NCT05852509 · University of Colorado, Denver
Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure
What this study is about
The purpose of the Aim 3 study is to conduct a pilot randomly assigned controlled trial to assess feasibility and preliminary effects of the TPA4You intervention.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
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.)
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations