Heart DiseasesVALENTINENCT04587882
Virtual AppLication-supported ENvironment To INcrease Exercise During Cardiac Rehabilitation Study
A study testing Telehealth in people with Heart Diseases and Cardiovascular Diseases, run by University of Michigan at 2 sites in United States.
Trial summary
The researchers are trying to determine whether a smartwatch and a mobile application, which together deliver activity and goal setting notifications, can increase activity levels for patients enrolled in cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Diseases, Cardiovascular Diseases
- What is being tested?
- Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2020to 25 Oct 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2013. Spectrum Health patients may participate if they have a Michigan Medicine MRN and data is available through connected electronic health records.
- Age > 18 and < 75
- Owns an Android or iPhone with study supported operating software.
- Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications.
- Enrolled in cardiac rehabilitation within the past 8-weeks based on one of the following indications (listed below) and has completed at least 2 cardiac rehabilitation sessions (includes orientation session; to remain in the study, participants in the hybrid program must complete at least one additional exercise session for a minimum of 2 center-based rehabilitation sessions):
- Coronary artery disease (including acute coronary syndromes and stable angina) following percutaneous coronary intervention (PCI)
Show all 9Show fewer
- Coronary artery disease following coronary artery bypass surgery (CABG)]
- Valve repair or replacement (either surgical or percutaneous)
- Coronary artery disease or an acute coronary syndrome not requiring revascularization
Who cannot join
- Orthopedic or neurological condition limiting ability to actively engage in exercise training session
- Greater than mild cognitive impairment
- Wrist too large to wear a smartwatch comfortably. This will be assessed by asking participants "If they have ever had difficulty wearing a watch in the past due to the band being too small."
- Currently receiving palliative care and/or in hospice care
- Severe valvular stenosis or regurgitation
- Unrevascularized left main coronary artery disease (> 50% obstruction on angiography) or proximal left anterior descending disease (>70% obstruction on angiography).
Show all 12Show fewer
- Exercise-induced ventricular tachycardia
- Cardiac arrest within the prior 6 months
- New York Heart Association (NYHA) class III or IV heart failure
- Pulmonary arterial hypertension treated with inhaled or intravenous pulmonary hypertension-specific therapy
- Ejection fraction <40%
- Determined to be unsafe for participation in this program to augment cardiac rehabilitation as assessed by a clinical nurse or investigative team.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Spectrum Health
Grand Rapids, Michigan, 49525
About this study
The researchers are trying to determine whether a smartwatch and a mobile application, which together deliver activity and goal setting notifications, can increase activity levels for patients enrolled in cardiac rehabilitation.
Read the detailed description
The VALENTINE Cardiac Rehabilitation Study will evaluate a digital intervention to supplement cardiac rehabilitation for low- and moderate risk patients, integrating a mobile application with physiologic and contextual information from wearables to provide incremental support to patients. The study will be performed in conjunction with planned home-, hybrid-, or center-based cardiac rehabilitation at Michigan Medicine. Participants will be randomized to the control or telehealth group. Both groups will receive a smartwatch and usual care. Participants in the telehealth arm will additionally (1) have access to activity tracking and goal setting through the VALENTINE app; (2) receive micro-randomized, contextually tailored notifications, and (3) receive weekly activity summaries via email, which will also be provided to their exercise physiologist while enrolled in cardiac rehabilitation. Contextually tailored notifications will be one of two types: walking and exercise notifications. Walking notifications are designed to encourage participants to be active though at lower than their target heart rate zone. Participants will receive 1 notification per day, on average, at one of four times. Notifications will be randomized on four dimensions of context. Exercise notifications are designed to encourage participants to exercise within their target heart rate zone. Notifications will be delivered each evening at a time of the participant's choosing. Participants will have a 50% probability of receiving a notification each evening. Notifications will be randomized on two dimensions of context. Participants will be followed for 6-months. Participants in both arms will be asked to complete a 6-minute walk test at baseline, 3-months, and 6-months using their mobile phone and smartwatch. They will additionally complete general and disease-specific quality-of-life questionnaires at baseline and at 6-months.
