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Completed

NCT Number: NCT07660237

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Guishan, Taoyuan City, 33305, Taiwan

About this study

Heart failure is a chronic condition associated with frequent hospitalizations, poor self-care behaviors, psychological distress, and reduced quality of life. Patients with heart failure often experience depression and inadequate self-management after hospital discharge, which may negatively affect treatment adherence and clinical outcomes.

Transitional care programs have been developed to improve continuity of care and support patients during the transition from hospital to home. Structured transitional care interventions may enhance patients' self-efficacy and self-care abilities while reducing depressive symptoms.

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. Eligible participants will be randomly assigned to either the intervention group or the usual care group. The intervention group will receive a structured transitional care program in addition to usual care, whereas the control group will receive usual care only.

Outcomes including depression, self-efficacy, and self-care behaviors will be measured before discharge and at 1 and 3 months after discharge using validated assessment instruments.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Usual Care

Other

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

Primary outcomes

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

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

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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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