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Behavioral Intervention

Telehealth for Heart Disease (VALENTINE Trial)

N/A
Waitlist Available
Led By Brahmajee K Nallamothu
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-hour after an activity notification, up to 6-months.
Awards & highlights

VALENTINE Trial Summary

This trial is testing whether a smartwatch and app that deliver notifications can help increase activity levels for patients in cardiac rehab.

Eligible Conditions
  • Heart Disease
  • Cardiovascular Disease

VALENTINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-hour after an activity notification, up to 6-months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-hour after an activity notification, up to 6-months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in average step count
Other outcome measures
All-cause mortality and Cardiovascular mortality
Cardiovascular hospitalizations
Change in 6-minute walk distance
+5 more

VALENTINE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TelehealthExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Participants will continue to receive usual care and a smartwatch but without access to the micro-randomized notifications or weekly activity summaries.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telehealth
2013
N/A
~42390

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,759 Total Patients Enrolled
Spectrum Health HospitalsOTHER
64 Previous Clinical Trials
552,986 Total Patients Enrolled
Brahmajee K Nallamothu5.01 ReviewsPrincipal Investigator - University of Michigan
University of Michigan
5Patient Review
Dr. Nallamothu's bedside manner is excellent. He and his team are very considerate of their patients' needs and make sure to communicate effectively about health conditions, recommended medications, and clinical procedures. I felt very reassured by Dr. Nallamothu's skills as an interventionist and he did a great job of explaining the procedures he was undertaking and his findings. His staff are also excellent communicators and very patient-centered. I would highly recommend him.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Heart JournalJournal
Virtual Application-supported Environment to Increase Exercise (VALENTINE) During Cardiac Rehabilitation Study: Rationale and Design
Jeganathan, V. Swetha, Jessica R. Golbus, Kashvi Gupta, Evan Luff, Walter Dempsey, Thomas Boyden, Melvyn Rubenfire, et al.. 2022. “Virtual Application-supported Environment to Increase Exercise (VALENTINE) During Cardiac Rehabilitation Study: Rationale and Design”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2022.02.012.
Circulation: Cardiovascular Quality and OutcomesJournal
Understanding Baseline Physical Activity in Cardiac Rehabilitation Enrollees Using Mobile Health Technologies
Golbus, Jessica R., Kashvi Gupta, Rachel Stevens, V. Swetha Jeganathan, Evan Luff, Thomas Boyden, Bhramar Mukherjee, et al.. 2022. “Understanding Baseline Physical Activity in Cardiac Rehabilitation Enrollees Using Mobile Health Technologies”. Circulation: Cardiovascular Quality and Outcomes. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circoutcomes.122.009182.
American Heart JournalJournal
Virtual Application-supported Environment to Increase Exercise (VALENTINE) During Cardiac Rehabilitation Study: Rationale and Design
Jeganathan, V. Swetha, Jessica R. Golbus, Kashvi Gupta, Evan Luff, Walter Dempsey, Thomas Boyden, Melvyn Rubenfire, et al.. 2022. “Virtual Application-supported Environment to Increase Exercise (VALENTINE) During Cardiac Rehabilitation Study: Rationale and Design”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2022.02.012.
Circulation: Cardiovascular Quality and OutcomesJournal
Understanding Baseline Physical Activity in Cardiac Rehabilitation Enrollees Using Mobile Health Technologies
Golbus, Jessica R., Kashvi Gupta, Rachel Stevens, V. Swetha Jeganathan, Evan Luff, Thomas Boyden, Bhramar Mukherjee, et al.. 2022. “Understanding Baseline Physical Activity in Cardiac Rehabilitation Enrollees Using Mobile Health Technologies”. Circulation: Cardiovascular Quality and Outcomes. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circoutcomes.122.009182.
~50 spots leftby Apr 2025
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