Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations (Heart Up!)

January 24, 2026 updated by: Susan L Dunn, PhD, RN, FAHA, FAAN, University of Illinois at Chicago

A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Low levels of PA independently contribute to increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue to be unacceptably low in both hospital-based cardiac rehabilitation and home settings. Hopelessness frequently compounds this issue. The links among hopelessness, PA, and mortality and morbidity for patients with IHD remain unknown. 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. This research, based on Self Determination Theory and Cohen's Stress and Coping Social Support Theory, has shown feasibility and preliminary efficacy for a motivational intervention that integrates social support from both the patient's nurse and significant other to promote increased PA. 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. The study team will enroll 225 hopeless IHD patients 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). Data will be collected at baseline, months 2, 6, 9 and 12 using an accelerometer for PA and valid and reliable instruments of physical and emotional health and behaviors. The specific aims are to: 1) test the effectiveness of 6 weeks of MSS and MSS with SOS on increasing mean minutes per day of moderate to vigorous PA, measured by an ActiGraph accelerometer; 2) determine the effects of change in minutes per day of moderate to vigorous PA on state hopelessness, measured by the State-Trait Hopelessness Scale; and 3): determine if social support (measured by the ENRICHD Social Support Inventory) and motivation (measured by the Exercise Self-Regulation Questionnaire) mediate the effects of the Heart Up! intervention on PA. The specific aims of the supplement are to: 1) determine how the potentially negative impact of COVID-19 shelter-in-place/physical distancing measures on mental, social, and behavioral health outcomes are limited (moderated) by the RCT intervention and 2) using the Coronavirus Impact Scale, we will determine how the direct impact of COVID-19 life changes on mental, social, and behavioral health outcomes are limited (moderated) by the RCT intervention. 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. This proposal supports NINR's investment in self-management to improve the quality of life for individuals with chronic illness.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

• None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational social support (MSS) from a nurse alone
Participants 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.
Behavioral: Motivational social support from nurse
A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages.
Experimental: MSS from nurse with additional significant other support (SOS)
Participants 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.
Behavioral: Motivational social support from nurse with additional support from significant other
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.
Active Comparator: Attention control (AC)
Participants 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.
Behavioral: Attention control
A 60-minute session with a nurse focused on American Heart Association educational videos and written information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minutes/Day of Physical Activity (Measured by Actigraph)
Time Frame: Month 6
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)
Time Frame: Month 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Self-Regulation Questionnaire
Time Frame: Month 6
Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better). Characteristics were not collected for significant others in the SOS group.
Month 6
ENRICHD Social Support Inventory
Time Frame: Month 6
Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better). Characteristics were not collected for significant others in the SOS group.
Month 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Charlson Comorbidity Index
Time Frame: Week 1
Comorbidity score based on medical record abstraction. Total score range= 0 (better) to 100 (worse).
Week 1
Cardiac Rehabilitation Exercise Participation Tool
Time Frame: Month 12
Participant's report of participation level with exercise in home, community or cardiac rehabilitation program
Month 12
Patient Health Questionnaire-9
Time Frame: Month 12
Participant's report of mean level of depressive symptoms. Total score range= 0 (better) to 27 (worse).
Month 12
PROMIS-29
Time Frame: Month 12
Participant's report of mean level of well-being. Total score range= 4 (better) to 20 (worse).
Month 12
Snyder State Trait Scales
Time Frame: Month 12
Participant's report of mean level state and trait hope. Total score range= 8 (worse) to 64 (better).
Month 12
EuroQol (EQ-5d-5L)
Time Frame: Month 12
Participant's report of mean level of quality of life. Total score range= 1 (better) to 5 (worse).
Month 12
Multi-Ethnic Study of Atherosclerosis (MESA) COVID-19 Questionnaire
Time Frame: Month 12
Participant's report of COVID-19 symptoms, diagnosis, testing, and social distancing. No score range (14 items).
Month 12
Coronavirus Impact Scale
Time Frame: Month 12
Participant's report of impact on routine; income/ employment; access to food, medical and mental health care, extended family; and stress. No range (12 items)
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Susan L Dunn, PhD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

September 16, 2024

Study Completion (Actual)

September 16, 2024

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-1485
  • R01NR017649 (U.S. NIH Grant/Contract)
  • 3R01NR017649-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Motivational social support from nurse

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe