Effectiveness of a High-risk Diabetic Patients Program

NCT01051245 | Completed

• 1 other identifier: 1494
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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]

Outcome Measures

Primary Outcomes (1)

• Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin

  Two years

Secondary Outcomes (1)

• Quality of care process measures

  Two years

Study Arms (2)

Case management

ACTIVE COMPARATOR

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

Usual care group

PLACEBO COMPARATOR

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

Interventions

Case manager counseling 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.

Case management

Usual care 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.

Usual care group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetes mellitus
• Age between 18 and 80 years old
• Target organ damage (either macrovascular or microvascular)
• Patient's acceptance to participate

You may not qualify if:

• Moderate to severe dementia
• Life expectancy lower than one year
• Justified negative from primary care physician to intervene the patient.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, (C1181ACH), Argentina

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gastón Perman, MD, MSc

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Programs

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

AR (1)