Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus (DCGP)
Primary Purpose
Diabetes Mellitus, Quality of Health Care, Health Services Research
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Structured personal care
Sponsored by

About this trial
This is an interventional health services research trial for Diabetes Mellitus focused on measuring Diabetes mellitus, Quality of health care, Health services research
Eligibility 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.
Sites / Locations
- The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Routine general practice care
Arm Description
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.
Outcomes
Primary Outcome Measures
Mortality
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
Incidence of diabetic retinopathy
Urinary albumin concentration
Incidence of urinary albumin concentration > 15 mg/l
Myocardial infarction
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
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
New angina pectoris
New intermittent claudication
Amputation
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.
Full Information
NCT ID
NCT01074762
First Posted
February 23, 2010
Last Updated
February 23, 2010
Sponsor
Research Unit Of General Practice, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01074762
Brief Title
Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus
Acronym
DCGP
Official Title
The Diabetes Care in General Practice Study: Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2003
Overall Recruitment Status
Completed
Study Start Date
March 1989 (undefined)
Primary Completion Date
February 1996 (Actual)
Study Completion Date
February 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Research Unit Of General Practice, Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Quality of Health Care, Health Services Research
Keywords
Diabetes mellitus, Quality of health care, Health services research
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine general practice care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Structured personal care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality
Description
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.
Time Frame
From diabetes diagnosis until median14 year after study start
Title
Diabetic retinopathy
Description
Incidence of diabetic retinopathy
Time Frame
at 6 year and 14 year after study start
Title
Urinary albumin concentration
Description
Incidence of urinary albumin concentration > 15 mg/l
Time Frame
at 6 year and 14 year after study start
Title
Myocardial infarction
Description
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.
Time Frame
From diabetes diagnosis until median14 year after study start
Title
Stroke
Description
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.
Time Frame
From diabetes diagnosis until median14 year after study start
Secondary Outcome Measure Information:
Title
New peripheral neuropathy
Time Frame
at 6 year and 14 year after study start
Title
New angina pectoris
Time Frame
at 6 year and 14 year after study start
Title
New intermittent claudication
Time Frame
at 6 year and 14 year after study start
Title
Amputation
Description
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.
Time Frame
From diabetes diagnosis until median14 year after study start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
The Research Unit for General Practice in Copenhagen, Centre for Health and Community, Øster Farimagsgade 5
City
Copenhagen
ZIP/Postal Code
DK-1014
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31185995
Citation
Arreskov AB, Olsen MA, Pouplier SS, Siersma V, Andersen CL, Friis S, de Fine Olivarius N. The impact of cancer on diabetes outcomes. BMC Endocr Disord. 2019 Jun 11;19(1):60. doi: 10.1186/s12902-019-0377-0.
Results Reference
derived
PubMed Identifier
29216868
Citation
Heltberg A, Siersma V, Andersen JS, Ellervik C, Bronnum-Hansen H, Kragstrup J, de Fine Olivarius N. Socio-demographic determinants and effect of structured personal diabetes care: a 19-year follow-up of the randomized controlled study diabetes Care in General Practice (DCGP). BMC Endocr Disord. 2017 Dec 8;17(1):75. doi: 10.1186/s12902-017-0227-x.
Results Reference
derived
PubMed Identifier
26607637
Citation
Krag MO, Hasselbalch L, Siersma V, Nielsen AB, Reventlow S, Malterud K, de Fine Olivarius N. The impact of gender on the long-term morbidity and mortality of patients with type 2 diabetes receiving structured personal care: a 13 year follow-up study. Diabetologia. 2016 Feb;59(2):275-85. doi: 10.1007/s00125-015-3804-4. Epub 2015 Nov 26.
Results Reference
derived
PubMed Identifier
26602087
Citation
Larsen JR, Siersma VD, Davidsen AS, Waldorff FB, Reventlow S, de Fine Olivarius N. The excess mortality of patients with diabetes and concurrent psychiatric illness is markedly reduced by structured personal diabetes care: A 19-year follow up of the randomized controlled study Diabetes Care in General Practice (DCGP). Gen Hosp Psychiatry. 2016 Jan-Feb;38:42-52. doi: 10.1016/j.genhosppsych.2015.10.001. Epub 2015 Oct 19.
Results Reference
derived
PubMed Identifier
24599111
Citation
Lundstrom H, Siersma V, Nielsen AB, Brodersen J, Reventlow S, Andersen PK, de Fine Olivarius N. The effectiveness of structured personal care of type 2 diabetes on recurrent outcomes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP). Diabetologia. 2014 Jun;57(6):1119-23. doi: 10.1007/s00125-014-3204-1. Epub 2014 Mar 6.
Results Reference
derived
PubMed Identifier
23549519
Citation
Hansen LJ, Siersma V, Beck-Nielsen H, de Fine Olivarius N. Structured personal care of type 2 diabetes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP). Diabetologia. 2013 Jun;56(6):1243-53. doi: 10.1007/s00125-013-2893-1. Epub 2013 Apr 3.
Results Reference
derived
Learn more about this trial
Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus
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