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OpenTrials
Completed

NCT Number: NCT01051245

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, (C1181ACH), Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Two years

Secondary outcomes

  1. Quality of care process measures

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2010
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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