Roadblocks encountered in recruiting patients for a study of sleep disruption in Alzheimer's disease

Recruitment strategies and the roadblocks encountered in a clinical trial are described. A four-group, repeated measures design was used to test the effects of three sleep-related behavioral interventions on sleep disruption and related variables in Alzheimer's disease patients and their primary caregivers. Despite extensive recruitment efforts, enrollment did not meet expectations. Data analysis revealed three types of roadblocks to recruitment: caregiver resistance, provider resistance, and a mismatch of the disease characteristics with protocol requirements. Recommendations are made to help others solve recruitment problems.