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

17. juni 2026 oppdatert av: Hui-Shan Yeh, Chang Gung Memorial Hospital

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

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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

130

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Taoyuan City
      • Guishan, Taoyuan City, Taiwan, 33305
        • Chang Gung Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. juli 2023

Primær fullføring (Faktiske)

18. januar 2024

Studiet fullført (Faktiske)

25. juni 2024

Datoer for studieregistrering

Først innsendt

12. juni 2026

Først innsendt som oppfylte QC-kriteriene

17. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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