- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05403021
Piloting GETCare: A Remote Goal-based Education and Skills Training Program for Caregivers Poststroke (GETCare)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Utah
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Salt Lake City, Utah, 미국, 84112
- University of Utah
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- self-identification as a primary caregiver (direct care involvement) of someone who had a stroke (no restriction on stroke duration)
- ≥ 18 years old
- access to internet/telephone throughout the study
- able to speak, read, and understand English
- person with stroke expected to discharge within 1 month if still in the hospital
Exclusion Criteria:
- unable to read and follow basic instructions
- indicated the individual with stroke had no deficits poststroke
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: GETCare Intervention
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This 5-week intervention was administered remotely and individually to caregivers utilizing phone, email, and a secure online platform.
The GETCare program was mostly self-led and included five weekly module education topics: basics of stroke, caregiver skills, caregiver changes, meaningful participation, and community resources.
Each module incorporated (1) individualized education, (2) goal setting, (3) skills training, and (4) community resource recommendations.
The program was led by a licensed occupational therapist who is a certified stroke rehabilitation specialist.
The occupational therapist conducted weekly check-ins via email or phone focused on answering questions, tracking goal progress, and assisting in problem solving.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Perceived Stress Scale
기간: Baseline
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Scores range 0-40, higher score indicates higher perceived stress
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Baseline
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Perceived Stress Scale
기간: Post-intervention (approximately 6 weeks)
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Scores range 0-40, higher score indicates higher perceived stress
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Post-intervention (approximately 6 weeks)
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Revised Scale for Caregiving Self-efficacy
기간: Baseline
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Scores range 0-100, higher score indicates higher self-efficacy
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Baseline
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Revised Scale for Caregiving Self-efficacy
기간: Post-intervention (approximately 6 weeks)
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Scores range 0-100, higher score indicates higher self-efficacy
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Post-intervention (approximately 6 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Modified Caregiver Strain Index
기간: Baseline
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Scores range 0-26, higher score indicates higher caregiver strain
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Baseline
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Modified Caregiver Strain Index
기간: Post-intervention (approximately 6 weeks)
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Scores range 0-26, higher score indicates higher caregiver strain
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Post-intervention (approximately 6 weeks)
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Patient-Reported Outcomes Measurement Information System-43 Profile v2.1
기간: Baseline
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43 items across seven domains: physical function, anxiety, fatigue, depression, sleep disturbance, ability to participate in social roles and activities, and pain interference; Scores range 6-30 for each subscale. For subscales of anxiety, depression, fatigue, and sleep disturbance, higher scores indicate worse symptoms. For subscale of social participation, higher scores indicate improved symptoms. Subscales of physical function and pain interference were not included in analyses, since they were not expected to change through this intervention. |
Baseline
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Patient-Reported Outcomes Measurement Information System-43 Profile v2.1
기간: Post-intervention (approximately 6 weeks)
|
43 items across seven domains: physical function, anxiety, fatigue, depression, sleep disturbance, ability to participate in social roles and activities, and pain interference; Scores range 6-30 for each subscale. For subscales of anxiety, depression, fatigue, and sleep disturbance, higher scores indicate worse symptoms. For subscale of social participation, higher scores indicate improved symptoms. Subscales of physical function and pain interference were not included in analyses, since they were not expected to change through this intervention. |
Post-intervention (approximately 6 weeks)
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Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being v1.0
기간: Baseline
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9 items; Scores range 9-45, higher score indicates higher positive affect and well-being
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Baseline
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Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being
기간: Post-intervention (approximately 6 weeks)
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9 items; Scores range 9-45, higher score indicates higher positive affect and well-being
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Post-intervention (approximately 6 weeks)
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Knowledge assessment
기간: Baseline
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Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge
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Baseline
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Knowledge assessment
기간: Post-intervention (approximately 6 weeks)
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Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge
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Post-intervention (approximately 6 weeks)
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Canadian Occupational Performance Measure
기간: Baseline
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Assesses importance of goal, current performance of goal, and satisfaction with current performance of goal; Scores range 0-10, higher score indicates higher importance, performance, and satisfaction with performance
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Baseline
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Canadian Occupational Performance Measure
기간: Post-intervention (approximately 6 weeks)
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Assesses importance of goal, current performance of goal, and satisfaction with current performance of goal; Scores range 0-10, higher score indicates higher importance, performance, and satisfaction with performance
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Post-intervention (approximately 6 weeks)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Feedback survey
기간: Post-intervention (approximately 6 weeks)
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Included a variety of questions (no/yes, Likert scales, and open-ended questions) regarding feedback of the intervention.
For example, "Please indicate how helpful the additional handouts and videos were for you" (0 = not at all helpful, 1 = a little helpful, 2 = somewhat helpful, 3 = quite helpful, 4 = extremely helpful).
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Post-intervention (approximately 6 weeks)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jackie Einerson, MOT, University of Utah
간행물 및 유용한 링크
일반 간행물
- Einerson, J., & Terrill, A. (2019). GETCare: Development of a Comprehensive Education and Training Program For Care-Partners Post-Stroke. Archives of Physical Medicine and Rehabilitation, 100(10), e8. https://doi.org/https://doi.org/10.1016/j.apmr.2019.08.012
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. .
GETCare Intervention에 대한 임상 시험
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