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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Taoyuan City
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Guishan, Taoyuan City, Taiwan, 33305
- Chang Gung Memorial Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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A structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
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Actieve vergelijker: Usual Care Group
Participants received routine discharge education and standard follow-up care provided by the hospital after dischar
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Participants received standard discharge routine care provided by the hospital after discharge.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
Tijdsspanne: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
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Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES)
Tijdsspanne: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES).
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Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI)
Tijdsspanne: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Self-care behaviors will be assessed using the Self-Care of Heart Failure Index (SCHFI).
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Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 202300968B0
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Structured Transitional Care Program
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Chulalongkorn UniversityQueen Sirikit National Institute of Child Health (QSNICH), ThailandVoltooidGezond | Te vroeg geboren neonaat | Neonatale Intensive CareThailand