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Published in: BMC Hematology 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Marlous J. Madderom, Jessica Heijdra, Elisabeth M. W. J. Utens, Suzanne Polinder, Anita W. Rijneveld, Marjon H. Cnossen

Published in: BMC Hematology | Issue 1/2016

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Abstract

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.
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Metadata
Title
A randomized controlled trial studying the effectiveness of group medical appointments on self-efficacy and adherence in sickle cell disease (TEAM study): study protocol
Authors
Marlous J. Madderom
Jessica Heijdra
Elisabeth M. W. J. Utens
Suzanne Polinder
Anita W. Rijneveld
Marjon H. Cnossen
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Hematology / Issue 1/2016
Electronic ISSN: 2052-1839
DOI
https://doi.org/10.1186/s12878-016-0058-4

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