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

NCT ID: NCT01284400

Last Updated: 2011-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-05-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Disease management

Group Type: EXPERIMENTAL

Home-based disease management

Intervention Type: OTHER

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

Usual treatment and care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home-based disease management

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

NETWORK

Sponsor Role: lead

Responsible Party

Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine

Principal Investigators

Hiroyuki Tsutsui, MD, PhD

Role: STUDY_CHAIR

Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine

References

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.

Reference Type: DERIVED

PMID: 23502992 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21640556 (View on PubMed)

Other Identifiers

UMIN000000565

Identifier Type: OTHER

Identifier Source: secondary_id

J-HOMECARE

Identifier Type: -

Identifier Source: org_study_id