Effectiveness of a High-risk Diabetic Patients Program

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01051245

Enrollment

223

Registered

2010-01-18

Start date

2010-03-31

Completion date

2013-03-31

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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]

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.

Interventions

BEHAVIORALCase 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.

OTHERUsual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin	Two years

Secondary

Measure	Time frame
Quality of care process measures	Two years

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026