Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure

NCT07660237 | Completed

• 1 other identifier: 202300968B0
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effects of a structured transitional care program on depression, self-efficacy, and self-care behaviors in patients with heart failure. Outcomes will be assessed before discharge and at 1 and 3 months after discharge.

Conditions

Heart Failure and Reduced Ejection Fraction; Transitional Care

Keywords

Depression; Self-Efficacy; Self-Care

Outcome Measures

Primary Outcomes (3)

• Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)

  Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).

  Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

• Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES)

  Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES).

  Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

• Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI)

  Self-care behaviors will be assessed using the Self-Care of Heart Failure Index (SCHFI).

  Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

Study Arms (2)

Transitional Care Program Group

EXPERIMENTAL

Participants received a structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.

Behavioral: Structured Transitional Care Program

Usual Care Group

ACTIVE COMPARATOR

Participants received routine discharge education and standard follow-up care provided by the hospital after dischar

Other: Usual Care

Interventions

Structured Transitional Care Program BEHAVIORAL

A structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.

Transitional Care Program Group

Usual Care OTHER

Participants received standard discharge routine care provided by the hospital after discharge.

Usual Care Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of heart failure confirmed by a specialist physician. Patients with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤40%.
• Age ≥20 years. Clear consciousness and no cognitive impairment. Ability to communicate in Mandarin, Taiwanese, or Hakka. Ability to complete the questionnaire independently or with assistance from the researcher.

You may not qualify if:

• Patients who are unable to be discharged during the current hospitalization. Severe consciousness impairment, cognitive impairment, or severe mental illness affecting study participation.
• Patients who are illiterate or unable to express themselves verbally. Patients who are bedridden long-term or unable to perform self-care activities. Patients who refuse to participate in the study. Patients who are already enrolled in a case management program.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Guishan, Taoyuan City, 33305, Taiwan

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Depression

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the behavioral and nursing intervention, participants and investigators will not be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either the structured transitional care program group or the usual care group in a parallel design.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 22, 2026
• Study Start: July 19, 2023
• Primary Completion: January 18, 2024
• Study Completion: June 25, 2024
• Last Updated: June 22, 2026

Record last verified: 2026-05

Locations

TW (1)