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

N/A

Waitlist Available

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

No Placebo-Only Group

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ActiGraph GT9X Link Accelerometer

State-Trait Hopelessness Scale

Secondary study objectives

ENRICHD Social Support Inventory

Exercise Self-Regulation Questionnaire

Other study objectives

Cardiac rehabilitation

Charlson Comorbidity Index

Coronavirus Impact Scale

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Motivational social support from nurse with additional support from significant other

2019

N/A

~230

Motivational social support from nurse

2019

N/A

~230