibility trial of the PLAYshop: an intervention to facilitate parent engagement in developing their child’s physical literacy

The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

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