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.

Additional Metadata
Keywords Adherence, Cost-effectiveness, Group medical appointment, Randomized controlled trial, Self-efficacy, Sickle cell disease
Persistent URL dx.doi.org/10.1186/s12878-016-0058-4, hdl.handle.net/1765/101353
Journal BMC Hematology
Citation
Madderom, M.J, Heijdra, J. (Jessica), Utens, E.M.W.J, Polinder, S, Rijneveld, A.W, & Cnossen, M.H. (2016). A randomized controlled trial studying the effectiveness of group medical appointments on self-efficacy and adherence in sickle cell disease (TEAM study): study protocol. BMC Hematology, 16(1). doi:10.1186/s12878-016-0058-4