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

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Home-based disease management

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring heart failure, disease management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

1. Age ≥ 18 years

Exclusion criteria

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Disease management

Usual treatment and care

Arm Description

Outcomes

Primary Outcome Measures

Psychosocial status (depression, anxiety)

Secondary Outcome Measures

Death

Readmission due to heart failure

Hospital admission

Quality of life

Physical activity

Full Information

NCT ID

NCT01284400

First Posted

January 25, 2011

Last Updated

May 31, 2011

Sponsor

Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

1. Study Identification

Unique Protocol Identification Number

NCT01284400

Brief Title

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

Official Title

The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

heart failure, disease management

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Disease management

Arm Type

Experimental

Arm Title

Usual treatment and care

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Home-based disease management

Intervention Description

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

Primary Outcome Measure Information:

Title

Psychosocial status (depression, anxiety)

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Death

Time Frame

up to 12 months

Title

Readmission due to heart failure

Time Frame

up to 12 months

Title

Hospital admission

Time Frame

up to 12 months

Title

Quality of life

Time Frame

up to 12 months

Title

Physical activity

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria 1. Age ≥ 18 years Exclusion criteria 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroyuki Tsutsui, MD, PhD

Organizational Affiliation

Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

23502992

Citation

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.

Results Reference

derived

PubMed Identifier

21640556

Citation

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. Erratum In: J Cardiol. 2013 Mar;61(3):245.

Results Reference

derived

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

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