Effectiveness of a High-risk Diabetic Patients Program

Hospital Italiano de Buenos Aires

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Case manager counseling; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01051245

1494

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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223 participants in 2 patient groups, including a placebo group

Case management

Active Comparator group

Description:

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.

Treatment:

Behavioral: Case manager counseling

Usual care group

Placebo Comparator group

Description:

Usual care provided by primary care physician and/or specialist. Free access to diabetes educational workshops. Regular delivery of educational brochures (not personally targeted).

Treatment:

Other: Usual care