Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: Home-based disease management
- Registration Number
- NCT01284400
- Lead Sponsor
- Japanese Heart Failure Outpatient Disease Management Evaluation Investigators
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Disease management Home-based disease management -
- Primary Outcome Measures
Name Time Method Psychosocial status (depression, anxiety) up to 12 months
- Secondary Outcome Measures
Name Time Method Death up to 12 months Readmission due to heart failure up to 12 months Hospital admission up to 12 months Quality of life up to 12 months Physical activity up to 12 months