Online Psychological Support Group for Patients With Heart Failure and Depression

Not Applicable

Active, not recruiting

• Conditions: Heart Failure; Depression

• Registration Number: NCT05948241
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-05
• Primary Completion: 2022-08-05
• Status Verified: 2023-06
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17
• Study Completion: 2023-12-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in European Heart Failure Self-Care Behavior Scale's Scores	From baseline to 4 months	Changes in Self-care scale scores

Secondary Outcome Measures

Name	Time	Method
Changes in Morisky and Green points	From baseline to 4 moths	Changes in adherence points
The average hospitalization's days in 1 year follow up	From baseline to 1 year follow up	The average hospitalization days in 1 year follow up for all causes heart failure related
Changes in Beck Depression Inventory Scores (BDI-II)	From baseline to 4 months	Changes in depression scores

Trial Locations

Locations (1)

Marcia Moura Schmidt; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil