Online Psychological Support Group for Patients With Heart Failure and Depression

NCT05948241 | Unknown

• 1 other identifier: UP 5977/21
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Depression

Outcome Measures

Primary Outcomes (1)

• Changes in European Heart Failure Self-Care Behavior Scale's Scores

  Changes in Self-care scale scores

  From baseline to 4 months

Secondary Outcomes (3)

• Changes in Beck Depression Inventory Scores (BDI-II)

  From baseline to 4 months

• Changes in Morisky and Green points

  From baseline to 4 moths

• The average hospitalization's days in 1 year follow up

  From baseline to 1 year follow up

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

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

Online psychological support group

EXPERIMENTAL

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

Interventions

Online psychological support group OTHER

1. 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. 2. 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

Online psychological support group

Standard multidisciplinary care OTHER

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.

Standard treatment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Patients with dementia
• Communication barriers
• Octogenarians
• People unable to access the internet for the intervention
• Who declined to participate;

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Marcia Moura Schmidt

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Depression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• MARCIA M SCHMIDT

  IC-FUC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 17, 2023
• Study Start: May 5, 2022
• Primary Completion: August 5, 2022
• Study Completion: December 5, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)