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

Primary Purpose

Hypertension, Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Case Management
Usual Care
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Diabetes Mellitus, Type 2, Case Management

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CESFAM La Faena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case Management

Control

Arm Description

Usual Care at Primary Health Care

Outcomes

Primary Outcome Measures

Glycated Hemoglobin
Systolic and Diastolic Blood Pressure

Secondary Outcome Measures

Quality of Care
Measured by Clinical records audits
Patient satisfaction
Measured by a questionnaire
Medication adherence
Measured by Morisky- Green questionnaire

Full Information

First Posted
May 3, 2016
Last Updated
September 26, 2017
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
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1. Study Identification

Unique Protocol Identification Number
NCT02762695
Brief Title
Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile
Official Title
Evaluation of a Model of Care for People With Hypertension and Type II Diabetes Based on Case Management and Risk Adjustment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2016 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Type 2
Keywords
Hypertension, Diabetes Mellitus, Type 2, Case Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
616 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case Management
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual Care at Primary Health Care
Intervention Type
Other
Intervention Name(s)
Case Management
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care at Primary Health Care Center
Primary Outcome Measure Information:
Title
Glycated Hemoglobin
Time Frame
One year
Title
Systolic and Diastolic Blood Pressure
Time Frame
One year
Secondary Outcome Measure Information:
Title
Quality of Care
Description
Measured by Clinical records audits
Time Frame
one year
Title
Patient satisfaction
Description
Measured by a questionnaire
Time Frame
one year
Title
Medication adherence
Description
Measured by Morisky- Green questionnaire
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando C Poblete, Master
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Study Chair
Facility Information:
Facility Name
CESFAM La Faena
City
Peñalolén
State/Province
RM
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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