Heart Failure and Reduced Ejection Fraction, Transitional Care
Conditions
Keywords
Depression, Self-Efficacy, Self-Care
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.
Detailed description
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.
Interventions
BEHAVIORALStructured Transitional Care Program
A structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
OTHERUsual Care
Participants received standard discharge routine care provided by the hospital after discharge.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the behavioral and nursing intervention, participants and investigators will not be blinded to group assignment.
Intervention model description
Participants will be randomly assigned to either the structured transitional care program group or the usual care group in a parallel design.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9) | Baseline (before discharge), 1 month after discharge, and 3 months after discharge. | Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). |
| Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES) | Baseline (before discharge), 1 month after discharge, and 3 months after discharge. | Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES). |
| Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI) | 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). |
Countries
Taiwan
Outcome results
None listed