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NCT03907891: Heart Up!

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

Completed NA Results posted Last updated 13 February 2026
What this trial tests

NA trial testing Motivational social support from nurse in Ischemic Heart Disease in 224 participants. Completed in 16 September 2024.

Timeline
1 August 2019
Primary endpoint
16 September 2024
16 September 2024

Quick facts

Lead sponsorUniversity of Illinois at Chicago
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment224
Start date1 August 2019
Primary completion16 September 2024
Estimated completion16 September 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Illinois at Chicago

Who can join

18 and older, any sex, with Ischemic Heart Disease or Hopelessness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Minutes/Day of Physical Activity (Measured by Actigraph) Primary · 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.

GroupValue95% CI
Motivational Social Support (MSS) From a Nurse Alone (Individual Participants)6.7± 8.1
MSS From Nurse With Additional Significant Other Support (SOS) (Dyads)4.8± 5.4
Attention Control (AC) (Individual Participants)8.6± 12.0
State Hopelessness (Measured by State-Trait Hopelessness Scale) Primary · 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.

GroupValue95% CI
Motivational Social Support (MSS) From a Nurse Alone1.68± 0.46
MSS From Nurse With Additional Significant Other Support (SOS)1.72± 0.52
Attention Control (AC)1.74± 0.42
Exercise Self-Regulation Questionnaire Secondary · 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.

GroupValue95% CI
Motivational Social Support (MSS) From a Nurse Alone4.45± 1.09
MSS From Nurse With Additional Significant Other Support (SOS)4.82± 1.05
Attention Control (AC)4.86± 1.28
ENRICHD Social Support Inventory Secondary · 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.

GroupValue95% CI
Motivational Social Support (MSS) From a Nurse Alone22.11± 3.18
MSS From Nurse With Additional Significant Other Support (SOS)22.86± 4.48
Attention Control (AC)22.64± 2.82

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from individual patient participants from enrollment to 6 months. Data (including adverse event data) were not collected from significant others in SOS group whose role was limited to sending text messages from their phone for a 6-week period as part of the intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Motivational Social Support (MSS) From a Nurse Alone (Individual Participants)
Serious: 5/75 (7%)
Deaths: 1/75
MSS From Nurse With Additional Significant Other Support (SOS) (Dyads)
Serious: 7/75 (9%)
Deaths: 0/75
Attention Control (AC) (Individual Participants)
Serious: 2/74 (3%)
Deaths: 0/74

Serious adverse events (3 terms)

ReactionSystemMotivational Social Suppor…MSS From Nurse With Additi…Attention Control (AC) (In…
Coronary reocclusionCardiac disorders
Suicidal ideation moderateGeneral disorders
Suicidal ideation highGeneral disorders
Other adverse events (3 terms — click to expand)

ReactionSystemMotivational Social Suppor…MSS From Nurse With Additi…Attention Control (AC) (In…
Change in health all causeGeneral disorders
Hospitalization all causeGeneral disorders
Suicidal ideation lowGeneral disorders

Most-reported serious reactions: Coronary reocclusion, Suicidal ideation moderate, Suicidal ideation high.

Data from ClinicalTrials.gov NCT03907891 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Relationships Among Heart Rate Variability, Perceived Social Support, and Hopelessness in Adults With Ischemic Heart Disease.
    Goodyke MP, Bronas UG, Baynard T, Tintle N, et al · · 2024 · cited 6× · PMID 38348815 · DOI 10.1161/jaha.123.032759
  2. Suicide Risk Management Protocol for a Randomized Controlled Trial of Cardiac Patients Reporting Hopelessness.
    Dunn SL, DeVon HA, Collins EG, Luong A, et al · · 2021 · cited 5× · PMID 32956255 · DOI 10.1097/nnr.0000000000000474
  3. ActiGraph and Short-term Heart Rate Variability Study Protocol: Amended for the COVID-19 Pandemic.
    Luong A, Goodyke M, Dunn SL, Baynard T, et al · · 2021 · cited 4× · PMID 33833190 · DOI 10.1097/jcn.0000000000000817
  4. Assessment of Discriminant Validity for Measures of Hope and Hopelessness in Adults With an Acute Cardiac Event.
    DeVon HA, Tintle N, Rivera E, Davis A, et al · · 2026 · PMID 41492779 · DOI 10.1002/nur.70050

Verify or expand the search:

Other recruiting trials for Ischemic Heart Disease

Currently open trials in the same condition.

Other University of Illinois at Chicago trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03907891.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing