Clinical trial NCT03907891: Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations
Official title: A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Hopelessness
Physical Activity
Motivation
Social Support
Covid19
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-04-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ActiGraph GT9X Link Accelerometer
timeFrame: Month 12
measure: State-Trait Hopelessness Scale
timeFrame: Month 12
Secondary outcomes:
measure: Exercise Self-Regulation Questionnaire
timeFrame: Month 12
measure: ENRICHD Social Support Inventory
timeFrame: Month 12
Other outcomes:
measure: Charlson Comorbidity Index
timeFrame: Week 1
measure: Cardiac Rehabilitation Exercise Participation Tool
timeFrame: Month 12
measure: Patient Health Questionnaire-9
timeFrame: Month 12
measure: PROMIS-29
timeFrame: Month 12
measure: Snyder State Trait Scales
timeFrame: Month 12
measure: EuroQol (EQ-5d-5L)
timeFrame: Month 12
measure: Multi-Ethnic Study of Atherosclerosis (MESA) COVID-19 Questionnaire
timeFrame: Month 12
measure: Coronavirus Impact Scale
timeFrame: Month 12
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: University of Illinois at Chicago
name: Susan L Dunn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dunn 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.
citation: Luong 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.