Online Psychological Support Group for Patients With Heart Failure and Depression

Online Psychological Support Group for Patients With Heart Failure and Depression in Promoting Self-care: a Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Heart Failure
• Intervention / Treatment: Other: Standard multidisciplinary care; Other: Online psychological support group

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-000
      • Marcia Moura Schmidt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard treatment; 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.	Other: Standard multidisciplinary care; 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.
Experimental: Online psychological support group; 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	Other: Online psychological support group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in European Heart Failure Self-Care Behavior Scale's Scores	Changes in Self-care scale scores	From baseline to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Beck Depression Inventory Scores (BDI-II)	Changes in depression scores	From baseline to 4 months
Changes in Morisky and Green points	Changes in adherence points	From baseline to 4 moths
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	From baseline to 1 year follow up

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Investigators: Principal Investigator: MARCIA M SCHMIDT, IC-FUC

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): August 5, 2022
• Study Completion (Estimated): December 5, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Mood Disorders; Heart Failure; Depression; Depressive Disorder
• Other Study ID Numbers: UP 5977/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No