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

Study Protocol

Elisabeth M. W. J. Utens¹  Anita W. Rijneveld²  Jessica Heijdra³  Marlous J. Madderom³  Marjon H. Cnossen³  Suzanne Polinder⁴ 

[1] Department of Child and Adolescent Psychiatry/Psychology, Erasmus University Medical Center – Sophia Children’s Hospital, PO Box 2060, Wytemaweg 80, 3000 CB, Rotterdam, The Netherlands;Department of Hematology, Erasmus University Medical Center, PO Box 2040, ‘s-Gravendijkwal 230, 3000 CA, Rotterdam, The Netherlands;Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children’s Hospital, PO Box 2060, Wytemaweg 80, 3000 CB, Rotterdam, The Netherlands;Department of Public Health, Erasmus University Medical Center, PO 2040, ‘s-Gravendijkwal 2030, 3000 CA, Rotterdam, The Netherlands;

关键词: Randomized controlled trial;    Sickle cell disease;    Self-efficacy;    Adherence;    Group medical appointment;    Cost-effectiveness;   

DOI  :  10.1186/s12878-016-0058-4

 received in 2015-01-28, accepted in 2016-06-16,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundSickle 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/designThe 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.DiscussionThis 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 registrationNTR4750 (NL42182.000.12). Registered 13 August 2014.

【 授权许可】

CC BY   
© Madderom et al. 2016