Rural Veteran and Care Partner Walking Program
Remotely Improving Physical Activity in Rural Veterans With Cognitive Impairment and Care Partner Dyads
The purpose of this study is to determine the practicality/feasibility of a virtual physical activity intervention to improve daily steps for Veterans with mild cognitive impairment and their care partners living in rural areas.
Participation includes:
- Complete a 6-week walking program
- Complete 2 testing visits (1 before and 1 after the 6-week walking program) consisting of various surveys and questionnaires
- Complete a semi-structured interview on feasibility and feedback of the intervention
- Potentially serve on an advisory board with the research team to assist with implementing the walking program adaptations
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rashelle Hoffman, PT, DPT, PhD
- 전화번호: 402-280-5691
- 이메일: rashellehoffman@creighton.edu
연구 장소
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Nebraska
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Omaha, Nebraska, 미국, 68178
- 모병
- Creighton University
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연락하다:
- Rashelle Hoffman, PT, DPT, PhD
- 전화번호: 402-280-5691
- 이메일: rashellehoffman@creighton.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for Veterans:
- 60-95 years of age
- Mild cognitive impairment as staged by Clinical Dementia Rating (CDR, a gold standard cognitive outcome in ADRD clinical research) score of 0.5 or equivalent
- Characterized as underactive by the Telephone Assessment of Physical Activity (TAPA)
- Have a care partner willing to participate in physical activity and assist the participant
- Own a smartphone or tablet and willing to download a fitness tracker application
- Live in a rural area according to the VA Office of Rural Health rurality calculator
Inclusion Criteria for Veterans & Care Providers:
- No self-reported falls in the last year
- Able to walk across a room in the home with no assistive device(s)
- Stable doses of medication over the previous 30 days
- Pass the Physical Activity Readiness Questionnaire+ (answering "no" to questions are pages 1-3)
- Interaction as a dyad (Veteran and care partner) at least on a weekly basis
Inclusion Criteria for Veterans & Care Providers:
- 19 years of age or older
- No cognitive impairment as indicated by a score of < 1 on the AD8 Dementia Screening Interview
Exclusion Criteria for Veterans & Care Providers:
- Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Field Testing Group
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Six dyads (n=12) will complete TPAB field testing and will undergo testing at baseline and post-intervention. Consent, baseline testing, intervention delivery, and post-testing will be conducted virtually via Microsoft Teams and data recorded in VA REDCap. Testing sessions will not be recorded, with the exception of semi-structured interviews during post-testing. The testing procedures will take approximately 2 hours to complete at each testing time point. The TPAB intervention will involve weekly 30-minute sessions with study personnel for 6 weeks. Due to the 7-day activity monitor data collection prior to and following the 6-week TPAB intervention, participants will be enrolled in the study for approximately 8 weeks. Three dyads will be asked to join the advisory board with the research team to assist with implementing the walking program adaptations based on the collective feedback across the 16 dyads. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Weekly Session Attendance
기간: From enrollment to end of the 6-week intervention
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The total number of sessions attended by dyads will be reported as a percentage of the 6 weekly sessions. Ranges of attendance could be 0% (not attending any sessions) to 100% attending all session. Attendance will be used to evaluate participant engagement and practicality of implementation. |
From enrollment to end of the 6-week intervention
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Study Retention
기간: From enrollment to end of intervention at 8 weeks
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Defined as continued participation through the study completion. Calculated using withdrawal and completion records. Higher retention (such as 100% retention indicating all dyads that enrolled in the study, completed the study) supports intervention feasibility. |
From enrollment to end of intervention at 8 weeks
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Intrinsic Motivation Inventory (IMI)
기간: Post-intervention (week 8)
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Evaluates participant interest, enjoyment, perceived value, and engagement with the intervention. The IMI is comprised of 7 statements related to interest/enjoyment that the participant indicates how true the statement is to them regarding their experience participating in the intervention. Each statement is scored on a 1-7 scale and an average is computed across all the questions to determine the IMI score. Higher scores indicate greater intervention acceptability. |
Post-intervention (week 8)
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Number of participants with study-related adverse events
기간: From enrollment to end of intervention at 8 weeks
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Includes falls, injuries, medical issues, skin irritation, or other unintended consequences. Used to evaluate intervention safety. |
From enrollment to end of intervention at 8 weeks
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Average Daily Stepping
기간: Pre (before starting the 6-week walking program) and Post Intervention (following completion of the 6-week walking program)
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Objective measure of physical activity captured through Fitbit devices. Average daily step counts are computed in the Fitbit application and will be recorded for each day and averaged over the 7-day monitoring period before and after the intervention provide proof-of-concept evidence of behavior change. |
Pre (before starting the 6-week walking program) and Post Intervention (following completion of the 6-week walking program)
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Qualitative Intervention Feasibility Outcomes
기간: Post-intervention (for feedback)
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Interviews evaluating demand, implementation, practicality, acceptability, adaptation, and integration. Findings will guide refinement of the intervention for future trials. |
Post-intervention (for feedback)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 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. .