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Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction (GReATCARE)

Primary Purpose

Myocardial Infarction, Acute

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Gratitude list
List of any event
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myocardial Infarction, Acute focused on measuring Psychosocial intervention, positive psychology, mental health, self-care,, Myocardial infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ST-segment elevation myocardial infarction (STEMI) patients Undergoing primary percutaneous coronary intervention (pPCI). Exclusion Criteria: Patients in need of ventilatory support; Over 75 years of age; Delirium or dementia reported by the attending physician. Not able to answer the questionnaires. Very high depression scores requiring referral to psychological care services

Sites / Locations

  • Marcia Moura Schmidt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gratitude List

List of any event

Arm Description

Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for.

Participants must to write 3-5 words a day for 14 days about events of your own choosing that impressed the participant during the day, whether positive or negative.

Outcomes

Primary Outcome Measures

Changes in self-care scores
Changes in self-care scores assessed from Appraisal of Self-care Agency (ASA)
Changes in negative psychological states
Changes in DASS-21 scores

Secondary Outcome Measures

Changes in gratitude scores
Changes in Gratitude Questionnaire - GQ-6 scores
Behavioral changes (physical activity, diet...)
Changes in modifiable cardiovascular risk factors: cholesterol, triglycerides, smoking cessation, etc.

Full Information

First Posted
June 28, 2023
Last Updated
July 13, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT05955950
Brief Title
Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction
Acronym
GReATCARE
Official Title
Gratitude Intervention in Promoting Self-care and Improving Negative Psychological States in Patients With Acute Myocardial Infarction: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
November 5, 2023 (Anticipated)
Study Completion Date
July 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Positive psychological's constructs have shown a direct effect on adherence to pharmacological treatment, diet, physical activity and general commitment to health, in the same way that negative ones, such as depression, anxiety and stress, are associated with worse cardiovascular outcomes and are prevalent in patients with infarction. Objective: To verify whether a gratitude intervention can improve self-care and improve negative psychological states in patients with recent myocardial infarction. Methods: Randomized, parallel clinical trial. The inclusion criteria will be patients with ST-segment elevation myocardial infarction (STEMI) with less than 12 hours of evolution and undergoing primary percutaneous coronary intervention (pPCI). Participants will respond to the socio-demographic and risk factors questionnaire and self-care (ASA-A), anxiety, depression and stress (DASS-21) and gratitude (QG-6) scales. They will be drawn into the gratitude intervention group or neutral events group according to the randomization list. Patients in the intervention group will be tasked with writing down 3 to 5 situations a day for which they are grateful, for 14 days. Patients in the control group will be asked to write down 3 to 5 situations a day that have impacted them, whether good or bad. Both groups will be reassessed after the intervention and after 6 months. Expected results: It is expected that the intervention group will improve self-care and the feeling of gratitude, modify behaviors and decrease negative affects, while the group without intervention will remain unchanged from the beginning of the study to 6 months.
Detailed Description
Study design: Randomized, parallel clinical trial. The study will use a prospective experimental design with Condition and Time as independent variables. The condition has two levels that correspond to the experimental conditions: (a) Gratitude List (aspects of daily experience that one feels grateful for), (b) Any Event List (events of one's own choosing that impressed the participant during the day, whether positive or negative). Time is a repeated measures variable with three levels corresponding to the measurement times: (a) Pre-test (before the intervention), (b) Post-test (at 2 weeks after of the intervention - visit 1) and (c) ) Follow-up (from baseline to 6 months - visit 2). This follow-up period is based on the previous studies. Patients will be invited to participate in the study during hospitalization for AMI. If they agree to participate, they must sign the Free and Informed Consent Form. They will answer the socio-demographic questionnaire and risk factors and self-care scales (ASA-A), anxiety, depression and stress (DASS-21) and gratitude (QG-6). Envelopes will be opened after the initial interview. Participants will receive instructions for the intervention. Participants will be asked to allocate 10-20 minutes at the end of the day, before bed, for 14 days, to write the lists, according to their allocation group. Studies involving gratitude interventions generally last for two weeks as already explained. In each group, participants will make a list of up to five