Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure

May 31, 2011 updated by: Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)

Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management in patients with HF. Disease management could lead to the reduction of psychological distress, thus improving the self-care ability and adherence of patients with HF. In addition, very little information is available on the effectiveness of disease management programs in areas other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the efficacy of home-based disease management programs compared with usual care in improving psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

156

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

1. Age ≥ 18 years

Exclusion criteria

  1. End-stage HF defined as requiring mechanical support or continues intravenous inotropic support
  2. A serious life-threatening illness with a life-expectancy of <6 months Within the past 3 months
  3. Cognitive dysfunction
  4. Substance abuse or psychotic disorder
  5. Managed by visiting nursing
  6. Long distance between patients' home and hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disease management
Other: Home-based disease management
Symptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses
No Intervention: Usual treatment and care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychosocial status (depression, anxiety)
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: up to 12 months
up to 12 months
Readmission due to heart failure
Time Frame: up to 12 months
up to 12 months
Hospital admission
Time Frame: up to 12 months
up to 12 months
Quality of life
Time Frame: up to 12 months
up to 12 months
Physical activity
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

Investigators

  • Study Chair: Hiroyuki Tsutsui, MD, PhD, Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

June 2, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J-HOMECARE
  • UMIN000000565 (Other Identifier: University hospital Medical Information Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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