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Gratitude Intervention for Cardiac Rehabilitation Patients

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ClinicalTrials.gov Identifier: NCT04314583
Recruitment Status : Not yet recruiting
First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Gretchen Wells, University of Kentucky

Brief Summary:
This is a single-center cohort study of patients in a cardiac rehabilitation program with a diagnosis of cardiovascular disease (CVD), including heart failure, coronary artery disease, post myocardial infarction, post percutaneous coronary intervention and post cardiac surgery. Participants will be randomized to the gratitude intervention or an attention control group. This study is a pilot study to determine the feasibility and acceptability of administering the gratitude intervention in a cardiac rehabilitation setting.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Attention Control Behavioral: Gratitude Journaling Not Applicable

Detailed Description:

Nursing-led interventions of chronic diseases, including cardiovascular disease (CVD), have been proved to be successful. Appropriately trained nurses produce high-quality care and good health outcomes for patients equivalent to that achieved by physicians with higher levels of patient satisfaction. CVD, including coronary artery disease and heart failure, is a major and rapidly growing public health problem. Despite advances in its treatment, it remains the leading cause of death in the U.S. Furthermore, the prevalence of CVD in adults is estimated to continue to rise and that by 2035, 45.1% of the U.S. population will have some form of CVD with total costs expected to reach $1.1 trillion with direct medical costs projects to reach $748.7 billion. Therefore, novel preventive efforts are needed.

Negative psychological states, including depression and pessimism (negative future expectation), have been linked with poor CVD outcomes. Despite the fact that optimism (positive future expectation) and other positive affective states have been associated with superior cardiovascular outcomes, little research has focused on interventions designed to increase positive psychological states in patients at risk for CVD. In the current trial, patients in an academic medical center cardiac rehabilitation program will be approached. Cardiac rehabilitation is an integral component in the treatment of patients with cardiovascular disease including coronary artery disease, heart failure with reduced ejection fraction, following heart valve surgery or cardiac transplantation.

One of its core components is psychological support and management. In this nursing-led study, participants will be randomized to a gratitude intervention or an attention control group. The gratitude intervention, which encourages participants to notice and appreciate the positive features of life, is based on the work of Emmons and McCullough, and involves participants writing (or if unable to write, speaking) things for which they are grateful. Much of the existing research on gratitude (noticing and appreciating the positive features of life) has focused primarily on outcomes associated with psychological factors and social interactions.

The primary aim of this feasibility study will be to determine if a gratitude intervention is acceptable and feasible in a cohort of patients attending cardiac rehabilitation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Gratitude Intervention for Cardiac Rehabilitation Patients: A Nursing-based Intervention
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Attention Control Group
Adult patients attending cardiovascular rehabilitation.
Behavioral: Attention Control
Participants in this group will be asked to recall 3 to 5 events from the prior day of the intervention and write, or if unable to write, speak about these events.

Experimental: Gratitude Journaling Group
Adult patients attending cardiovascular rehabilitation.
Behavioral: Gratitude Journaling
The gratitude journaling intervention involves participants writing or speaking 3-5 things for which they are grateful and focusing on these attributes. Participants will do this weekly for 12 weeks.




Primary Outcome Measures :
  1. Percent Completion of Cardiac Rehabilitation Program [ Time Frame: 12 weeks ]
    Percentage of patients in each arm who complete the cardiac rehabilitation program.


Secondary Outcome Measures :
  1. Change in Gratitude [ Time Frame: 12 weeks ]
    The Gratitude Questionaire (GQ6) will be used to assess gratitude at baseline and following the intervention. The GQ6 is a 6 item questionnaire with scales ranging from 1-7. Cumulative scores range from 6-42; higher scores indicate increased gratitude.

  2. Change in Dispositional Optimism [ Time Frame: 12 weeks ]
    The Life Orientation Test-Revised (LOT-R) will be used to assess optimism at baseline and following the intervention. The LOT-R is a 10-item survey, with scales ranging from 1-5. (Not all questions are scored). Cumulative scores range from 6-30; higher scores indicate increased optimism.

  3. Change in Resilience [ Time Frame: 12 weeks ]
    The Brief Resilience Scale (BRS) will be used to measure resilience at baseline and after the intervention. The BRS is a 6 item survey, with each item scored from 1-5. Raw total scores range from 6-30; final scores will be calculated as the mean of all scores. Higher scores indicate increased resiliency.

  4. Hospital Readmission [ Time Frame: one year ]
    Percent of patients readmitted to the hospital

  5. Mortality [ Time Frame: one year ]
    Percent of patients deceased



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • able to consent
  • patient at cardiac rehabilitation program at Gill Heart and Vascular Institute

Exclusion Criteria:

- under the age of 18


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): NCT04314583


Contacts
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Contact: Gretchen Wells, MD, PhD 859-323-5630 gretchen.wells@uky.edu

Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Contact: Gretchen L Wells, MD, PhD    859-323-5630    gwe233@uky.edu   
Sponsors and Collaborators
Gretchen Wells
Investigators
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Principal Investigator: Gretchen Wells, MD, PhD University of Kentucky

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Responsible Party: Gretchen Wells, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04314583    
Other Study ID Numbers: 57514
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Gretchen Wells, University of Kentucky:
depression
pessimism
gratitude
nursing
Additional relevant MeSH terms:
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Cardiovascular Diseases