Recruitment for a digitally based follow-up program for people with chronic obstructive pulmonary disease: a pilot cluster randomized controlled trial

BACKGROUND: Recruiting participants for clinical trials in primary care settings remains challenging, not least for interventions targeting individuals with chronic obstructive pulmonary disease (COPD). Clinical outcomes and the effects of interventions receive considerable attention compared to factors influencing recruitment success. Identifying and addressing possible barriers and facilitators is essential for optimizing recruitment strategies and ensuring the feasibility of trials. AIM: This study aimed to assess uncertainties regarding recruitment for a digitally based Guided Self-Determination (GSD) follow-up program for people with COPD, prior to a fully powered cluster randomized controlled trial (cRCT), and to explore characteristics of primary care practices and patients willing to be included in the study. METHODS: The intervention was a 9-month digitally based follow-up program performed with the GSD counseling method, conducted by nurses in primary care practices. Eligible primary care practices were invited to participate, and participants were recruited through their respective practices. The primary feasibility outcome was recruitment, assessed at both the practice (cluster) and patient (participants) level. Eligible participants were people between 35 and 80 years diagnosed with COPD. Baseline characteristics included demographic data, COPD Assessment Test, Dyspnea-12, WHO-5 Well-being Index, and Health Education Impact Questionnaire domains. Progression criteria Go, Amend, and Stop were applied to assess feasibility. RESULTS: Recruitment occurred from May to December 2024. Of 16 eligible practices, 12 (75%) responded, of which ten (83%) agreed to participate, corresponding to 63% of the eligible practices. A total of 64 participants with COPD were recruited, 28 in the intervention and 36 in the control clusters. The overall median recruitment rate was 6.5 participants per cluster, 7 in the intervention clusters and 6 in the control clusters. One of three progression criteria, cluster recruitment, met the target Go, while cluster sizes and participant recruitment met the amended criteria. CONCLUSION: Recruitment was deemed feasible. However, successful cluster-level recruitment does not necessarily ensure effective patient enrollment, highlighting the necessity for amendments before a fully powered cRCT. Future research should integrate qualitative data obtained from patients and primary care practitioners to enhance the understanding of recruitment strategies. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06401512). Registered 23 April 2024, https://clinicaltrials.gov/study/NCT06401512.