Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations
Heart Up!
A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease
3 other identifiers
interventional
224
1 country
1
Brief Summary
After a 30-year decline, heart disease is projected to increase up to 18% by 2030. Participation rates in cardiac rehabilitation remain extremely low and hopeless individuals are less likely to participate. This innovative study has the potential to advance science, improve patient care, and improve patient outcomes by demonstrating the effectiveness of the Heart Up! program to increase physical activity and reduce hopelessness in patients with heart disease. Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. A total of 225 hopeless IHD patients will be enrolled from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). It is hypothesized that 1) The MSS with SOS group will have the greatest increase in average minutes of moderate to vigorous PA per day at 8 and 24 weeks as compared to the MSS only or AC groups; 2) Greater increase in minutes of moderate to vigorous PA per day will be associated with decreased state hopelessness levels from baseline to weeks 8 and 24; and 3) Increased social support and increased motivation will mediate the effects of Heart Up! on a greater increase in moderate to vigorous PA at 8 and 24 weeks. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2024
CompletedResults Posted
Study results publicly available
February 13, 2026
CompletedFebruary 13, 2026
January 1, 2026
5.1 years
April 3, 2019
December 27, 2025
January 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Minutes/Day of Physical Activity (Measured by Actigraph)
Minutes/day of moderate to vigorous physical activity as measured by an ActiGraph GT9X Link Accelerometer. Higher number of minutes/day represents a better outcome, lower number of minutes/day represents a worse outcome. Characteristics were not collected for significant others in the SOS group.
Month 6
State Hopelessness (Measured by State-Trait Hopelessness Scale)
Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse). Characteristics were not collected for significant others in the SOS group.
Month 6
Secondary Outcomes (2)
Exercise Self-Regulation Questionnaire
Month 6
ENRICHD Social Support Inventory
Month 6
Study Arms (3)
Motivational social support (MSS) from a nurse alone
EXPERIMENTALParticipants will receive a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse. The nurse will apply motivational interviewing techniques to explore the patient's thoughts about making a behavior change to attain adequate physical activity (PA). Patients will be encouraged to exercise based on instructions provided by the hospital staff. The patient's ability to take their radial pulse before and after PA will be assessed, and patients will be provided written instructions on the correct manner to take a radial pulse. Patients will receive daily motivational text messages from the nurse for 6 weeks. The texts will be sent via the REDCap automated system. The automated system confirms that texts were sent. The motivational interviewer nurse will confirm by phone that the patient receives her/his first text from the REDCap system.
MSS from nurse with additional significant other support (SOS)
EXPERIMENTALParticipants will also receive a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse and text messages from a nurse for 6 weeks, as described in arm 1. In addition, patients will receive daily text messages from their significant other for 6 weeks. Researchers developed the 42 significant other text messages. The motivational interviewing nurse will provide the text messages to the significant other in writing. The order of texts sent from the significant other will be randomized so that we can determine their effectiveness in general. The significant other will be asked to type and send the text message listed for each date to the patient. Study staff will confirm by phone that the patient received the first text from the significant other. Patients will be asked to track the number of text messages from the significant other that they read over the 6-week period using the log provided.
Attention control (AC)
ACTIVE COMPARATORParticipants in the AC group will receive a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) viewing of American Heart Association educational videos and and documents regarding IHD. The nurse will additionally provide a written copy of the hospital physical activity instructions, will assess the patient's ability to take their pulse, and provide written instructions on the correct manner to take a radial pulse.
Interventions
A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages.
A 60-minute session with a nurse focused on American Heart Association educational videos and written information.
A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages from both a nurse and the patient's self-identified significant other.
Eligibility Criteria
You may qualify if:
- Adults ≥18 years old
- Diagnosed with MI, unstable angina, who undergo percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery
- Use a cell phone with text messaging
- Receive a recommendation to engage in physical activity either at home or in a hospital-based cardiac rehabilitation setting
- Have a planned discharge home
- Can identify a significant other who can text message them
- Speak and read English
- Can complete the screening instrument
- A score of ≥1.8 on the 10-item state subscale of the State-Trait Hopelessness Scale
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Related Publications (5)
Dunn SL, DeVon HA, Collins EG, Luong A, Buursma MP, Gutierrez-Kapheim M, Bronas UG. Suicide Risk Management Protocol for a Randomized Controlled Trial of Cardiac Patients Reporting Hopelessness. Nurs Res. 2021 Jan/Feb;70(1):72-79. doi: 10.1097/NNR.0000000000000474.
PMID: 32956255BACKGROUNDDunn SL, Robbins LB, Tintle NL, Collins EG, Bronas UG, Goodyke MP, Luong A, Gutierrez-Kapheim M, DeVon HA. Heart up! RCT protocol to increase physical activity in cardiac patients who report hopelessness: Amended for the COVID-19 pandemic. Res Nurs Health. 2021 Apr;44(2):279-294. doi: 10.1002/nur.22106. Epub 2021 Jan 11.
PMID: 33428224BACKGROUNDLuong A, Goodyke M, Dunn SL, Baynard T, Bronas U. ActiGraph and Short-term Heart Rate Variability Study Protocol: Amended for the COVID-19 Pandemic. J Cardiovasc Nurs. 2021 Nov-Dec 01;36(6):599-608. doi: 10.1097/JCN.0000000000000817.
PMID: 33833190BACKGROUNDGoodyke MP, Tintle N, Collins E, DeVon HA, Bronas UG, Baynard T, Dunn SL. Lower Perceived Social Support Associated With Greater Hopelessness in Patients After an Acute Ischemic Heart Disease Event. J Cardiovasc Nurs. 2025 Sep-Oct 01;40(5):E239-E247. doi: 10.1097/JCN.0000000000001163. Epub 2024 Oct 24.
PMID: 39454079DERIVEDGoodyke MP, Bronas UG, Baynard T, Tintle N, DeVon HA, Collins E, Dunn SL. Relationships Among Heart Rate Variability, Perceived Social Support, and Hopelessness in Adults With Ischemic Heart Disease. J Am Heart Assoc. 2024 Feb 20;13(4):e032759. doi: 10.1161/JAHA.123.032759. Epub 2024 Feb 13.
PMID: 38348815DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Of the 224 patient participants enrolled during hospitalization, 66 (29.5%) reconsidered study participation prior to the post-hospital discharge data collection time point (2 weeks). Future research focused on this population should consider expanding the recruitment timeline to reduce attrition between enrollment and first data collection visit.
Results Point of Contact
- Title
- Dr. Susan Dunn, Professor Emeritus
- Organization
- University of Illinois Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Susan L Dunn, PhD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The data collectors are also masked in the clinical trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 9, 2019
Study Start
August 1, 2019
Primary Completion
September 16, 2024
Study Completion
September 16, 2024
Last Updated
February 13, 2026
Results First Posted
February 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Summary results information from the clinical trial will be submitted to ClinicalTrials.gov no later than 12 months after the trial's completion date.
- Access Criteria
- Data will only be made available under terms and conditions consistent with the informed consent provided by the individual participants, and as approved by the UIC IRB and any local, state, and federal laws and regulations. Requests can be made directly to the PI, who will review requests.
Researchers will adhere to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. Data sets and associated documentation will be provided. The data sets will include data from questionnaires, the motivational intervention, and accelerometer-measured physical activity raw data elements and summary information. The dataset will be prepared in accordance with guidelines for the data repository. Key study documents (e.g., protocols, procedures, and instruments) that will enable the use of prepared data sets by outside investigators will be provided. A summary documentation file will be created to provide a complete overview of the data and a description of their use for investigators who are not familiar with the data set.