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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014