Effectiveness of a High-risk Diabetic Patients Program

NCT ID: NCT01051245

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-03-31

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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Case management

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.

Group Type ACTIVE_COMPARATOR

Case manager counseling

Intervention Type BEHAVIORAL

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

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Gaston Perman

Head of Medical Programs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gastón Perman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

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Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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1494

Identifier Type: -

Identifier Source: org_study_id

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