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Completed

NCT Number: NCT01284400

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Home-based disease management

Other

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

Primary outcomes

  1. Psychosocial status (depression, anxiety)

    Time frame: up to 12 months

Secondary outcomes

  1. Death

    Time frame: up to 12 months

  2. Readmission due to heart failure

    Time frame: up to 12 months

  3. Hospital admission

    Time frame: up to 12 months

  4. Quality of life

    Time frame: up to 12 months

  5. Physical activity

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Japanese Heart Failure Outpatient Disease Management Evaluation Investigators

Network

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2011
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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