MedDataX Logo

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

NCT ID: NCT02762695

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

616 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case Management

Group Type EXPERIMENTAL

Case Management

Intervention Type OTHER

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.

Control

Usual Care at Primary Health Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual Care at Primary Health Care Center

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Usual Care

Usual Care at Primary Health Care Center

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fernando Poblete Arrué

MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fernando C Poblete, Master

Role: STUDY_CHAIR

Pontificia Universidad Catolica de Chile

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CESFAM La Faena

Peñalolén, RM, Chile

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Chile

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ID15I10277

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15-277

Identifier Type: -

Identifier Source: org_study_id