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Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus (DCGP)

This study has been completed.
Sponsor:
Information provided by:
Research Unit Of General Practice, Copenhagen
ClinicalTrials.gov Identifier:
NCT01074762
First received: February 23, 2010
Last updated: NA
Last verified: July 2003
History: No changes posted
  Purpose

The aims of a concluding 14-year follow-up study are:

  • To investigate what long-term effect the project model for structured, personalized diabetes care has on 1) the patients' mortality and development of diabetic complications, 2) the patients' use of services from the primary and secondary sector, 3) the patients' self-rated health and motivation, and 4) the doctor-patient relationship.

Condition Intervention
Diabetes Mellitus
Quality of Health Care
Health Services Research
 Behavioral: Structured personal care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Diabetes Care in General Practice Study: Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Research Unit Of General Practice, Copenhagen:

Primary Outcome Measures:
  • Mortality [ Time Frame: From diabetes diagnosis until median14 year after study start ] [ Designated as safety issue: No ]
    The vital status of all patients was certified on the 31 January, 2006 through The Danish Civil Registration System (www.cpr.dk) which includes complete and continuously updated information on all Danish residents on vital status.

  • Diabetic retinopathy [ Time Frame: at 6 year and 14 year after study start ] [ Designated as safety issue: No ]
    Incidence of diabetic retinopathy

  • Urinary albumin concentration [ Time Frame: at 6 year and 14 year after study start ] [ Designated as safety issue: No ]
    Incidence of urinary albumin concentration > 15 mg/l

  • Myocardial infarction [ Time Frame: From diabetes diagnosis until median14 year after study start ] [ Designated as safety issue: No ]
    Incidence of myocardial infarction. The national hospital discharge registry provided information on hospital admissions for myocardial infarction, stroke, and amputation from diagnosis until December 31, 2005.

  • Stroke [ Time Frame: From diabetes diagnosis until median14 year after study start ] [ Designated as safety issue: No ]
    Incidence of stroke. The national hospital discharge registry provided information on hospital admissions for myocardial infarction, stroke, and amputation from diagnosis until December 31, 2005.


Secondary Outcome Measures:
  • New peripheral neuropathy [ Time Frame: at 6 year and 14 year after study start ] [ Designated as safety issue: No ]
  • New angina pectoris [ Time Frame: at 6 year and 14 year after study start ] [ Designated as safety issue: No ]
  • New intermittent claudication [ Time Frame: at 6 year and 14 year after study start ] [ Designated as safety issue: No ]
  • Amputation [ Time Frame: From diabetes diagnosis until median14 year after study start ] [ Designated as safety issue: No ]
    Incidence of amputation. The national hospital discharge registry provided information on hospital admissions for myocardial infarction, stroke, and amputation from diagnosis until December 31, 2005.


Enrollment: 1470
Study Start Date: March 1989
Study Completion Date: February 1996
Primary Completion Date: February 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Routine general practice care
In the comparison group, doctors were free to choose any treatment and change it over time. The study coordinating centre did not contact comparison practices after the end of recruitment (late 1991) until 1995.
 Behavioral: Structured personal care
General practitioners (GPs) were recommended to perform regular follow up every three months and an annual screening for diabetic complications. The GP was requested to define, together with the patient, the best possible goals for blood glucose concentration, glycated haemoglobin (HbA1c), diastolic blood pressure, and lipids within three predefined categories. At each quarterly consultation, the GP was asked to compare the achievements with the goal and consider changing either goal or treatment accordingly. The doctors received annual descriptive feedback reports on individual patients. The GPs were introduced to possible solutions to therapeutic problems through clinical guidelines supported by an annual half day seminar. Patient leaflets were produced for the doctor to hand out.

Detailed Description:

Type 2 diabetes (T2DM) is an increasingly common illness that is linked to considerable excessive mortality. There are many indications that treatment of raised blood pressure and blood glucose as well as dyslipidaemia can postpone the development of diabetic complications. Treatment of T2DM is primarily done in general practice, where the results are not satisfactory. The purpose of the project is to create a basis so the existing research-based knowledge can be used to improve the quality of diabetes care in general practice.

The answer will be based on the information from 1,428 newly diagnosed diabetic patients aged 40 or over who were followed since 1989 in a randomised trial among more than 600 general practitioners. The intervention, which ended at the beginning of 1996, provided optimum conditions for follow-up, doctor-patient communication and treatment, among other ways by training the doctors, producing clinical guidelines and setting individual treatment goals. In the project, the general practitioner is seen as the coordinator of the whole health system's prophylactic efforts in relation to the individual diabetic patient.

The aims of a concluding 14-year follow-up are:

  • To investigate what long-term effect the project model for structured, personalized diabetes care has on 1) the patients' mortality and development of diabetic complications, 2) the patients' use of services from the primary and secondary sector, 3) the patients' self-rated health and motivation, and 4) the doctor-patient relationship.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients aged 40 or older with newly diagnosed diabetes between 1 March 1989 and 28 February 1991 based on hyperglycaemic symptoms or raised blood glucose values measured in general practice

Exclusion Criteria:

  • threatening somatic disease, severe mental illness, or unwillingness to participate. For our analysis, we also excluded non-white patients and patients whose diagnosis was not established by a blood glucose measurement at a major laboratory within 500 days after diagnosis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074762

Locations
Denmark
The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5
Copenhagen, Denmark, DK-1014
Sponsors and Collaborators
Research Unit Of General Practice, Copenhagen
  More Information

No publications provided

Responsible Party: Niels de Fine Olivarius, Research Unit Of General Practice, Copenhagen
ClinicalTrials.gov Identifier: NCT01074762     History of Changes
Other Study ID Numbers: DCGP1989
Study First Received: February 23, 2010
Last Updated: February 23, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Research Unit Of General Practice, Copenhagen:
Diabetes mellitus
Quality of health care
Health services research

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013