- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taoyuan City
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Guishan, Taoyuan City, 대만, 33305
- Chang Gung Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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