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Motivational Support for Physical Activity in Heart Disease (Heart Up! Trial)

N/A
Recruiting
Led By Susan L Dunn, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a planned discharge home
Diagnosed with MI, unstable angina, who undergo percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights

Heart Up! Trial Summary

This trial is testing whether a new program called "Heart Up!" can help people with heart disease who feel hopeless. The program uses text messages to motivate patients to be more physically active. The goal is to see if this increases physical activity and reduces hopelessness.

Who is the study for?
Adults over 18 with heart disease, specifically those who've had a myocardial infarction or unstable angina and undergone certain heart procedures. Participants must use text messaging on a cell phone, be recommended for physical activity post-discharge, speak English, and score ≥1.8 on the Hopelessness Scale.Check my eligibility
What is being tested?
The 'Heart Up!' program aims to increase physical activity and reduce hopelessness in patients with ischemic heart disease. It's tested through three groups: one receiving motivational support from nurses, another adding support from a significant other, and an attention control group.See study design
What are the potential side effects?
Since this trial focuses on motivational social support rather than medication or invasive therapy, traditional side effects are not expected. However, participants may experience emotional or psychological responses to increased physical activity or social interactions.

Heart Up! Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled to be discharged home after treatment.
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I have had a heart attack or unstable chest pain and underwent a procedure to improve blood flow to my heart.

Heart Up! Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ActiGraph GT9X Link Accelerometer
State-Trait Hopelessness Scale
Secondary outcome measures
ENRICHD Social Support Inventory
Exercise Self-Regulation Questionnaire
Other outcome measures
Cardiac rehabilitation
Charlson Comorbidity Index
Coronavirus Impact Scale
+5 more

Heart Up! Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Motivational social support (MSS) from a nurse aloneExperimental Treatment1 Intervention
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.
Group II: MSS from nurse with additional significant other support (SOS)Experimental Treatment1 Intervention
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.
Group III: Attention control (AC)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
608 Previous Clinical Trials
1,559,024 Total Patients Enrolled
27 Trials studying Depression
7,031 Patients Enrolled for Depression
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,336 Total Patients Enrolled
24 Trials studying Depression
5,347 Patients Enrolled for Depression
Susan L Dunn, PhDPrincipal Investigator - University of Illinois at Chicago
Edward Hospital
Medical School - Creighton University
Advocate Illinois Masonic Medical Center, Residency in Obstetrics and Gynecology

Media Library

Attention control Clinical Trial Eligibility Overview. Trial Name: NCT03907891 — N/A
Depression Research Study Groups: MSS from nurse with additional significant other support (SOS), Motivational social support (MSS) from a nurse alone, Attention control (AC)
Depression Clinical Trial 2023: Attention control Highlights & Side Effects. Trial Name: NCT03907891 — N/A
Attention control 2023 Treatment Timeline for Medical Study. Trial Name: NCT03907891 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current vacancies for participation in this medical trial?

"Based on the clinicaltrials.gov report, this inquiry is now recruiting patients. It was posted in August of 2019 and most recently updated in October 2020."

Answered by AI

What is the highest amount of participants that are being accepted for this experiment?

"Correct. According to information available on clinicaltrials.gov, this medical study is still recruiting patients and was first published on August 1st 2019. It has been updated most recently on October 13th 2022 and requires 225 participants from one site."

Answered by AI
~0 spots leftby May 2024