A network-based care management intervention for patients with type II diabetes and multiple comorbidities (GEDIMAplus)

ISRCTN	ISRCTN83908315
DOI	https://doi.org/10.1186/ISRCTN83908315
Secondary identifying numbers	01KQ1003B

Submission date: 30/01/2014
Registration date: 25/02/2014
Last edited: 13/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The increasing occurrence of multiple, co-occurring long-term disease conditions places a burden for modern health systems. Methods to manage patient care (care management interventions) in Germany have been evaluated with promising results. However, further studies are necessary to explore the full potential of care management interventions for the improvement of outpatient diabetes care. The aim of this study is to find out how well a GP surgery net-based, IT-supported care management intervention with integrated telephone monitoring works for patients with type II diabetes and multiple co-occurring long-term conditions.

Who can participate?
Patients with type II diabetes and at least two severe long-term conditions, who are enrolled in the Disease-Management-Program Diabetes mellitus type 2 (DMP Diabetes) can participate in the study.

What does the study involve?
Patients will be randomly allocated to case management (PTC) or usual care (TAU). Both PTC and TAU receive usual care. Patients allocated to PTC receive an 18-month care management intervention given by a trained health care assistant as an add-on to usual care. This complex care management intervention consists of the two main elements: assessments including home visits and regular telephone-monitoring.

What are the possible benefits and risks of participating?
All participants and informal care givers help to improve the care given for patients with diabetes and multiple co-occurring conditions in the future. In addition patients in the PTC will potentially benefit by an improved diabetes-related self-care behaviour. There arent any risks expected for patients and informal care givers taking part in this study.

Where is the study run from?
The study is run by Genossenschaft Gesundheitsprojekt Mannheim e.G. (GGM), Germany from 30 primary care practices (PCP).

When is the study starting and how long is it expected to run for?
The study starts in February 2014 and is expected to run for 18 months.

Who is funding the study?
The Federal Ministry for Education and Research (BMBF), Germany.

Who is the main contact?
Dr Dominik Ose, MPH
dominik.ose@med.uni-heidelberg.de

Contact information

Prof Dr. med. Joachim Szecsenyi
Scientific

Voßstr. 2, Geb. 37
Heidelberg
69115
Germany

Study information

Study design	Prospective 18-month multi-center investigator-blinded two-armed open label individual-level randomized parallel-group superiority trial (RCT)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multi-center, individual-level randomized, 18-month, parallel-group superiority trial to compare the efficacy of a complex primary care practice network-based care management intervention versus usual care in the improvement of self-care behavior among patients with type II diabetes and multiple comorbidities (GEDIMAplus)
Study objectives	To assess the efficacy of a primary care practice net-based, IT-supported care management intervention with integrated telephone monitoring for patients with diabetes type II and multiple co-occurring chronic conditions.
Ethics approval(s)	The Medical University of Heidelberg Ethics Committee, Germany, 02/12/2013, Ref.: S-590/2013
Health condition(s) or problem(s) studied	Diabetes mellitus type 2 and mulitple co-occuring chronic conditions.
Intervention	Participants are randomized to two groups: 1. Intervention: The 18-month care management intervention (GEDIMAplus) is delivered by a trained health care assistant as add-on to usual care and consists of 2 main elements: 3 home visits including structured assessment of medical and social needs and 24 structured telephone monitoring contacts. All elements are IT-supported using a care manager-software as intervention platform. In addition goal setting between primary care physicians and patient based on the results of the assessment will take place. 2. Control: usual care in the scope of the statutory health care system (DMP Diabetes). Care for other diseases (chronic or acute) besides diabetes is managed by PCP physicians individually based on personal experience, guidelines and/or patients preferences. Data collection: baseline (T0), primary endpoint after 9 months (T1), follow-up after 18 months (T2)
Intervention type	Other
Primary outcome measure	Change in diabetes related selfcare behavior using a German version of the revised Summary of diabetes self-care activities measure (SDSCA-G) after 9 months.
Secondary outcome measures	1. Change in SDSCA-G at T2 2. Mean change in each of the five dimension of self-care captured by the SDSCA-G 3. Mean change in physician-reported glycosylated hemoglobin A1 (HbA1c %) at T1/T2 4. The cumulative incidence of physician-reported (severe) symptomatic hypoglycemia at T1/T2 5. Mean change in patient-reported health related quality of life (HRQL) at T1/T2 6. Mean change in patient-reported self-efficacy to cope with chronic conditions 7. Differences in service utilization 8. Costs of health care provision and financial burden of informal care between intervention and control group
Overall study start date	01/02/2014
Completion date	31/07/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	A total of 592 patients (291 per arm) will be recruited in 30 PCPs.
Total final enrolment	495
Key inclusion criteria	Primary care practices (PCPs): PCP physicians must fulfill the following criteria: Specialized in General Practice, Internal Medicine or Practical Physician (praktischer Arzt) and function as Primary care physician (Hausarzt) according to German regulations. Both single and group practices (Gemeinschaftspraxen) are eligible to participate. Patients: To be eligible for participation in the study, patients have to be: 1. Aged 18 years or above 2. Diagnosed with type 2 diabetes mellitus (ICD 10: E11-E14) 3. Enrolled in the DMP Diabetes, and diagnosed with at least two severe chronic comorbidities (schwerwiegende chronische Erkrankung) according to the definition enshrined in § 62 SGB V. Additionally, written informed consent is a prerequisite for participation in the study. Patients caregiving family member: A caregiving family member is defined as the family member who (from the patients perspective) spends the largest amount of time with informal care (e.g. spouse, partner, father, mother, son, daughter, others) and lives in the same household.
Key exclusion criteria	PCPs and patients caregiving family members: PCPs and patients caregiving family members who do not fulfill the inclusion criteria will be excluded. Patients: 1. Patients who do not fulfill the inclusion criteria will be excluded. Additional exclusion criteria are patients with: Severe acute psychiatric disorders, e.g. schizophrenia, schizotypal and delusional disorders (ICD 10: F20-F29), dementia (ICD 10: F00-F03), mental and behavioral disorders due to psychoactive substance use (ICD 10: F11-F16; F18; F19) (except for alcohol (ICD 10: F10) and tobacco use (ICD 10: F17)), malignant neoplasms (ICD 10: C00-C97) and/or current chemotherapy or radiotherapy, transplanted organ and tissue status (ICD 10: Z94), care involving dialysis (ICD 10: Z49), insurmountable language and communication problems, emergency cases.
Date of first enrolment	01/02/2014
Date of final enrolment	31/07/2015

Locations

Countries of recruitment

Germany

Study participating centre

Voßstr. 2, Geb. 37

Heidelberg
69115
Germany

Sponsor information

Federal Ministry for Education and Research (BMBF) (Germany)
Government

Hannoversche Straße 28-30
Berlin
10115
Germany

"ROR"	https://ror.org/04pz7b180

Funders

Funder type

Government

Federal Ministry for Education and Research (BMBF), Germany, in the scope of the project 'Gesundheitsregion der Zukunft'

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	21/06/2014		Yes	No
Results article	results	12/06/2019	13/06/2019	Yes	No

Editorial Notes

13/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.