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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
University of Illinois at Chicago
Study ID
NCT03907891
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Motivational social support from nurse — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    A 60-minute session with a nurse focused on American Heart Association educational videos and written information.

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Jan 2026
Primary completion
Sep 16, 2024
Completion
Sep 16, 2024

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Minutes/Day of Physical Activity (Measured by Actigraph) [ Time Frame: Month 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Spectrum HealthGrand RapidsMichigan49503-

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By condition
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By specialty
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By research site
Spectrum Health· Grand Rapids, MI

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