To account for potential measurement error between devices, for primary and secondary analyses, we will perform regression analysis to jointly test the null hypothesis H0: B0(F) = B0(A) = 0 for change between baseline and 6 months where (F) and (A) refer to Fitbit and Apple watches respectively. A secondary analysis will subsequently be performed to determine whether to reject the individual null hypotheses for each of the two devices. For all statistical analyses, the level of significance will be set at p <0.05.
- Conditions
- Heart Diseases, Cardiovascular Diseases
- Being tested
- Telehealth, Control
- Keywords
- Cardiac rehabilitation
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthBehavioural
Participants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors.
ControlBehavioural
Participants will get usual care and wear a smartwatch.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth | Experimental | Participants will be provided with a smartwatch, have access to activity tracking and goal setting through the VALENTINE app, receive micro-randomized, contextually tailored notifications, and receive weekly activity summaries via email, which will be provided to participants and to their exercise physiologist while enrolled in cardiac rehabilitation. Receives: Behavioral: Telehealth |
| Control | Active comparator | Participants will continue to receive usual care and a smartwatch but without access to the micro-randomized notifications or weekly activity summaries. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walk distance
6-minute walk distance is determined by the 6-minute walk test recorded using a mobile phone paired with a smartwach and recorded in meters.
Measured: Baseline, 6-months
Secondary outcomes (1)
Change in average step count
Change in average step count as determined by smartwatch. Baseline average is the average step count from the first 7 days of wearing the smartwatch. The 6-month average step count is the daily average step count over one week at 6-months.
Measured: Baseline, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start23 Oct 2020
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized-controlled trial where the primary purpose is secondary prevention.
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health West
- Responsible party
- Principal investigator, Brahmajee K Nallamothu, University of Michigan
- Investigators
- Brahmajee K Nallamothu, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587882
- Sponsor's protocol ID
- HUM00162365
- Acronym
- VALENTINE
- Status last verified
- Nov 2022
- First submitted
- 6 Oct 2020
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atluri N, Gupta K, Basu T, Luff E, Shi J, Boyden T, Mukherjee B, Kheterpal S, Klasnja P, Dempsey W, Nallamothu BK, Golbus JR. Characteristics of Tailored Text Messages Associated With Increased Physical Activity Among Cardiac Rehabilitation Enrollees: Secondary Analysis of a Microrandomized Trial. JMIR Mhealth Uhealth. 2026 Aug 11;14:e79792. doi: 10.2196/79792.
PubMed 42580690Golbus JR, Shi J, Gupta K, Stevens R, Jeganathan VSE, Luff E, Boyden T, Mukherjee B, Kohnstamm S, Taralunga V, Kheterpal V, Kheterpal S, Resnicow K, Murphy S, Dempsey W, Klasnja P, Nallamothu BK. Text Messages to Promote Physical Activity in Patients With Cardiovascular Disease: A Micro-Randomized Trial of a Just-In-Time Adaptive Intervention. Circ Cardiovasc Qual Outcomes. 2024 Jul;17(7):e010731. doi: 10.1161/CIRCOUTCOMES.123.010731. Epub 2024 Jun 18.
PubMed 38887953Atluri N, Mishra SR, Anderson T, Stevens R, Edwards A, Luff E, Nallamothu BK, Golbus JR. Acceptability of a Text Message-Based Mobile Health Intervention to Promote Physical Activity in Cardiac Rehabilitation Enrollees: A Qualitative Substudy of Participant Perspectives. J Am Heart Assoc. 2024 Jan 16;13(2):e030807. doi: 10.1161/JAHA.123.030807. Epub 2024 Jan 16.
PubMed 38226512Golbus JR, Gupta K, Stevens R, Jeganathan VS, Luff E, Boyden T, Mukherjee B, Klasnja P, Kheterpal S, Kohnstamm S, Nallamothu BK. Understanding Baseline Physical Activity in Cardiac Rehabilitation Enrollees Using Mobile Health Technologies. Circ Cardiovasc Qual Outcomes. 2022 Jul;15(7):e009182. doi: 10.1161/CIRCOUTCOMES.122.009182. Epub 2022 May 13.
