Clinical trial NCT01284400: Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure
Official title: The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: heart failure
disease management
Lead sponsor: Japanese Heart Failure Outpatient Disease Management Evaluation Investigators
Sponsor class: NETWORK
First posted: 2011-01-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Psychosocial status (depression, anxiety)
timeFrame: up to 12 months
Secondary outcomes:
measure: Death
timeFrame: up to 12 months
measure: Readmission due to heart failure
timeFrame: up to 12 months
measure: Hospital admission
timeFrame: up to 12 months
measure: Quality of life
timeFrame: up to 12 months
measure: Physical activity
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
name: Hiroyuki Tsutsui, MD, PhD
role: STUDY_CHAIR
References:
citation: Tsuchihashi-Makaya M, Matsuo H, Kakinoki S, Takechi S, Kinugawa S, Tsutsui H; J-HOMECARE Investigators. Home-based disease management program to improve psychological status in patients with heart failure in Japan. Circ J. 2013;77(4):926-33. doi: 10.1253/circj.cj-13-0115. Epub 2013 Mar 15.
citation: Tsuchihashi-Makaya M, Matsuo H, Kakinoki S, Takechi S, Tsutsui H; J-HOMECARE Investigators. Rationale and design of the Japanese heart failure outpatients disease management and cardiac evaluation (J-HOMECARE). J Cardiol. 2011 Sep;58(2):165-72. doi: 10.1016/j.jjcc.2011.04.004.