Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus (DCGP)
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| ClinicalTrials.gov Identifier: NCT01074762 |
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Recruitment Status :
Completed
First Posted : February 24, 2010
Last Update Posted : February 24, 2010
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus Quality of Health Care Health Services Research | Behavioral: Structured personal care | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1470 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | March 1989 |
| Actual Primary Completion Date : | February 1996 |
| Actual Study Completion Date : | February 1996 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- Mortality [ Time Frame: 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.
- Diabetic retinopathy [ Time Frame: at 6 year and 14 year after study start ]Incidence of diabetic retinopathy
- Urinary albumin concentration [ Time Frame: at 6 year and 14 year after study start ]Incidence of urinary albumin concentration > 15 mg/l
- Myocardial infarction [ Time Frame: 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.
- Stroke [ Time Frame: 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.
- New peripheral neuropathy [ Time Frame: at 6 year and 14 year after study start ]
- New angina pectoris [ Time Frame: at 6 year and 14 year after study start ]
- New intermittent claudication [ Time Frame: at 6 year and 14 year after study start ]
- Amputation [ Time Frame: 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.
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074762
| Denmark | |
| The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5 | |
| Copenhagen, Denmark, DK-1014 | |
| Responsible Party: | Niels de Fine Olivarius, Research Unit Of General Practice, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT01074762 |
| Other Study ID Numbers: |
DCGP1989 |
| First Posted: | February 24, 2010 Key Record Dates |
| Last Update Posted: | February 24, 2010 |
| Last Verified: | July 2003 |
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Diabetes mellitus Quality of health care Health services research |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |