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Rural Veteran and Care Partner Walking Program

2026年10月29日 更新者:Creighton University

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

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Nebraska
      • Omaha、Nebraska、美国、68178

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Weekly Session Attendance
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月12日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年6月16日

首先提交符合 QC 标准的

2026年10月29日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2025年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • Creighton IRB: 2005570

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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