PubMed 35559648Jeganathan VS, Golbus JR, Gupta K, Luff E, Dempsey W, Boyden T, Rubenfire M, Mukherjee B, Klasnja P, Kheterpal S, Nallamothu BK. Virtual AppLication-supported Environment To INcrease Exercise (VALENTINE) during cardiac rehabilitation study: Rationale and design. Am Heart J. 2022 Jun;248:53-62. doi: 10.1016/j.ahj.2022.02.012. Epub 2022 Feb 27.
PubMed 35235834
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual AppLication-supported ENvironment To INcrease Exercise During Cardiac Rehabilitation Study
- ClinicalTrials.gov ID
- NCT04587882
- Acronym / sponsor ID
- VALENTINE / HUM00162365
- Conditions
- Heart Diseases, Cardiovascular Diseases
- Keywords
- Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Corewell Health West
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 14 Oct 2020 (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.
The researchers are trying to determine whether a smartwatch and a mobile application, which together deliver activity and goal setting notifications, can increase activity levels for patients enrolled in cardiac rehabilitation.
Detailed description
The VALENTINE Cardiac Rehabilitation Study will evaluate a digital intervention to supplement cardiac rehabilitation for low- and moderate risk patients, integrating a mobile application with physiologic and contextual information from wearables to provide incremental support to patients. The study will be performed in conjunction with planned home-, hybrid-, or center-based cardiac rehabilitation at Michigan Medicine. Participants will be randomized to the control or telehealth group. Both groups will receive a smartwatch and usual care. Participants in the telehealth arm will additionally (1) have access to activity tracking and goal setting through the VALENTINE app; (2) receive micro-randomized, contextually tailored notifications, and (3) receive weekly activity summaries via email, which will also be provided to their exercise physiologist while enrolled in cardiac rehabilitation. Contextually tailored notifications will be one of two types: walking and exercise notifications. Walking notifications are designed to encourage participants to be active though at lower than their target heart rate zone. Participants will receive 1 notification per day, on average, at one of four times. Notifications will be randomized on four dimensions of context. Exercise notifications are designed to encourage participants to exercise within their target heart rate zone. Notifications will be delivered each evening at a time of the participant's choosing. Participants will have a 50% probability of receiving a notification each evening. Notifications will be randomized on two dimensions of context. Participants will be followed for 6-months. Participants in both arms will be asked to complete a 6-minute walk test at baseline, 3-months, and 6-months using their mobile phone and smartwatch. They will additionally complete general and disease-specific quality-of-life questionnaires at baseline and at 6-months.
To account for potential measurement error between devices, for primary and secondary analyses, we will perform regression analysis to jointly test the null hypothesis H0: B0(F) = B0(A) = 0 for change between baseline and 6 months where (F) and (A) refer to Fitbit and Apple watches respectively. A secondary analysis will subsequently be performed to determine whether to reject the individual null hypotheses for each of the two devices. For all statistical analyses, the level of significance will be set at p <0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized-controlled trial where the primary purpose is secondary prevention.
| Arm | Type | Receives |
|---|---|---|
| Telehealth | Experimental | Behavioral: TelehealthParticipants will be provided with a smartwatch, have access to activity tracking and goal setting through the VALENTINE app, receive micro-randomized, contextually tailored notifications, and receive weekly activity summaries via email, which will be provided to participants and to their exercise physiologist while enrolled in cardiac rehabilitation. |
| Control | Active comparator | Behavioral: ControlParticipants will continue to receive usual care and a smartwatch but without access to the micro-randomized notifications or weekly activity summaries. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2013. Spectrum Health patients may participate if they have a Michigan Medicine MRN and data is available through connected electronic health records.
- Age > 18 and < 75
- Owns an Android or iPhone with study supported operating software.
- Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications.
