Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations (Heart Up!)
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|ClinicalTrials.gov Identifier: NCT03907891|
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : October 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease Hopelessness Physical Activity Motivation Social Support Covid19||Behavioral: Motivational social support from nurse Behavioral: Motivational social support from nurse with additional support from significant other Behavioral: Attention control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|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, and 2, 6, 9 and 12 months.|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The data collectors are also masked in the clinical trial.|
|Official Title:||A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: Motivational social support (MSS) from a nurse alone
Participants will receive a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) 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)
Participants will also receive a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) 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)
Participants in the AC group will receive a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) 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.
- ActiGraph GT9X Link Accelerometer [ Time Frame: Month 12 ]Mean minutes/day moderate to vigorous physical activity
- State-Trait Hopelessness Scale [ Time Frame: Month 12 ]Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse).
- Exercise Self-Regulation Questionnaire [ Time Frame: Month 12 ]Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better).
- ENRICHD Social Support Inventory [ Time Frame: Month 12 ]Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better).
- Charlson Comorbidity Index [ Time Frame: Week 1 ]Comorbidity score based on medical record abstraction. Total score range= 0 (better) to 100 (worse).
- Cardiac Rehabilitation Exercise Participation Tool [ Time Frame: Month 12 ]Participant's report of participation level with exercise in home, community or cardiac rehabilitation program
- Patient Health Questionnaire-9 [ Time Frame: Month 12 ]Participant's report of mean level of depressive symptoms. Total score range= 0 (better) to 27 (worse).
- PROMIS-29 [ Time Frame: Month 12 ]Participant's report of mean level of well-being. Total score range= 4 (better) to 20 (worse).
- Snyder State Trait Scales [ Time Frame: Month 12 ]Participant's report of mean level state and trait hope. Total score range= 8 (worse) to 64 (better).
- EuroQol (EQ-5d-5L) [ Time Frame: Month 12 ]Participant's report of mean level of quality of life. Total score range= 1 (better) to 5 (worse).
- Multi-Ethnic Study of Atherosclerosis (MESA) COVID-19 Questionnaire [ Time Frame: Month 12 ]Participant's report of COVID-19 symptoms, diagnosis, testing, and social distancing. No score range (14 items).
- Coronavirus Impact Scale [ Time Frame: Month 12 ]Participant's report of impact on routine; income/ employment; access to food, medical and mental health care, extended family; and stress. No range (12 items)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Contact: Susan L Dunn, PhDfirstname.lastname@example.org|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Ashley Perkins, MSN Ashley.Perkins@spectrumhealth.org|
|Contact: Stacie Vanoosterhout, MS email@example.com|
|Principal Investigator:||Susan L Dunn, PhD||University of Illinois at Chicago|
|Responsible Party:||Susan L Dunn, PhD, RN, FAHA, FAAN, Associate Professor, University of Illinois at Chicago|
|Other Study ID Numbers:||
R01NR017649 ( U.S. NIH Grant/Contract )
3R01NR017649-04S1 ( U.S. NIH Grant/Contract )
|First Posted:||April 9, 2019 Key Record Dates|
|Last Update Posted:||October 14, 2022|
|Last Verified:||October 2022|
|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.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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