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Reducing Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease (HeartUp!)

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ClinicalTrials.gov Identifier: NCT03907891
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Illinois at Chicago

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 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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Hopelessness Physical Activity Motivation Social Support Behavioral: Motivational social support from nurse Behavioral: Motivational social support from nurse with additional support from significant other Behavioral: Attention control Not Applicable

Detailed Description:
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. 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 Cohen's Stress and Coping Social Support Theory, has shown feasibility and preliminary efficacy for a motivational intervention that integrates social support from both the patient's 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, 8 and 24 weeks 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 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 NINR's investment in self-management to improve the quality of life for individuals with chronic illness.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A three group RCT will be used to test the effectiveness of a mHealth intervention (Heart Up!) versus attention control to promote increased physical activity and reduce state hopelessness. Patients will be randomized 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, 8 and 24 weeks.
Masking: Double (Care Provider, Investigator)
Masking Description: The data collectors will also be masked in the clinical trial.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motivational social support (MSS) from a nurse alone
Patients will receive a 60-minute session of motivational interviewing 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.
Behavioral: Motivational social support from nurse
A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages.

Experimental: MSS from nurse with additional significant other support (SOS)
Patients will also receive a 60-minute session of motivational interviewing 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.
Behavioral: Motivational social support from nurse with additional support from significant other
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.

Active Comparator: Attention control (AC)
Patients in the AC group will receive a 60-minutes session with a nurse focused on the 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.
Behavioral: Attention control
A 60-minute session with a nurse focused on American Heart Association educational videos and written information.




Primary Outcome Measures :
  1. ActiGraph GT9X Link Accelerometer [ Time Frame: Week 24 ]
    Mean minutes/day moderate to vigorous physical activity

  2. State-Trait Hopelessness Scale [ Time Frame: Week 24 ]
    Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse).


Secondary Outcome Measures :
  1. Exercise Self-Regulation Questionnaire [ Time Frame: Week 24 ]
    Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better).

  2. ENRICHD Social Support Inventory [ Time Frame: Weeks 24 ]
    Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better).


Other Outcome Measures:
  1. Charlson Comorbidity Index [ Time Frame: Week 1 ]
    Comorbidity score based on medical record abstraction. Total score range= 0 (better) to 100 (worse).

  2. Cardiac Rehabilitation Exercise Participation Tool [ Time Frame: Week 24 ]
    Participant's report of participation level with exercise in home, community or cardiac rehabilitation program

  3. Patient Health Questionnaire-9 [ Time Frame: Week 24 ]
    Participant's report of mean level of depressive symptoms. Total score range= 0 (better) to 27 (worse).

  4. PROMIS-29 [ Time Frame: Week 24 ]
    Participant's report of mean level of well-being. Total score range= 4 (better) to 20 (worse).

  5. Snyder State Trait Scales [ Time Frame: Week 24 ]
    Participant's report of mean level state and trait hope. Total score range= 8 (worse) to 64 (better).

  6. EuroQol (EQ-5d-5L) [ Time Frame: Week 24 ]
    Patient's report of mean level of quality of life. Total score range= 1 (better) to 5 (worse).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥18 years old
  • Diagnosed with MI, unstable angina, who undergo percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery
  • Use a cell phone with text messaging
  • Receive a recommendation to engage in physical activity either at home or in a hospital-based cardiac rehabilitation setting
  • Have a planned discharge home
  • Can identify a significant other who can text message them
  • Live within 100 miles of the hospital
  • Speak and read English
  • Can complete the screening instrument
  • A score of ≥1.8 on the 10-item state subscale of the State-Trait Hopelessness Scale

Exclusion Criteria:

• None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907891


Contacts
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Contact: Susan L Dunn, PhD 3129961367 sdunn01@uic.edu
Contact: Julie Law, BS 3124137273 julielaw@uic.edu

Locations
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United States, Michigan
Spectrum Health Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Denise K Busman, MSN       denise.busman@spectrumhealth.org   
Contact: Stacie VanOosterhout, MS       stacie.vanoosterhout@spectrumhealth.org   
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Susan L Dunn, PhD University of Illinois at Chicago

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Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03907891     History of Changes
Other Study ID Numbers: 2018-1485
R01NR017649 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Researchers will adhere to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. Data sets and associated documentation will be provided. The data sets will include data from questionnaires, the motivational intervention, and accelerometer-measured physical activity raw data elements and summary information. The dataset will be prepared in accordance with guidelines for the data repository. Key study documents (e.g., protocols, procedures, and instruments) that will enable the use of prepared data sets by outside investigators will be provided. A summary documentation file will be created to provide a complete overview of the data and a description of their use for investigators who are not familiar with the data set.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Summary results information from the clinical trial will be submitted to ClinicalTrials.gov no later than 12 months after the trial's completion date.
Access Criteria: Data will only be made available under terms and conditions consistent with the informed consent provided by the individual participants, and as approved by the UIC IRB and any local, state, and federal laws and regulations. Requests can be made directly to the PI, who will review requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases