A randomized controlled trial studying the effectiveness of group medical appointments on self-efficacy and adherence in sickle cell disease (TEAM study): study protocol

BACKGROUND: Sickle cell disease (SCD) is endemic in non-Western countries. Due to migration, the prevalence of SCD in the Netherlands has increased. Adherence to medical treatment is recognized as a major problem area. Therefore, new effective interventions to increase adherence are urgently needed. METHODS/DESIGN: The TEAM study is an ongoing randomized controlled trial (RCT) to compare protocolized individual medical appointments (IMA’s; care-as-usual) with protocolized group medical appointments (GMA’s; novel intervention) in pediatric (n = 40) and adult (n = 60) patients. The study aims to assess the effectiveness of GMA’s (over a three year period) on patients’ self-efficacy, adherence, quality of life, morbidity, hospital admissions and satisfaction with the treating professional; as well as to test the cost-effectiveness of GMA’s. In both the IMA and GMA groups structured assessments will be performed at baseline (start of the study), after 1.5 and after 3 years. DISCUSSION: This is the first RCT to investigate the effectiveness of GMA’s on self-efficacy and adherence in pediatric and adult patients with SCD, including a cost-effectiveness analysis. TRIAL REGISTRATION: NTR4750 (NL42182.000.12). Registered 13 August 2014.