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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
History of Changes

January 25, 2011
May 31, 2011
January 2007
May 2011   (final data collection date for primary outcome measure)
Psychosocial status (depression, anxiety) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01284400 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Heart Failure
Other: Home-based disease management
Symptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses
  • Experimental: Disease management
    Intervention: Other: Home-based disease management
  • No Intervention: Usual treatment and care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01284400
J-HOMECARE, UMIN000000565
Yes
Hiroyuki Tsutsui, Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
Japanese Heart Failure Outpatient Disease Management Evaluation Investigators
Not Provided
Study Chair: Hiroyuki Tsutsui, MD, PhD Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
Japanese Heart Failure Outpatient Disease Management Evaluation Investigators
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP