Shared Care for Patients With Type 2 Diabetes Across the Primary and Secondary Health Care Sector

The aim of the study is to test the effect of a new shared care model for type 2 diabetes care and compare it with a standardized care management program in a specialized hospital-based out-patient clinic.

The hypothesis is that participants with type 2 diabetes followed in a shared care program will have a comparable outcome in HbA1c to participants receiving standard care.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Shared care

Detailed Description

The prevalence of patients with type 2 diabetes is in growth globally. In order to secure high quality in diabetes care it is necessary to rethink the way in which the care is organized. The investigators want to test a new model of shared care across the interface of primary and secondary care sector for patients with type 2 diabetes who are at risk stratification level 2. Based on a national and regional risk stratification model patients can be stratified to three levels according to risk and complexity of treatment: level 1 (uncomplicated), level 2 (intermediate risk) and level 3 (high risk).

The objective of the study is to show equal outcomes among the participants being treated in either a shared care program or an established program in a specialized outpatient clinic.

The study is a non-inferiority randomized controlled trial. The shared care model will be tested during a period of three years. All participants are offered four medical visits a year. The shared care intervention consists of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at a general practice. The control group is followed with four quarterly visits at the outpatient clinic including an annual comprehensive check-up. The recruitment period spans over approximately 12 months, and participants are randomized to intervention or control group in a 1:1 ratio.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, DK-2900
    • Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be over the age of 18 years
• The diagnosis of type 2 diabetes
• Risk stratification level 2
• Capable of speaking and writing in Danish
• Give oral and written consent before entering the study

Exclusion Criteria:

• Diagnosed with other types of diabetes than type 2 diabetes
• Risk stratification level 1 or 3
• Being pregnant or breastfeeding
• Having severe co-morbidity with life expectancy less than five years
• Being under such conditions, that the patient will not be able to show up or go through with the appointments (e.g. moderate to severe dementia and severe psychiatric conditions)
• Participating in long-lasting interventions (>2 weeks) that potentially affects the primary outcome in our study or patients participating in studies which include blood sampling amounting to >5 % of the blood volume two months prior to the randomisation and/or the follow-up visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared care model; Four visits a year: one annual comprehensive check-up at the outpatient diabetes clinic and three quarterly visits at the general practitioner.	Other: Shared care
No Intervention: Mono sectorial care; Treament as usual including four visits a year with the diabetes team at the outpatient clinic: an annual comprehensive check-up, identical to the one received by the intervention group, and three quarterly visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months	Baseline and follow-up at 12, 24 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients who meet national standard indicators reflecting quality of care	These indicators cover seven areas: HbA1c, blood pressure, low density lipoprotein, albuminuria, fundoscopy, foot examination and smoking status.	Follow-up at 12, 24 and 36 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Quality of life at 12, 24 and 36 months	Measured by the Short Form 36 (SF-36)	Baseline and follow-up at 12, 24 and 36 months
Change from baseline blood pressure at 12, 24 and 36 months		Baseline and follow-up at 12, 24 and 36 months
Change from baseline diabetes symptoms at 12, 24 and 36 months	Meassured by the Diabetes Symptom Checklist-revised (DSC-r).	Baseline and follow-up at 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Metropolitan University College
• Investigators: Principal Investigator: Lene Munch, MHS, Ph.D.-student, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark.

Publications and helpful links

General Publications

• Munch L, Bennich B, Arreskov AB, Overgaard D, Konradsen H, Knop FK, Vilsboll T, Roder ME. Shared care management of patients with type 2 diabetes across the primary and secondary healthcare sectors: study protocol for a randomised controlled trial. Trials. 2016 Jun 4;17(1):277. doi: 10.1186/s13063-016-1409-y.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DIA-1234