Barriers to recruitment of children with cerebral palsy in a trial of home-based training

Abstract

Many trials fail to include the targeted number of participants, causing scientific and ethical problems. The COAD trial of home-based training programs (HBTPs) for children with unilateral cerebral palsy (CP) encountered recruitment problems, even though the parent-delivered home-based approach complies with recent health-care developments in the Netherlands. The current project aimed to identify the barriers to recruitment in the COAD trial. This summative, multidimensional evaluation comprised informal conversational interviews in which stakeholders who had been involved reflected on the factors that impeded successful recruitment of participants into the COAD trial. Barriers to implementation and recruitment were clustered according to the constructs of the Consolidated Framework for Implementation Research (CFIR). Member checking validated the findings. A total of 41 stakeholders contributed to the evaluation. Barriers to the implementation of the HBTPs were identified within every domain of the CFIR (intervention characteristics, outer setting, inner setting, characteristics of individuals, and process). Parent-delivered home-based training was perceived as highly complex and in conflict with the pressures on and the needs of parents. Many parents preferred the alternative center-based group interventions. The involvement of a resonance group was highly valued, and opportunities for further enhancements emerged. Additionally, the importance of research consortia was emphasized. The appropriateness of the RCT as the study design was criticized. The findings of this study are summarized in a tool which provides a dozen directions for the successful recruitment of participants in pediatric rehabilitation research.

Designing a tool to support patient and public involvement in research projects: the Involvement Matrix

“…First experiences with the Involvement Matrix are proving promising. The Matrix has already generated a lot of national and international interest by researchers and patient organizations [39].…”

Aquatic high intensity interval training to improve aerobic capacity is feasible in adolescents with cerebral palsy: pilot randomised controlled trial

“…Adolescents in our study who met criteria but declined to participate cited similar barriers to enrollment reported in previous studies involving young people with disability such as time, travel and other trial involvement. 15,16 Our low recruitment fraction indicates a larger screening population would be required for recruitment of sample sizes for a definitive efficacy trial in this area. This requires multi-site collaboration and possible broadening of our target population to include GMFCS level I, posing challenges (including financial) associated with ensuring intervention fidelity.…”

“…Other studies in disability have reported poor tolerance to control group allocation. 15,16 Enjoyment and interest in the novel assessments for this sample possibly contributed to retention in our control group. Technical prowess in the intervention was neither measured nor a focus of participation which may have been a pleasurable and novel experience for children with cerebral palsy in a therapeutic environment.…”

Combined intensive therapies at home in spastic unilateral cerebral palsy with high bimanual functional performance. What do they offer? A comparative randomised clinical trial

“… 30 These programmes allow families to stay at home and not to travel to the therapy centre several times a week, arranging childcare for siblings, and requiring the child to be absent from school. 65 , 66 As a barrier, these home-based programmes may be stress inductors for parents. 67 Parents may experience pressure to comply, especially when the program is demanding, alteration of parent–child interaction during training with the role of parent changing to that of a therapy provider.…”