Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Quality of Health Care; Health Services Research
• Interventions: Behavioral: Structured personal care

• Registration Number: NCT01074762
• Lead Sponsor: Research Unit Of General Practice, Copenhagen

Brief Summary

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.

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.

Study Timeline

• Study Start: 1989-03
• Primary Completion: 1996-02
• Study Completion: 1996-02
• Status Verified: 2003-07
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Last Update Submitted: 2010-02-23
• Study First Posted: 2010-02-24
• Last Update Posted: 2010-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1470

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine general practice care	Structured personal 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.

Primary Outcome Measures

Name	Time	Method
Diabetic retinopathy	at 6 year and 14 year after study start	Incidence of diabetic retinopathy
Urinary albumin concentration	at 6 year and 14 year after study start	Incidence of urinary albumin concentration \> 15 mg/l
Myocardial infarction	From diabetes diagnosis until median14 year after study start	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.
Mortality	From diabetes diagnosis until median14 year after study start	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.
Stroke	From diabetes diagnosis until median14 year after study start	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

Name	Time	Method
Amputation	From diabetes diagnosis until median14 year after study start	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.
New angina pectoris	at 6 year and 14 year after study start
New peripheral neuropathy	at 6 year and 14 year after study start
New intermittent claudication	at 6 year and 14 year after study start

Trial Locations

Locations (1)

The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5; 🇩🇰 Copenhagen, Denmark