NCT04314583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

2.5 years

First QC Date

March 13, 2020

Last Update Submit

April 3, 2023

Conditions

Keywords

depressionpessimismgratitudenursing

Outcome Measures

Primary Outcomes (1)

  • Percent Completion of Cardiac Rehabilitation Program

    Percentage of patients in each arm who complete the cardiac rehabilitation program.

    12 weeks

Secondary Outcomes (5)

  • Change in Gratitude

    12 weeks

  • Change in Dispositional Optimism

    12 weeks

  • Change in Resilience

    12 weeks

  • Hospital Readmission

    one year

  • Mortality

    one year

Study Arms (2)

Attention Control Group

ACTIVE COMPARATOR

Adult patients attending cardiovascular rehabilitation.

Behavioral: Attention Control

Gratitude Journaling Group

EXPERIMENTAL

Adult patients attending cardiovascular rehabilitation.

Behavioral: Gratitude Journaling

Interventions

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.

Attention Control Group

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.

Gratitude Journaling Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Martha Biddle, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 19, 2020

Study Start

September 1, 2020

Primary Completion

March 17, 2023

Study Completion

March 17, 2023

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations