- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07690280
Web-Based Psychoeducation for Dementia Caregivers
A Web-Based Psychoeducation and Symptom-Monitoring Program to Enhance Dementia Caregiver Self-Efficacy in Managing BPSD
Behavioral and psychological symptoms of dementia (BPSD), such as agitation, anxiety, depression, sleep disturbance, and apathy, are common among people with dementia and often increase the burden on family caregivers. Many caregivers have limited knowledge and confidence in managing these symptoms.
This study aims to evaluate the effectiveness of a 6-week web-based psychoeducation and BPSD symptom-monitoring program in improving caregivers' self-efficacy in managing BPSD. Community-dwelling family caregivers of people with dementia will be recruited from the neurology outpatient clinic of Lotung Poh-Ai Hospital in Taiwan.
Participants will be assigned sequentially to either an intervention group receiving web-based psychoeducation, BPSD symptom monitoring, and usual care, or a control group receiving usual care alone. The primary outcome is caregiver self-efficacy. Secondary outcomes include BPSD severity and caregiver burden.
연구 개요
상세 설명
Behavioral and psychological symptoms of dementia (BPSD) affect most people living with dementia during the course of the disease and are associated with increased caregiver burden, psychological distress, and reduced quality of life. Family caregivers frequently experience difficulties in recognizing BPSD, identifying possible triggers, and applying appropriate management strategies. Although web-based psychoeducation has shown potential benefits for dementia caregivers, evidence regarding its effectiveness in improving caregiver self-efficacy through the integration of structured symptom monitoring remains limited.
This study will evaluate a six-week web-based psychoeducation and BPSD symptom-monitoring program developed for family caregivers of community-dwelling people with dementia. The intervention is delivered through an AppSheet-based online platform and includes six educational modules, BPSD symptom diary recording based on the Neuropsychiatric Inventory Questionnaire (NPI-Q), weekly reminders, and online support when needed. Educational topics include understanding dementia and BPSD, symptom recognition, communication strategies, daily care, caregiver self-care, and community support resources.
This study uses a quasi-experimental two-group pretest-posttest parallel design. Approximately 80 family caregivers will be recruited from the neurology outpatient clinic of Lotung Poh-Ai Hospital, Taiwan. Participants will be assigned sequentially in alternating order to either the intervention group or the usual care control group.
Outcome assessments will be conducted at baseline (Week 0) and immediately after the six-week intervention (Week 6) for both groups. Participants in the intervention group will additionally complete a follow-up assessment at Week 10 to evaluate maintenance of intervention effects.
The primary outcome is caregiver self-efficacy measured using the Revised Scale for Caregiving Self-Efficacy (RSCSE). Secondary outcomes include BPSD severity measured using the Neuropsychiatric Inventory Questionnaire (NPI-Q) and caregiver burden measured using the Zarit Burden Interview (ZBI-22).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shan-Hua Chen
- 전화번호: 5430 +88639543131
- 이메일: c887034@mail.pohai.org.tw
연구 장소
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Yilan County
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Luodong, Yilan County, 대만, 265
- 모병
- Lotung Poh-Ai Hospital
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연락하다:
- Shan-Hua Chen
- 전화번호: 5430 +88639543131
- 이메일: c887034@mail.pohai.org.tw
-
수석 연구원:
- Shan-Hua Chen
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Family caregivers aged 20 to 90 years.
- The primary caregiver of a community-dwelling person diagnosed with dementia.
- Able to read and understand Chinese.
- Able to use a smartphone, tablet, or computer with Internet access.
- Willing to provide written informed consent and comply with study procedures.
Exclusion Criteria:
- Caregivers of persons with dementia who reside in a long-term care institution.
- Unable to complete study procedures because of cognitive, physical, or communication impairment.
- Currently participating in another intervention study that may influence the study outcomes.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Group
Participants receive a 6-week web-based psychoeducation and symptom-monitoring program in addition to usual care.
The intervention includes six web-based educational modules, BPSD symptom monitoring, weekly reminders, and online consultation when needed.
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Participants assigned to the intervention group receive a 6-week web-based psychoeducation and symptom-monitoring program in addition to usual care.
The program includes six web-based educational modules on dementia care, BPSD symptom monitoring, weekly reminders to support engagement, and online consultation with the research team when needed.
The intervention is designed to improve caregiver self-efficacy in managing behavioral and psychological symptoms of dementia.
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간섭 없음: Control Group
Participants receive usual care without access to the web-based psychoeducation and symptom-monitoring program during the study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Caregiver Self-Efficacy in Managing Behavioral and Psychological Symptoms of Dementia
기간: Baseline and Week 6
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Caregiver self-efficacy will be assessed using the Revised Scale for Caregiving Self-Efficacy (RSCSE).
The primary outcome is the change in caregiver self-efficacy from baseline to Week 6 between the intervention and control groups.
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Baseline and Week 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Behavioral and Psychological Symptoms of Dementia
기간: Baseline and Week 6
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Behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q).
The secondary outcome is the change in symptom severity and caregiver distress from baseline to Week 6 between the intervention and control groups.
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Baseline and Week 6
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Caregiver Burden
기간: Baseline and Week 6
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Caregiver burden will be assessed using the 22-item Zarit Burden Interview (ZBI-22).
The secondary outcome is the change in caregiver burden from baseline to Week 6 between the intervention and control groups.
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Baseline and Week 6
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shan-Hua Chen, Lotung Poh-Ai Hospital
간행물 및 유용한 링크
일반 간행물
- Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369.
- Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. doi: 10.1093/geronb/57.1.p74.
- Yu Y, Xiao L, Ullah S, Meyer C, Wang J, Pot AM, He JJ. The effectiveness of internet-based psychoeducation programs for caregivers of people living with dementia: a systematic review and meta-analysis. Aging Ment Health. 2023 Sep-Oct;27(10):1895-1911. doi: 10.1080/13607863.2023.2190082. Epub 2023 Mar 23.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- LOPAH-BPSD-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
백치에 대한 임상 시험
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ACADIA Pharmaceuticals Inc.모병Lewy Body Dementia Psychosis미국, 체코, 세르비아, 프랑스, 불가리아, 이탈리아
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ACADIA Pharmaceuticals Inc.초대로 등록