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Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial.

Abstract：

BACKGROUND:Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions. METHODS/DESIGN:The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios. DISCUSSION:We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs. TRIAL REGISTRATION:Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014).

journal_name

Trials

journal_title

Trials

authors

Bozorgmehr K,Szecsenyi J,Ose D,Besier W,Mayer M,Krisam J,Jacke CO,Salize HJ,Brandner R,Schmitt S,Kiel M,Kamradt M,Freund T

doi

10.1186/1745-6215-15-243

subject

Has Abstract

pub_date

2014-06-21 00:00:00

pages

243

issn

1745-6215

pii

1745-6215-15-243

journal_volume

pub_type

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Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial.