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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual Care Group | Active Comparator | Participants received routine discharge education and standard follow-up care provided by the hospital after dischar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Guishan | Taoyuan City | 33305 | Taiwan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2023 | May 21, 2026 |
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Participants will be randomly assigned to either the structured transitional care program group or the usual care group in a parallel design.
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Due to the nature of the behavioral and nursing intervention, participants and investigators will not be blinded to group assignment.
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| Usual Care | Other | Participants received standard discharge routine care provided by the hospital after discharge. |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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