Online Psychological Support Group for Patients With Heart Failure and Depression

Sponsor
Instituto de Cardiologia do Rio Grande do Sul (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05948241
Collaborator
(none)
132
1
2
19
6.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Online psychological support group
  • Other: Standard multidisciplinary care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Online Psychological Support Group for Patients With Heart Failure and Depression in Promoting Self-care: a Randomized Clinical Trial
Actual Study Start Date :
May 5, 2022
Actual Primary Completion Date :
Aug 5, 2022
Anticipated Study Completion Date :
Dec 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Changes in Beck Depression Inventory Scores (BDI-II) [From baseline to 4 months]

    Changes in depression scores

  2. Changes in Morisky and Green points [From baseline to 4 moths]

    Changes in adherence points

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marcia Moura Schmidt Porto Alegre Rio Grande Do Sul Brazil 90620-000

Sponsors and Collaborators

  • Instituto de Cardiologia do Rio Grande do Sul

Investigators

  • Principal Investigator: MARCIA M SCHMIDT, IC-FUC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT05948241
Other Study ID Numbers:
  • UP 5977/21
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 17, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2023