Cardiac RehabilitationNCT05795036
Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients
A study testing mHealth 1 and mHealth 2 in people with Cardiac Rehabilitation and Physical Activity, run by AdventHealth University at 1 site in United States.
Trial summary
In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Rehabilitation, Physical Activity
- What is being tested?
- mHealth 1 and mHealth 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently receiving Phase III CR at Hope Clinic
- are 18 years of age or older
- can read and communicate in English
- able to follow instructions to walk
- provided signed informed consent
- willing to wear Fitbit throughout the study
- owns a smartphone with text messaging capability (participants need to decide ahead of time if they have a phone plan that is compatible with taking additional text messages without undue financial burden for themselves)
- willing to receive text messages and phone calls from the research team.
Who cannot join
- are pregnant or lactating
- have scheduled surgery or traveling within the next 8 weeks
- currently participating in other health promotion program
- sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat overly active").
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
AdventHealth University
Orlando, Florida, 32803
Leana Goncalves Araujo
About this study
In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:
- Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
- Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.
Read the detailed description
In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the clients' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:
- Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
- Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.
- Conditions
- Cardiac Rehabilitation, Physical Activity
- Being tested
- mHealth 1, mHealth 2
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth 1Device
Participants will use Fitbit device to self-monitor their physical activity in 8 weeks.
mHealth 2Device
Participants will use Fitbit device to self-monitor their physical activity in 8 weeks. In addition, they will receive daily motivational text message.
| Study group | Role | What they receive |
|---|---|---|
| Hope Clinic | Experimental | Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission. Receives: Device: mHealth 1; Device: mHealth 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clients' demographic information will be obtained using a paper questionnaire administered at screening phase
Descriptive statistics will be used to assess completeness of study data, normality of outcome measures, and potential covariates, and to identify potential covariate imbalances between study arms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start17 Feb 2023
- Primary completion17 Aug 2025 (estimated)
- Study completion17 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Wei Fan, AdventHealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795036
- Sponsor's protocol ID
- 1848850-2
- Status last verified
- Jul 2024
- First submitted
- 21 Mar 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients
- ClinicalTrials.gov ID
- NCT05795036
- Acronym / sponsor ID
- 1848850-2
- Conditions
- Cardiac Rehabilitation, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- AdventHealth UniversityUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 17 Aug 2025 (estimated)
- Study completion
- 17 Dec 2025 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:
- Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
- Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.
Detailed description
In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the clients' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:
- Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
- Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hope Clinic | Experimental | Device: mHealth 1, Device: mHealth 2Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- currently receiving Phase III CR at Hope Clinic
- are 18 years of age or older
- can read and communicate in English
- able to follow instructions to walk
- provided signed informed consent
Key exclusion criteria (4 listed)
- are pregnant or lactating
- have scheduled surgery or traveling within the next 8 weeks
- currently participating in other health promotion program
- sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat overly active").
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth 1Participants will use Fitbit device to self-monitor their physical activity in 8 weeks. | Device | Hope Clinic |
| mHealth 2Participants will use Fitbit device to self-monitor their physical activity in 8 weeks. In addition, they will receive daily motivational text message. | Device | Hope Clinic |
Primary outcome
Clients' demographic information will be obtained using a paper questionnaire administered at screening phase
Time frame: 12 months
Descriptive statistics will be used to assess completeness of study data, normality of outcome measures, and potential covariates, and to identify potential covariate imbalances between study arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth 1 and mHealth 2 in people with Cardiac Rehabilitation and Physical Activity, run by AdventHealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Wei Fan, MD (407-609-1388, chia-wei.fan@ahu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clients' demographic information will be obtained using a paper questionnaire administered at screening phase (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.