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Online Psychological Support Group for Patients With Heart Failure and Depression

Primary Purpose

Heart Failure, Depression

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Online psychological support group
Standard multidisciplinary care
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with heart failure Age between 18 and 79 years B) After hospital discharge Depression (BDI-II score above 14 points) Acceptance of the Term of Consent; Exclusion Criteria: Patients with dementia Communication barriers Octogenarians People unable to access the internet for the intervention Who declined to participate;

Sites / Locations

  • Marcia Moura Schmidt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard treatment

Online psychological support group

Arm Description

The control group will undergo 1 consultation with the multidisciplinary team, offered as standard treatment at the Heart Failure outpatient clinic of the Institute of Cardiology, with the areas: medicine, nutritionist and psychology. Monitoring with a multidisciplinary team is the gold standard for monitoring patients with HF and its multiple comorbidities. These patients are followed up on average every 3 months in this outpatient clinic.

The intervention group, in addition to standard treatment, will have 1 weekly session in an online psychological support group of 45 minutes each, totaling 12 sessions in three months. The intervention will be carried out by research psychologists specializing in cardiology, with online consultations via whatsapp

Outcomes

Primary Outcome Measures

Changes in European Heart Failure Self-Care Behavior Scale's Scores
Changes in Self-care scale scores

Secondary Outcome Measures

Changes in Beck Depression Inventory Scores (BDI-II)
Changes in depression scores
Changes in Morisky and Green points
Changes in adherence points
The average hospitalization's days in 1 year follow up
The average hospitalization days in 1 year follow up for all causes heart failure related

Full Information

First Posted
June 21, 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
NCT05948241
Brief Title
Online Psychological Support Group for Patients With Heart Failure and Depression
Official Title
Online Psychological Support Group for Patients With Heart Failure and Depression in Promoting Self-care: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
December 5, 2023 (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
Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
The control group will undergo 1 consultation with the multidisciplinary team, offered as standard treatment at the Heart Failure outpatient clinic of the Institute of Cardiology, with the areas: medicine, nutritionist and psychology. Monitoring with a multidisciplinary team is the gold standard for monitoring patients with HF and its multiple comorbidities. These patients are followed up on average every 3 months in this outpatient clinic.
Arm Title
Online psychological support group
Arm Type
Experimental
Arm Description
The intervention group, in addition to standard treatment, will have 1 weekly session in an online psychological support group of 45 minutes each, totaling 12 sessions in three months. The intervention will be carried out by research psychologists specializing in cardiology, with online consultations via whatsapp
Intervention Type
Other
Intervention Name(s)
Online psychological support group
Intervention Description
st Session: Presentation of the participants and the objectives of the group, which are the management of depression and the promotion of self-care. Discussion on heart failure and its clinical management. Arrangements will be made with these patients about confidentiality between the participants, as it is a group intervention where each participant can expose their personal issues. nd Session: Discussion on depression and its clinical management. From the 3rd to the 11th Session: They will aim to offer support for the emotional demands of the participants, related to the daily and future challenges inherent in the care provided with HF, seeking to promote self-care. As it is a homogeneous group, it is expected to enable enriching exchanges within the group about changes in habits or adaptations to HF, since psychological support groups have this function. 12th Session: Closing and evaluation of participants. Scheduling for reassessment of instruments
Intervention Type
Other
Intervention Name(s)
Standard multidisciplinary care
Intervention Description
The control group will undergo 1 consultation with the multidisciplinary team, offered as standard treatment at the Heart Failure outpatient clinic of the Institute of Cardiology, with the areas: medicine, nutritionist and psychology. Monitoring with a multidisciplinary team is the gold standard for monitoring patients with HF and its multiple comorbidities. These patients are followed up on average every 3 months in this outpatient clinic.
Primary Outcome Measure Information:
Title
Changes in European Heart Failure Self-Care Behavior Scale's Scores
Description
Changes in Self-care scale scores
Time Frame
From baseline to 4 months
Secondary Outcome Measure Information:
Title
Changes in Beck Depression Inventory Scores (BDI-II)
Description
Changes in depression scores
Time Frame
From baseline to 4 months
Title
Changes in Morisky and Green points
Description
Changes in adherence points
Time Frame
From baseline to 4 moths
Title
The average hospitalization's days in 1 year follow up
Description
The average hospitalization days in 1 year follow up for all causes heart failure related
Time Frame
From baseline to 1 year follow up

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with heart failure Age between 18 and 79 years B) After hospital discharge Depression (BDI-II score above 14 points) Acceptance of the Term of Consent; Exclusion Criteria: Patients with dementia Communication barriers Octogenarians People unable to access the internet for the intervention Who declined to participate;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCIA M SCHMIDT
Organizational Affiliation
IC-FUC
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

Online Psychological Support Group for Patients With Heart Failure and Depression

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