items, evaluating the activities of that day. The instructions for the groups were adapted and translated. For the intervention group (Gratitude List), the instructions will be: "During the day, many things happen in our lives, big and small, for which we can be grateful. Think about your day and write down up to five things in your life that you are grateful for." For the control group (List of any event), the instructions were: "During the day, there are many events in our lives, big and small, that end up affecting us. Think about your day and write down up to five things in your life that affected you." Patients will receive a small notebook for daily notes, starting on the day of discharge. Upon discharge, text messages will be sent to their cell phones with reminders not to forget to start and continue making lists. At the end of 2 weeks of the intervention, patients will be invited to return for a reassessment interview (visit 1), and again at the end of 6 months (visit 2). A 6-month follow-up will be necessary so that we can assess changes in behavior. To assess the improvement in self-care, the ASA-A scale will be used. To assess emotional factors, the DASS scale (which assesses anxiety, depression and stress) will be used. To assess gratitude in the face of life events, the QG-6 scale and for physical health, a dedicated questionnaire will be used. All scales will be used before and after.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute
Keywords
Psychosocial intervention, positive psychology, mental health, self-care,, Myocardial infarction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel clinical trial. The study will use a prospective experimental design with Condition and Time as independent variables. The condition has two levels that correspond to the experimental conditions: (a) Gratitude List (aspects of daily experience that one feels grateful for), (b) Any Event List (events of one's own choosing that impressed the participant during the day, whether positive or negative). Time is a repeated measures variable with three levels corresponding to the measurement times: (a) Pre-test (before the intervention), (b) Post-test (at 2 weeks after of the intervention - visit 1) and (c) ) Follow-up (from baseline to 6 months - visit 2).
Masking
Outcomes Assessor
Masking Description
Neither the researcher nor the participants will be blind to the group to which they were allocated. Because the first will give the necessary guidance and the second will have knowledge of the existing groups through the TCLE and at the time they receive the instructions. Blinding will only occur for the research participant (scientific initiation scholarship holder or volunteer) who must carry out the return interviews and the application of the questionnaires soon after the end of the intervention and in the 6-month follow-up. Primary outcome: Self-care and negative psychological states Secondary outcomes: Change in behavior (physical activity, diet...) and gratitude.
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gratitude List
Arm Type
Experimental
Arm Description
Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for.
Arm Title
List of any event
Arm Type
Active Comparator
Arm Description
Participants must to write 3-5 words a day for 14 days about events of your own choosing that impressed the participant during the day, whether positive or negative.
Intervention Type
Behavioral
Intervention Name(s)
Gratitude list
Intervention Description
Participants must to write 3-5 words a day for 14 days about aspects of their daily experience that they are grateful for.
Intervention Type
Behavioral
Intervention Name(s)
List of any event
Intervention Description
Participants must to write 3-5 words a day for 14 days about events of your own choosing that impressed the participant during the day, whether positive or negative.
Primary Outcome Measure Information:
Title
Changes in self-care scores
Description
Changes in self-care scores assessed from Appraisal of Self-care Agency (ASA)
Time Frame
From baseline to 15 days and from baseline to 6 months
Title
Changes in negative psychological states
Description
Changes in DASS-21 scores
Time Frame
From baseline to 15 days and from baseline to 6 months
Secondary Outcome Measure Information:
Title
Changes in gratitude scores
Description
Changes in Gratitude Questionnaire - GQ-6 scores
Time Frame
From baseline to 15 days and from baseline to 6 months
Title
Behavioral changes (physical activity, diet...)
Description
Changes in modifiable cardiovascular risk factors: cholesterol, triglycerides, smoking cessation, etc.
Time Frame
From baseline to 15 days and from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ST-segment elevation myocardial infarction (STEMI) patients Undergoing primary percutaneous coronary intervention (pPCI). Exclusion Criteria: Patients in need of ventilatory support; Over 75 years of age; Delirium or dementia reported by the attending physician. Not able to answer the questionnaires. Very high depression scores requiring referral to psychological care services
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCIA M SCHMIDT
Organizational Affiliation
Institute of Cardiology of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcia Moura Schmidt
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction

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