- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04143763
Mobile Message Intervention for Stroke Caregivers' Psychological Support
The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
연구 개요
상세 설명
75% of stroke caregivers report severe caregiver burdens, with 60% of stroke caregivers reporting at least one depressive symptom in Hong Kong. However, caregivers can experience difficulties in accessing and fully utilising existing services due to the varying types of care needs and its intensities amongst stroke survivors.
Ecological momentary intervention (EMI) as an innovative and personalised intervention has shown great potential in supporting psychological well-being; yet, there are no studies on using EMI for the caregivers' psychological support. The proposed trial aims to reduce stroke caregivers' psychological distress by delivering EMI through instant messaging applications to provide personalised and real-time support led by healthcare professionals.
Stroke caregivers screened by Patient Health Questionnaire-9 (PHQ-9) with scores ranging from 5 to 19 will be recruited from multiple sites including community centres, rehabilitation centres and outpatient clinics in public hospitals in Hong Kong, and individually randomised into the intervention group (n=20) or control group (n=20). The intervention group will receive the personalised instant messages for 4 weeks. The control group will receive general health information and regular messages reminding them to participate in follow-up surveys. The primary outcome will be the score of PHQ-9 at 4 weeks. Secondary outcomes will include anxiety, perceived stress, and caregiver burden.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hong Kong, 홍콩
- 모병
- Hong Kong PHAB Association
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연락하다:
- ADMIN ADMIN
- 전화번호: 26511468
- 이메일: jcfc@hkphab.org.hk
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Hong Kong, 홍콩
- 모병
- Hong Kong Stroke Association
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연락하다:
- Admin Admin
- 전화번호: 23078257
- 이메일: hk_stroke_a@yahoo.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Primary family caregiver of stroke survivor
- Able to read and communicate in Chinese
- Able to use mobile phone text messaging function
- PHQ-9 ranged from 5 to 19
Exclusion Criteria:
- Professional medical personnel and care assistants
- Has provided care for <1 month prior to recruitment
- Has diagnosis of psychiatric disease or is currently taking psychotropic drug
- PHQ-9 ≥ 20 (i.e., severe depressive symptom)
- Currently participating in any type of psychological support intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Intervention group
receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group.
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Using the messaging function of mobile devices, EMI offers a framework to deliver health information to the target population, corresponding to each individual's demands in terms of type (e.g., photo, text and/or voice message), timing, duration, and frequency of the messages, which are different to the features from other interventions
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간섭 없음: Control group
receive general health information through a mobile message.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks
기간: 4 weeks
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Patient Health Questionnaire (PHQ-9) Scale: PHQ-9 is a scale for screening depression in primary care.
It consists of 9 items with 4 likert scale.
Score range is from 0 to 27 (higher score = higher severity of depressive symptom).
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4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks
기간: 4 weeks
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Generalized Anxiety Disorder-7 (GAD-7) Scale: GAD-7 is a scale for screening anxiety in primary care. It consists of 7 items with 4 likert scale. Score range is from 0 to 21 (higher score = higher severity of anxiety symptom). |
4 weeks
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Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks
기간: 4 weeks
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Perceived Stress Scale (PSS-4); PSS-4 is a scale for screening stress level.
It consists of 4 items with 5 likert scale.
Score range is from 0 to 16 (higher score = higher severity of stress).
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4 weeks
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Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks
기간: 4 weeks
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Burden Interview-4 (ZBI-4) Scale: ZBI-4 is a scale for screening carer's burdens. It consists of 4 items with 5 likert scale. Score range is from 0 to 16 (higher score = higher severity of caring burden). |
4 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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. .