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Trial record 43 of 1556 for:    rural

Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction (eMotion)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441086
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
Sigma Theta Tau International
Information provided by (Responsible Party):
Kelly L. Wierenga, Indiana University

Brief Summary:

The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in rural US adults who have experienced a myocardial infarction and participating in phase II cardiac rehabilitation.

This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables. Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), and symptoms [depression, anxiety, pain, sleep, and fatigue]) among rural dwelling adults enrolled in cardiac rehabilitation after a first myocardial infarction.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Emotions Behavioral: eMotion Behavioral: Healthy Living Active Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eMotion
The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for aging rural adults following a first cardiac event in tandem with usual cardiac rehabilitation. The intervention helps patients recognize their emotions, balance emotional and physical wellbeing, and implement emotion regulation strategies effectively.
Behavioral: eMotion
Content is delivered within the context of emotion provoking situations common in those recovering from a first MI and in maintaining MVPA. The new on-demand access to asynchronous content sessions provides didactic presentation of video and written material based on weekly needs assessments. Weekly scheduled synchronous video chat sessions, led by a nurse interventionist, will provide further individualization and application of content materials.

Active Comparator: Healthy living active control Behavioral: Healthy Living Active Control
The attention control group will receive their usual cardiac rehabilitation and a comparable dose matched (to that of the eMotion intervention) of healthy living web content and video chat with a nurse.

No Intervention: Usual care



Primary Outcome Measures :
  1. Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: 1 week trials at baseline, 10 weeks, and 20 weeks ]
    Minutes spent in MVPA


Secondary Outcome Measures :
  1. Depression subscale from the Depression Anxiety and Stress Scale [ Time Frame: Baseline to 20 weeks ]
    Symptoms of depression

  2. Anxiety subscale from the Depression Anxiety and Stress Scale [ Time Frame: Baseline to 20 weeks ]
    Symptoms of anxiety

  3. Stress from the Perceived Stress Scale [ Time Frame: Baseline to 20 weeks ]
    Perceptions of stress



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:

  1. First time MI as documented in medical record and verified by cardiologist;
  2. enrolled in cardiac rehabilitation phase II program within past 6 weeks;
  3. living independently; and
  4. home address in rural zip code.

Exclusion Criteria:

  1. does not speak English;
  2. major Axis 1 psychiatric diagnosis (e.g. schizophrenia);
  3. terminal cancer;
  4. legally blind, and
  5. history of cardiac arrest.

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): NCT04441086


Contacts
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Contact: Kelly Wierenga, PhD 317-274-8091 kwiereng@iu.edu

Sponsors and Collaborators
Indiana University
Sigma Theta Tau International
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Responsible Party: Kelly L. Wierenga, Assistant Professor, Nursing, Indiana University
ClinicalTrials.gov Identifier: NCT04441086    
Other Study ID Numbers: 2002325890
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kelly L. Wierenga, Indiana University:
Emotion regulation
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases