Effectiveness of a High-risk Diabetic Patients Program

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Case manager counseling; Other: Usual care

• Registration Number: NCT01051245
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-03
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case management	Case manager counseling	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.
Usual care group	Usual care	Usual care provided by primary care physician and/or specialist. Free access to diabetes educational workshops. Regular delivery of educational brochures (not personally targeted).

Primary Outcome Measures

Name	Time	Method
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin	Two years

Secondary Outcome Measures

Name	Time	Method
Quality of care process measures	Two years

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina