Virtual AppLication-supported ENvironment To INcrease Exercise During Cardiac Rehabilitation Study

NCT04587882 | Completed

• 1 other identifier: HUM00162365
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Diseases; Cardiovascular Diseases

Keywords

Cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6-months

Secondary Outcomes (1)

• Change in average step count

  Baseline, 6-months

Other Outcomes (10)

• Proximal outcome for activity notifications.

  1-hour after an activity notification, up to 6-months.

• Proximal outcome for exercise notifications.

  The day after an exercise notification, up to 6-months.

• All-cause mortality and Cardiovascular mortality

  6-months

Study Arms (2)

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.

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.

Behavioral: Control

Interventions

Telehealth BEHAVIORAL

Participants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors.

Telehealth

Control BEHAVIORAL

Participants will get usual care and wear a smartwatch.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Corewell Health West: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49525, United States

Location

Related Publications (4)

• Golbus 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.

  PMID: 38887953 DERIVED

• Atluri 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.

  PMID: 38226512 DERIVED

• Golbus 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.

  PMID: 35559648 DERIVED

• Jeganathan 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.

  PMID: 35235834 DERIVED

MeSH Terms

Conditions

Heart Diseases; Cardiovascular Diseases

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Brahmajee K Nallamothu

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: A prospective, randomized-controlled trial where the primary purpose is secondary prevention.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: October 23, 2020
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)