Effectiveness of a High-risk Diabetic Patients Program

Study Overview
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Brief Summary
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The purpose of this study is to determine whether case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care.

Official Title
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Effectiveness of a High-risk Diabetic Patients Program

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Case manager counseling
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diabetes mellitus Age between 18 and 80 years old Target organ damage (either macrovascular or microvascular) Patient's acceptance to participate Exclusion Criteria: Moderate to severe dementia Life expectancy lower than one year Justified negative from primary care physician to intervene the patient.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Case management<br>Patients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets. | Behavioral: Case manager counseling<br>* Patients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets.<br>|
| Placebo Comparator: Usual care group<br>Usual care provided by primary care physician and/or specialist. Free access to diabetes educational workshops. Regular delivery of educational brochures (not personally targeted). | Other: Usual care<br>* Usual care provided by primary care physician and/or specialist according to patients' needs and professional criteria. Includes free access to educational diabetes workshops and educational brochures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of care process measures |  | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2 [C18.452.394.750.149], Case Management [N04.590.233.624.250], Disease Management [N04.590.607], Diabetes Complications [C19.246.099]