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

NCT02586545 | Completed DMC

• 1 other identifier: DIA-1234
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months

  Baseline and follow-up at 12, 24 and 36 months

Secondary Outcomes (1)

• The proportion of patients who meet national standard indicators reflecting quality of care

  Follow-up at 12, 24 and 36 months after baseline

Other Outcomes (3)

• Change from baseline Quality of life at 12, 24 and 36 months

  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

  Baseline and follow-up at 12, 24 and 36 months

Study Arms (2)

Shared care model

EXPERIMENTAL

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

Mono sectorial care

NO INTERVENTION

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.

Interventions

Shared care OTHER

Shared care model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Metropolitan University College: collaborator

Study Sites (1)

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, DK-2900, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27259669 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lene Munch, MHS, Ph.D.-student

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MHS, Ph.D.-student

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 26, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

DK (1)