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

January 15, 2010
April 26, 2013
March 2010
January 2013   (final data collection date for primary outcome measure)
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin [ Time Frame: Two years ] [ Designated as safety issue: No ]
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01051245 on ClinicalTrials.gov Archive Site
Quality of care process measures [ Time Frame: Two years ] [ Designated as safety issue: No ]
Quality of care process measures [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effectiveness of a High-risk Diabetic Patients Program
Effectiveness of a High-risk Diabetic Patients Program

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Case manager counseling
  • 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).
    Intervention: Other: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
223
March 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01051245
1494
No
Gaston Perman, Hospital Italiano de Buenos Aires
Hospital Italiano de Buenos Aires
Not Provided
Principal Investigator: Gastón Perman, MD, MSc Hospital Italiano de Buenos Aires
Hospital Italiano de Buenos Aires
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP