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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG073471 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPA4You group | Experimental | 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. |
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| Attention control group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPA4You | Behavioral | TPA4You integrates technology components in the form of video-conferencing (e.g., Zoom) with a health coach, wearable sensor (e.g., Fitbit), and personalized text messaging into a package to (a) tailor physical activity (PA) prescriptions based on the family care partners of persons with heart failure (HF-FCP)'s feedback and individual wearable sensor data, (b) provide tailored PA coaching sessions using video-conferencing, and (c) motivate daily exercise using text messages. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily physical activity counts | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary activity | Sedentary activity will be measured using the Fitbit Inspire 2 wearable wristband which is an accelerometer-based activity tracker. The data will be downloaded from the Fitbit app. Sedentary activity is defined as less than 100 counts/min. | 6 months |
| Physical function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawon Baik, PhD | Contact | 3037241263 | dawon.baik@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dawon Baik, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41631240 | Derived | Baik D, Coats H, Reeder B, Allen LA, Jankowski C. Digital health physical activity coaching for older family caregivers of persons with heart failure - TPA4You: Protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2026 Jan 20;49:101604. doi: 10.1016/j.conctc.2026.101604. eCollection 2026 Feb. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000084802 | Caregiver Burden |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
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| Attention control group | Behavioral | 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. |
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30-Second Chair Stand Test will be used to assess lower-body strength. The coach will explain the test to participants and measure performance. Participants will sit squarely in a stable chair with arms crossed over chest, and, with a straight back rise to a full standing position without use of hands, return to the seated position and repeat for 30 seconds. |
| 6 months |
| Depression | Depression will be measured using the Center for Epidemiological Studies Depression Scale (CES-D), a 20-item questionnaire rated on a 4-point Likert scale ranging from 0 to 3 (higher scores = worse depressive symptom). | 6 months |
| Anxiety | Anxiety will be measured using the State Trait Anxiety Index, a 20-item questionnaire rated on a 4-point scale with total scores from 1 to 80 (higher scores = worse anxiety symptom). | 6 months |
| Stress | Stress will be measured using the Perceived Stress Scale (PSS), a 10-item questionnaire rated on a 5-point Likert scale ranging from 0 to 4 (higher scores = worse stress). | 6 months |
| Caregiving self-efficacy | Caregiving self-efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy (RSCSE), a 15-item questionnaire rated on an 11-point scale ranging from 0 to 100 (higher scores = better self-efficacy). | 6 months |
| Health related quality of life | Health related quality of life (HRQoL) will be measured using the Short Form 36 version 2,a 36-item questionnaire with 2 domains (physical and psychological health) (higher scores = better HRQoL). | 6 months |
| Usability of TPA4You | Self-reported ease of use and usability of TPA4You will be measured with the refined 20-item Health Information Technology (IT) Usability Evaluation Scale (Health-ITUES) (higher scores = better usability). | 6 months |
| Total sleep time | Total sleep time will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app. | 4 months |
| Wake after sleep onset | Wake after sleep onset will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app. | 6 months |
| Sleep efficiency | Sleep efficiency will be measured using the Fitbit Inspire 2 wearable wristband and collected from the Fitbit app. | 6 months |
| D001519 |
| Behavior |