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Can a fitbit and coaching help older caregivers get moving?

NCT ID NCT05852509

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests a digital program called TPA4You for older adults (50+) who care for a family member with heart failure. The program uses a Fitbit, video coaching, and text messages to encourage physical activity. The goal is to see if it's feasible and helps improve caregivers' daily activity and well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention: digital health physical activity program (TPA4You) with health coaching, wearable sensor, and text messaging
What this could lead to
If it works, this could point toward a simple, home-based way to improve physical activity and reduce stress for older caregivers of heart failure patients.
What could go wrong
This is a very small pilot study with only 32 participants, so results may not apply to all caregivers. The program requires a Fitbit and internet access, which may limit who can use it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.)

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Conditions

The condition(s) this trial relates to.

Caregiver Burden heart failure Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Caregiver burden Heart failure

Contacts and locations

Locations

  • University of Colorado

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.