Effectiveness of a High-risk Diabetic Patients Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gaston Perman, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01051245
First received: January 15, 2010
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Case manager counseling
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a High-risk Diabetic Patients Program

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of care process measures [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: March 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: 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.
Placebo Comparator: 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).
Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051245

Locations
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, (C1181ACH)
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Gastón Perman, MD, MSc Hospital Italiano de Buenos Aires
  More Information

No publications provided

Responsible Party: Gaston Perman, Head of Medical Programs, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01051245     History of Changes
Other Study ID Numbers: 1494
Study First Received: January 15, 2010
Last Updated: April 26, 2013
Health Authority: Argentina: Ministry of Health

Keywords provided by Hospital Italiano de Buenos Aires:
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]

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014