Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03907891
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2019-04-03
Brief Title:
Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease With COVID-19 Considerations
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Heart Up
Brief 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 34 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
Detailed Description:
Hopelessness is associated with a 34 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 Cohens Stress and Coping Social Support Theory has shown feasibility and preliminary efficacy for a motivational intervention that integrates social support from both the patients 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-placephysical 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 NINRs investment in self-management to improve the quality of life for individuals with chronic illness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01NR017649-04S1 | NIH | None | httpsreporternihgovquickSearch3R01NR017649-04S1 |
| R01NR017649 | NIH | None | None |