- Enrolled in cardiac rehabilitation within the past 8-weeks based on one of the following indications (listed below) and has completed at least 2 cardiac rehabilitation sessions (includes orientation session; to remain in the study, participants in the hybrid program must complete at least one additional exercise session for a minimum of 2 center-based rehabilitation sessions):
Key exclusion criteria (12 listed)
- Orthopedic or neurological condition limiting ability to actively engage in exercise training session
- Greater than mild cognitive impairment
- Wrist too large to wear a smartwatch comfortably. This will be assessed by asking participants "If they have ever had difficulty wearing a watch in the past due to the band being too small."
- Currently receiving palliative care and/or in hospice care
- Severe valvular stenosis or regurgitation
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 |
|---|---|---|
| TelehealthParticipants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors. | Behavioural | Telehealth |
| ControlParticipants will get usual care and wear a smartwatch. | Behavioural | Control |
Primary outcome
Change in 6-minute walk distance
Time frame: Baseline, 6-months
6-minute walk distance is determined by the 6-minute walk test recorded using a mobile phone paired with a smartwach and recorded in meters.
1 secondary outcome
Change in average step count
Time frame: Baseline, 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 42580690Atluri N, Gupta K, Basu T, Luff E, Shi J, Boyden T, Mukherjee B, Kheterpal S, Klasnja P, Dempsey W, Nallamothu BK, Golbus JR. Characteristics of Tailored Text Messages Associated With Increased Physical Activity Among Cardiac Rehabilitation Enrollees: Secondary Analysis of a Microrandomized Trial. JMIR Mhealth Uhealth. 2026 Aug 11;14:e79792. doi: 10.2196/79792.
- Derived from this study: PubMed 38887953Golbus JR, Shi J, Gupta K, Stevens R, Jeganathan VSE, Luff E, Boyden T, Mukherjee B, Kohnstamm S, Taralunga V, Kheterpal V, Kheterpal S, Resnicow K, Murphy S, Dempsey W, Klasnja P, Nallamothu BK. Text Messages to Promote Physical Activity in Patients With Cardiovascular Disease: A Micro-Randomized Trial of a Just-In-Time Adaptive Intervention. Circ Cardiovasc Qual Outcomes. 2024 Jul;17(7):e010731. doi: 10.1161/CIRCOUTCOMES.123.010731. Epub 2024 Jun 18.
- Derived from this study: PubMed 38226512Atluri N, Mishra SR, Anderson T, Stevens R, Edwards A, Luff E, Nallamothu BK, Golbus JR. Acceptability of a Text Message-Based Mobile Health Intervention to Promote Physical Activity in Cardiac Rehabilitation Enrollees: A Qualitative Substudy of Participant Perspectives. J Am Heart Assoc. 2024 Jan 16;13(2):e030807. doi: 10.1161/JAHA.123.030807. Epub 2024 Jan 16.
- Derived from this study: PubMed 35559648Golbus JR, Gupta K, Stevens R, Jeganathan VS, Luff E, Boyden T, Mukherjee B, Klasnja P, Kheterpal S, Kohnstamm S, Nallamothu BK. Understanding Baseline Physical Activity in Cardiac Rehabilitation Enrollees Using Mobile Health Technologies. Circ Cardiovasc Qual Outcomes. 2022 Jul;15(7):e009182. doi: 10.1161/CIRCOUTCOMES.122.009182. Epub 2022 May 13.
- Derived from this study: PubMed 35235834Jeganathan VS, Golbus JR, Gupta K, Luff E, Dempsey W, Boyden T, Rubenfire M, Mukherjee B, Klasnja P, Kheterpal S, Nallamothu BK. Virtual AppLication-supported Environment To INcrease Exercise (VALENTINE) during cardiac rehabilitation study: Rationale and design. Am Heart J. 2022 Jun;248:53-62. doi: 10.1016/j.ahj.2022.02.012. Epub 2022 Feb 27.
- Individual participant dataSharing planned: No
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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.
Brahmajee K Nallamothu principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth in people with Heart Diseases and Cardiovascular Diseases, run by University of Michigan at 2 sites 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk distance (time frame: Baseline, 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587882, which also lists 5 linked publications.
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 23 Nov 2022.