- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07660237
Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure
Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure: A Randomized Controlled Trial
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Taoyuan City
-
Guishan, Taoyuan City, Taiwan, 33305
- Chang Gung Memorial Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Transitional Care Program Group
Participants received a structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
|
A structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
|
|
Aktiv komparator: Usual Care Group
Participants received routine discharge education and standard follow-up care provided by the hospital after dischar
|
Participants received standard discharge routine care provided by the hospital after discharge.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
Tidsram: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
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)
Tidsram: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
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)
Tidsram: 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).
|
Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202300968B0
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