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

Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Other: Home-based disease management

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01284400

UMIN000000565 (Other Identifier)

J-HOMECARE

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Disease management

Experimental group

Treatment:

Other: Home-based disease management

Usual treatment and care

No Intervention group