Clinical trial NCT04314583: Gratitude Intervention for Cardiac Rehabilitation Patients
Official title: Feasibility of a Gratitude Intervention for Cardiac Rehabilitation Patients: A Nursing-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: depression
pessimism
gratitude
nursing
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent Completion of Cardiac Rehabilitation Program
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Gratitude
timeFrame: 12 weeks
measure: Change in Dispositional Optimism
timeFrame: 12 weeks
measure: Change in Resilience
timeFrame: 12 weeks
measure: Hospital Readmission
timeFrame: one year
measure: Mortality
timeFrame: one year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Martha Biddle, PhD
role: PRINCIPAL_INVESTIGATOR
References: