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.
Group
Value
95% 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.
Group
Value
95% CI
Motivational Social Support (MSS) From a Nurse Alone
1.68
± 0.46
MSS From Nurse With Additional Significant Other Support (SOS)
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.
Group
Value
95% CI
Motivational Social Support (MSS) From a Nurse Alone
4.45
± 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 InventorySecondary· 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.
Group
Value
95% CI
Motivational Social Support (MSS) From a Nurse Alone
22.11
± 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)
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):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Illinois at Chicago
Last refreshed: 13 February 2026
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.