Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01074762
Study type	Interventional
Source	Research Unit Of General Practice, Copenhagen
Contact
Status	Completed
Phase	N/A
Start date	March 1989
Completion date	February 1996

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms