Development of nurse-led disease management program to support outpatients with chronic heart failure

JRCT ID: jRCT1030220476

Registered date:29/11/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic Heart Failure
• Date of first enrollment: 29/11/2022
• Target sample size: 8
• Study type: Interventional

Intervention(s)

Perform pre-discharge education for heart failure according to the Clinical Guidelines for Acute and Chronic Heart Failure
Perform telephone-based education for patients and family member on the 3rd day after discharge
In case of discharge to the nursely home, we will provide the disease management plan to the staffs of the facility.
Performe face-to-face or telephone-based support once a week during the first month after discharge.
Performe face-to-face support (about 30 minutes) at the first outpatient visit after discharge.
Up to 3 months after discharge, face-to-face education will be performed once a month on outpatient visits. In addition, telephone-based education will be provided once a month.

Outcome(s)

Primary Outcome

Improvement or continuation of self-care behavior based on the Japanese version of the European Heart Failure Self-Care Behavior Scale (change in score of the European Heart Failure Self-Care Behavior Scale)
Prevention of exacerbation of symptoms (changes in serum BNP, NT-proBNP, etc.)

Secondary Outcome

Readmission due to heart failure within 30 days, 3 months, 6 months, and 1 year after discharge
Duration of home care until rehospitalization for HF (days)
Symptoms at unplanned visit (prevention of aggravation by early visit)

Key inclusion & exclusion criteria

• Age minimum: > 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

One or more hospital hospitalization for heart failure within one year (excluding hospitalization during the study period)
One or more criteria that associate decreased adherence such as living alone, decreased familial corporation, mental disorders (especially depression)
Patients who are scheduled to discharge to an outpatient clinic

• Exclude criteria: Difficult to obtain informed consent due to impairment of cognitive function.

Related Information

• Primary Sponsor: Masaru Obokata