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NCT03907891 · ClinicalTrials.gov registry record · NA
Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 224
- Enrollment target
NCT03907891: Completed NA study, sponsored by University of Illinois at Chicago.
NCT03907891 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 224 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03907891, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 224 participants
- Enrollment target
Study 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 mo
Primary Outcome
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.
Interventions
- BEHAVIORAL Attention control
- BEHAVIORAL Motivational social support from nurse
- BEHAVIORAL Motivational social support from nurse with additional support from significant other
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2024-09-16 |
| Phase | NA |
What the finished NCT03907891 record still lists
NCT03907891 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Attention control is the first listed.
NCT03907891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03907891 about?
NCT03907891 is a clinical study titled "Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations". 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...
What is the current status of trial NCT03907891?
This trial is currently completed. It is a NA study. The enrollment target is 224 participants. The study started on 2019-08-01. Estimated completion is 2024-09-16.
What interventions are being tested in trial NCT03907891?
The interventions under investigation include: Attention control (BEHAVIORAL), Motivational social support from nurse (BEHAVIORAL), Motivational social support from nurse with additional support from significant other (BEHAVIORAL).
Who is sponsoring clinical trial NCT03907891?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03907891's enrollment target sits among peer trials
224 478th of 2000 higher than 1,520 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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