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
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rashelle Hoffman, PT, DPT, PhD
- 電話番号：402-280-5691
- メール：rashellehoffman@creighton.edu
研究場所
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-
Nebraska
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Omaha、Nebraska、アメリカ、68178
- 募集
- Creighton University
-
コンタクト：
- Rashelle Hoffman, PT, DPT, PhD
- 電話番号：402-280-5691
- メール：rashellehoffman@creighton.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Field Testing Group
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weekly Session Attendance
時間枠：From enrollment to end of the 6-week intervention
|
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
|
|
Study Retention
時間枠：From enrollment to end of intervention at 8 weeks
|
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
|
|
Intrinsic Motivation Inventory (IMI)
時間枠：Post-intervention (week 8)
|
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)
|
|
Number of participants with study-related adverse events
時間枠：From enrollment to end of intervention at 8 weeks
|
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
|
|
Average Daily Stepping
時間枠：Pre (before starting the 6-week walking program) and Post Intervention (following completion of the 6-week walking program)
|
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)
|
|
Qualitative Intervention Feasibility Outcomes
時間枠：Post-intervention (for feedback)
|
Interviews evaluating demand, implementation, practicality, acceptability, adaptation, and integration. Findings will guide refinement of the intervention for future trials. |
Post-intervention (for feedback)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。