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

Covid19 Clinical Trial

— Heart Up!  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03907891
• Other study ID #: 2018-1485
• Secondary ID: R01NR0176493R01N
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• COVID-19
• Covid19
• Heart Diseases
• Hopelessness
• Ischemic Heart Disease
• Motivation
• Myocardial Ischemia
• Physical Activity
• Social Support

Intervention

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

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Charlson Comorbidity Index	Comorbidity score based on medical record abstraction. Total score range= 0 (better) to 100 (worse).	Week 1
Other	Cardiac Rehabilitation Exercise Participation Tool	Participant's report of participation level with exercise in home, community or cardiac rehabilitation program	Month 12
Other	Patient Health Questionnaire-9	Participant's report of mean level of depressive symptoms. Total score range= 0 (better) to 27 (worse).	Month 12
Other	PROMIS-29	Participant's report of mean level of well-being. Total score range= 4 (better) to 20 (worse).	Month 12
Other	Snyder State Trait Scales	Participant's report of mean level state and trait hope. Total score range= 8 (worse) to 64 (better).	Month 12
Other	EuroQol (EQ-5d-5L)	Participant's report of mean level of quality of life. Total score range= 1 (better) to 5 (worse).	Month 12
Other	Multi-Ethnic Study of Atherosclerosis (MESA) COVID-19 Questionnaire	Participant's report of COVID-19 symptoms, diagnosis, testing, and social distancing. No score range (14 items).	Month 12
Other	Coronavirus Impact Scale	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
Primary	ActiGraph GT9X Link Accelerometer	Mean minutes/day moderate to vigorous physical activity	Month 12
Primary	State-Trait Hopelessness Scale	Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse).	Month 12
Secondary	Exercise Self-Regulation Questionnaire	Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better).	Month 12
Secondary	ENRICHD Social Support Inventory	Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better).	Month 12