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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Attention Control Behavioral: Gratitude Journaling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Percent Completion of Cardiac Rehabilitation Program [ Time Frame: 12 weeks ]Percentage of patients in each arm who complete the cardiac rehabilitation program.
- 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.
- 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.
- 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.
- Hospital Readmission [ Time Frame: one year ]Percent of patients readmitted to the hospital
- Mortality [ Time Frame: one year ]Percent of patients deceased
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
|Contact: Gretchen Wells, MD, PhDemail@example.com|
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Contact: Gretchen L Wells, MD, PhD 859-323-5630 firstname.lastname@example.org|
|Principal Investigator:||Gretchen Wells, MD, PhD||University of Kentucky|