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

This study has been completed.
Sponsor:
Information provided by:
Japanese Heart Failure Outpatient Disease Management Evaluation Investigators
ClinicalTrials.gov Identifier:
NCT01284400
First received: January 25, 2011
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Other: Home-based disease management
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)

Resource links provided by NLM:


Further study details as provided by Japanese Heart Failure Outpatient Disease Management Evaluation Investigators:

Primary Outcome Measures:
  • Psychosocial status (depression, anxiety) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Readmission due to heart failure [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Hospital admission [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: January 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01284400

Sponsors and Collaborators
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
  More Information

No publications provided by Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroyuki Tsutsui, Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01284400     History of Changes
Other Study ID Numbers: J-HOMECARE, UMIN000000565
Study First Received: January 25, 2011
Last Updated: May 31, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japanese Heart Failure Outpatient Disease Management Evaluation Investigators:
heart failure
disease management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014