Activity Tracking, Care Partner Co-participation, Text Reminders, Instructional Education, Video-Guided Physical Rehabilitation, and Exercise (ACTIVE) Intervention Among Older Adults With and Without Mild Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adoption
研究概览
简要总结
This is a multi-methods two-arm, crossover, analyst-blinded randomized controlled trial with embedded qualitative interviews, enrolling 50 dyads (older adult-care partner). Participants will receive the ACTIVE intervention, which includes a Fitbit smartwatch, motivational text messages to engage in walking exercise, instructional educational videos, and virtual physical therapy sessions. Intervention components will be delivered over 3 weeks, with continuous monitoring of physical activity via Fitbit data, read receipts of the motivational text messages, and log of engagement in the virtual physical therapy and educational videos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older Adults:
- •Age ≥65 years.
- •With or without mild dementia.
- •Willing to consent to participate in the study or have an LAR that is willing to consent for their participation in the study
- •Willing to wear a Fitbit smartwatch, receive text messages, watch intervention-related videos, participate in physical therapy, and walking exercise.
- •No contraindications to engaging in physical activity.
- •Care Partners:
- •Age ≥18 years.
- •Met criteria for survey participation.
- •Person being cared for is recruited in the study.
- •Willing to consent to participation
- •Willing to wear a Fitbit smartwatch, receive text messages, watch intervention-related videos, participate in physical therapy, and walking exercise.
- •No contraindications to engaging in physical activity.
排除标准
- •Older Adults:
- •Severe cardiac, neurologic, or musculoskeletal condition (including but not limited to recent or untreated fracture in any part of the body)
- •limiting participation in daily walking or Fitbit smartwatch use.
- •Moderate to severe dementia (using the clinical dementia rating scale of 2 or higher
- •Inability to operate or manage a Fitbit smartwatch device (even with care partner support).
- •No phone or phone not capable of receiving text messages or watching videos.
- •No internet for watching videos
- •Care Partners:
- •Severe cardiac, neurologic, or musculoskeletal condition limiting participation in daily walking or Fitbit smartwatch use.
- •Pregnant care partners
- •Any level of dementia or cognitive impairment among care partners
- •Inability to operate or manage a Fitbit smartwatch device.
- •Inability to co-participate in intervention tasks with older adult
- •No phone or phone not capable of receiving text messages or watching videos.
- •No internet for watching videos
研究组 & 干预措施
Intervention, then Control
Week 1 (Pre-Intervention): Participants will wear the Fitbit smartwatch during waking hours. Data collected during this week will serve as baseline and for troubleshooting technical issues.
Weeks 2-4 (Intervention): Participants will receive the ACTIVE intervention (Activity tracking, Care partner co-participation, Text reminders, Instructional education, Virtual physical therapy and Exercise).
Week 5 (Crossover/Washout): Participants will switch arms (intervention to control).
Weeks 6-8 (Control): Participants will continue in the control arm (Fitbit use only).
干预措施: ACTIVE Intervention (Behavioral)
Control, then Intervention
Week 1 (Pre-Control): Participants will wear the Fitbit smartwatch during waking hours. Data collected during this week will serve as baseline and for troubleshooting technical issues.
Weeks 2-4 (Control): Participants will continue in the control arm (Fitbit use only).
Week 5 (Crossover/Washout): Participants will switch arms (control to intervention).
Weeks 6-8 (Intervention): Participants will the ACTIVE intervention (Activity tracking, Care partner co-participation, Text reminders, Instructional education, Virtual physical therapy and Exercise).
干预措施: ACTIVE Intervention (Behavioral)
结局指标
主要结局
Adoption
时间窗: Up to Week 7 (End of Week 1 of Intervention Period)
Measured as the proportion of participants who initiate use of each intervention component: * Smartwatch: device activated and worn for ≥3 days during week 1. * Text reminders: ≥1 responses to text message opened/read in week 1. * Virtual PT videos: at least one session accessed in week 1, which will be tracked online through participant specific username. * Instructional education videos: at least one video accessed in week 1,which will be tracked online through participant specific username.
