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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284400

Enrollment

156

Registered

2011-01-27

Start date

2007-01-31

Completion date

2011-05-31

Last updated

2011-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, disease management

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.

Interventions

OTHERHome-based disease management

Symptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Psychosocial status (depression, anxiety)	up to 12 months

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026