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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Caregiver Burden; Heart Failure

Treatments: Behavioral: Attention control group; Behavioral: TPA4You

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05852509

21-4757

K23AG073471 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 60 years
• Involved in caring for a household member aged 60 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

Exclusion criteria

• 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.)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

TPA4You group

Experimental group

Description:

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.

Treatment:

Behavioral: TPA4You

Attention control group

Other group

Description:

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.

Treatment:

Behavioral: Attention control group