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

NCT ID: NCT02586545

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-12-31

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Shared care

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Shared care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Metropolitan University College

OTHER

Sponsor Role: collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Lene Munch

MHS, Ph.D.-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lene Munch, MHS, Ph.D.-student

Role: PRINCIPAL_INVESTIGATOR

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark.

Locations

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 27259669 (View on PubMed)

Other Identifiers

DIA-1234

Identifier Type: -

Identifier Source: org_study_id