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临床试验/NCT05852509
NCT05852509
招募中
不适用

Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 32 人2024年7月1日

概览

阶段
不适用
干预措施
TPA4You
疾病 / 适应症
Heart Failure
发起方
University of Colorado, Denver
入组人数
32
试验地点
1
主要终点
Daily physical activity counts
状态
招募中
最后更新
3个月前

概览

简要总结

The purpose of the Aim 3 study is to conduct a pilot randomized controlled trial to assess feasibility and preliminary effects of the TPA4You intervention.

注册库
clinicaltrials.gov
开始日期
2024年7月1日
结束日期
2027年5月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Age greater than or equal to 50 years
  • Involved in caring for a household member aged 50 years or older with the New York Heart Association Class II, III or IV HF
  • Provide at least 8 hours/week of unpaid care for the past 3 months
  • Physically able to engage in structured exercise such as walking, and upper body resistance exercises
  • Engage in \< 30 min of moderate-intensity exercise on fewer than 3 days per week
  • Able to read, speak, and comprehend 5th grade English
  • Own a smartphone
  • Reachable by telephone, text messaging, and email
  • Have a 6x6ft space fit for physical activity in the place of residence

排除标准

  • Medical or functional conditions precluding participation in the physical activity (PA) components of the intervention (e.g., inability to walk one block or climb stairs without chest pain, shortness of breath, dizziness; history of falls; or serious or unstable cardiovascular or pulmonary disease)
  • Cognitive impairment (Telephone Interview for Cognitive Status \[TICS\] score \< 25)
  • Inability to use technology
  • Participation in a PA intervention in the previous 6 months
  • Current participation in a PA or behavior change trial
  • Physical activity unpreparedness ('Yes' to any questions 1-4 the Physical Activity Readiness Questionnaire \[PAR-Q\]. If participants respond 'yes' to any questions 5-7, we will ask follow-up questions.)

研究组 & 干预措施

TPA4You group

Participants in the TPA4You group will be given an overview of the TPA4You program and PA exercise safety instructions. HF-FCPs will receive 28 PA sessions delivered by the coach over 12 weeks. The coached sessions will taper from 3 days/week (weeks 1-4) to 2 days/week (weeks 5-12) but exercise on 3 days/week will be recommended throughout. Participants will receive tailored motivational text messages every other day to encourage daily exercise and wearing the Fitbit.

干预措施: TPA4You

Attention control group

Participants will be given booklets, provided by the NIA, AHA, and National Alliance for Caregiving that include content about self-care for FCPs' health and well-being, but not specific to PA or exercise. Participants will receive text messages every other day to encourage them to wear the Fitbit device, and to provide friendly greetings and reminders of upcoming survey data collection.

干预措施: Attention control group

结局指标

主要结局

Daily physical activity counts

时间窗: 6 months

Daily physical activity counts will be measured using the Fitbit Inspire 2 wearable wristband which is an accelerometer-based activity tracker. Total PA counts will be downloaded from the Fitbit app.

次要结局

  • Total sleep time(4 months)
  • Sedentary activity(6 months)
  • Physical function(6 months)
  • Depression(6 months)
  • Anxiety(6 months)
  • Stress(6 months)
  • Caregiving self-efficacy(6 months)
  • Health related quality of life(6 months)
  • Usability of TPA4You(6 months)
  • Wake after sleep onset(6 months)
  • Sleep efficiency(6 months)

研究点 (1)

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