Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile

Hypertension Clinical Trial

Official title:

Evaluation of a Model of Care for People With Hypertension and Type II Diabetes Based on Case Management and Risk Adjustment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02762695
• Other study ID #: 15-277
• Secondary ID: ID15I10277
• Status: Active, not recruiting
• Phase: N/A
• First received: May 3, 2016
• Last updated: September 26, 2017
• Start date: May 4, 2016
• Est. completion date: June 2018

Study information

• Verified date: September 2017
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Additionally, this intervention would provide a better quality of care and a more efficient health provision.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 616
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• Adults diagnosed with Hypertension and/ or Type 2 Diabetes

Exclusion Criteria:

• Severe mental illness and / or deterioration of cognitive abilities.

• Severe hearing loss.

• Diagnosed with cancer

• Stage 4 or 5 of chronic kidney disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Other:
• Case Management
A model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk. The core elements of this strategy are: a. processes to identify specific population and their risk; b. evidence-based practice guidelines according to risk (higher risk, more interventions and monitoring by a nurse, lower risk, higher emphasis on self-care); c. Practice models based on collaboration between health team members leaded by a nurse; d. self-management education for patients; e. monitoring patients face to face or by telephone to ensure to follow the care program (blood test, medical consultation, for example); e. measurement of process and outcomes.
• Usual Care
Usual Care at Primary Health Care Center

Locations

Country	Name	City	State
Chile	CESFAM La Faena	Peñalolén	RM

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Comisión Nacional de Investigación Científica y Tecnológica

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated Hemoglobin		One year
Primary	Systolic and Diastolic Blood Pressure		One year
Secondary	Quality of Care	Measured by Clinical records audits	one year
Secondary	Patient satisfaction	Measured by a questionnaire	one year
Secondary	Medication adherence	Measured by Morisky- Green questionnaire	one year