Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03907891
Acronym
Heart Up!
Enrollment
224
Registered
2019-04-09
Start date
2019-08-01
Completion date
2024-09-16
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Hopelessness, Ischemic Heart Disease, Motivation, Physical Activity, Social Support

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.

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.

Interventions

BEHAVIORALMotivational social support from nurse

A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages.

BEHAVIORALMotivational 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.

BEHAVIORALAttention control

A 60-minute session with a nurse focused on American Heart Association educational videos and written information.

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

The data collectors are also masked in the clinical trial.

Intervention model description

A three group RCT will be used to test the effectiveness of a mHealth intervention (Heart Up!) versus attention control to promote increased physical activity and reduce state hopelessness. Patients will be randomized 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, and 2, 6, 9 and 12 months.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Minutes/Day of Physical Activity (Measured by Actigraph)Month 6Minutes/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.
State Hopelessness (Measured by State-Trait Hopelessness Scale)Month 6Participant'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.

Secondary

MeasureTime frameDescription
Exercise Self-Regulation QuestionnaireMonth 6Participant'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.
ENRICHD Social Support InventoryMonth 6Participant'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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSusan L Dunn, PhD

University of Illinois at Chicago

Participant flow

Recruitment details

A total of 224 participants were enrolled while hospitalized for an IHD event in one large hospital in the Midwestern United States from August 2019 to November 2023. Participants were randomized to 1 of 3 groups: 1) Motivational social support (MSS) from a nurse, 2) MSS from a nurse with significant other support (SOS), and 3) attention control. Each SOS group participant identified a significant other who was asked to send the participant text messages.

Pre-assignment details

Significant others were considered enrolled in the study only for the purposes of sending text messages to the MSS with SOS group participants. No data were collected from the significant others. Numbers provided for study enrollment, start, and completion represent the number of individual participants in the MI group, number of individual participants in the AC group, and the number of dyads in the MI with SOS group.

Baseline characteristics

Characteristic
Age, Continuous62.0 years
STANDARD_DEVIATION 9.4
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
217 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
202 Participants
Sex: Female, Male
Female
68 Participants
Sex: Female, Male
Male
50 Participants
State Hopelessness Baseline (2 Weeks: pre-intervention)1.813 units on a scale
STANDARD_DEVIATION 0.372
State Hopelessness Screening and Enrollment2.07 units on a scale
STANDARD_DEVIATION 0.26

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
1 / 750 / 750 / 74
other
Total, other adverse events
25 / 7527 / 7523 / 74
serious
Total, serious adverse events
5 / 757 / 752 / 74

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026