Online Psychological Support Group for Patients With Heart Failure and Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05948241
• Other study ID #: UP 5977/21
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: December 5, 2023

Study information

• Verified date: June 2023
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: December 5, 2023
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Heart Failure

Intervention

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
• 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.

Locations

Country	Name	City	State
Brazil	Marcia Moura Schmidt	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in European Heart Failure Self-Care Behavior Scale's Scores	Changes in Self-care scale scores	From baseline to 4 months
Secondary	Changes in Beck Depression Inventory Scores (BDI-II)	Changes in depression scores	From baseline to 4 months
Secondary	Changes in Morisky and Green points	Changes in adherence points	From baseline to 4 moths
Secondary	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