Covid19, Hopelessness, Ischemic Heart Disease, Motivation, Physical Activity, Social Support
Conditions
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
A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages.
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.
A 60-minute session with a nurse focused on American Heart Association educational videos and written information.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Minutes/Day of Physical Activity (Measured by Actigraph) | 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. |
| State Hopelessness (Measured by State-Trait Hopelessness Scale) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Self-Regulation Questionnaire | 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. |
| ENRICHD Social Support Inventory | 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. |
Countries
United States
Contacts
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, Continuous | 62.0 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 Enrollment | 2.07 units on a scale STANDARD_DEVIATION 0.26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 75 | 0 / 75 | 0 / 74 |
| other Total, other adverse events | 25 / 75 | 27 / 75 | 23 / 74 |
| serious Total, serious adverse events | 5 / 75 | 7 / 75 | 2 / 74 |