Feasibility: Smartwatch
时间窗: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Smartwatch: proportion of days with ≥8 hours of wear time (captured on Fitabase). * Text reminders: proportion of responses to text messages (captured on Fitabase) opened or acknowledged. * Virtual PT videos: proportion of assigned sessions completed (captured on myACTIVEsteps.com via username); feasibility target. * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Feasibility: Motivational Texts
时间窗: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Text reminders: proportion of responses to text messages (captured on Fitabase) opened or acknowledged. * Virtual PT videos: proportion of assigned sessions completed (captured on myACTIVEsteps.com via username); feasibility target. * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Feasibility: Virtual Physical Therapy
时间窗: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Virtual PT videos: proportion of assigned sessions completed (captured on myACTIVEsteps.com via username); feasibility target. * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Feasibility: Instructional Education Videos
时间窗: Up to Week 8
Measured as sustained engagement with each component during the 3-week intervention: * Instructional education videos: proportion of assigned videos completed (captured on myACTIVEsteps.com via username.
Acceptability: System Usability Scale (SUS)
时间窗: Up to Week 10
The SUS is a 10-item survey assessing the usability of a system. Each item is rated on a Likert scale from 1-5; the raw score is the sum of responses, which is transformed to a standardized score ranging from 0-100; higher scores indicate greater usability.
Acceptability: Perceived Usefulness (PU): Smartwatch
时间窗: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Usefulness (PU): Motivational Texts
时间窗: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Usefulness (PU): Instructional Education Videos
时间窗: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Usefulness (PU): Virtual Physical Therapy
时间窗: Up to Week 10
The PU survey is a 5-item assessment of perceived usefulness of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived usefulness.
Acceptability: Perceived Ease-of-Use (PEU): Smartwatch
时间窗: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Acceptability: Perceived Ease-of-Use (PEU): Motivational Texts
时间窗: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Acceptability: Perceived Ease-of-Use (PEU): Instructional Education Videos
时间窗: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Acceptability: Perceived Ease-of-Use (PEU): Virtual Physical Therapy
时间窗: Up to Week 10
The PEU survey is a 5-item assessment of perceived ease-of-use of technology. Each item is rated on a Likert scale from 1-7. The score is calculated as the average of responses and ranges from 1-7; higher scores indicate greater perceived ease-of-use.
Intervention Delivery Fidelity
时间窗: Up to Week 8.
Proportion of intervention components successfully delivered by study staff.
Participant Fidelity
时间窗: Up to Week 8.
Proportion of assigned intervention activities completed, verified via Fitbit logs, video analytics, and message tracking.
Change in Falls Efficacy Scale-International (FES-I) Score
时间窗: Baseline, Up to Week 10
FESI-I is a 16-item self-report questionnaire assessing older adults' fear about falling during daily activities. Each item is rated on a Likert scale from 1-4 (not at all to very concerned). The total score is the sum of responses and ranges from 16-64, where higher scores mean more fear and less confidence.
Change in Activities of Daily Living (ADL) Score
时间窗: Baseline, Up to Week 10
The ADL ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Participants are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Change in Instrumental Activities of Daily Living (IADL) Score
时间窗: Baseline, Up to Week 10
IADL is an 8-item assessment of independence in completing complex tasks. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Knowledge Score
时间窗: Baseline, Up to Week 10
The Knowledge subsection of the KAP survey comprises 20 items assessing knowledge of physical exercise. Each item is rated on a Likert scale from 1-5. The total score is the sum of responses and ranges from 20-100; higher scores indicate greater knowledge.
Change in Short Form - 12 Quality of Life Survey (SF-12)
时间窗: Baseline, Up to Week 10
The SF-12 is a 12-item assessment of quality of life. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses; the raw score is converted to a standardized score ranging from 0-100 with a mean of 50 and standard deviation of 10. Higher scores indicate greater quality of life.
Change in Knowledge, Attitude, and Practice (KAP) of Physical Exercise: Attitude Score
时间窗: Baseline, Up to Week 10
The Attitude subsection of the KAP survey comprises 10 items assessing attitude toward physical exercise. Each item is rated on a Likert scale from 1-5. The total score is the sum of responses and ranges from 10-50; higher scores indicate more positive attitude toward physical exercise.
次要结局
未报告次要终点