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

NCT01284400 | Completed Phase 3 DMC

• 2 other identifiers: J-HOMECAREUMIN000000565
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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

Keywords

heart failure; disease management

Outcome Measures

Primary Outcomes (1)

• Psychosocial status (depression, anxiety)

  up to 12 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Disease management

EXPERIMENTAL

Other: Home-based disease management

Usual treatment and care

NO INTERVENTION

Interventions

Home-based disease management OTHER

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

Disease management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years

You may not qualify if:

• End-stage HF defined as requiring mechanical support or continues intravenous inotropic support
• A serious life-threatening illness with a life-expectancy of \<6 months Within the past 3 months
• Cognitive dysfunction
• Substance abuse or psychotic disorder
• Managed by visiting nursing
• Long distance between patients' home and hospital

Sponsors & Collaborators

• Japanese Heart Failure Outpatient Disease Management Evaluation Investigators: lead

Related Publications (2)

• 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.

  PMID: 23502992 DERIVED

• 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.

  PMID: 21640556 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hiroyuki Tsutsui, MD, PhD

  Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 27, 2011
• Study Start: January 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 2, 2011

Record last verified: 2011-05