Heart FailureNCT05948241
Online Psychological Support Group for Patients With Heart Failure and Depression
A study testing Online psychological support group and Standard multidisciplinary care in people with Heart Failure and Depression, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Heart Failure, Depression
- What is being tested?
- Online psychological support group and Standard multidisciplinary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- 5 May 2022to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Patients with dementia
- Communication barriers
- Octogenarians
- People unable to access the internet for the intervention
- Who declined to participate;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heart Failure, Depression
- Being tested
- Online psychological support group, Standard multidisciplinary care
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online psychological support groupOther
- 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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Online psychological support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in European Heart Failure Self-Care Behavior Scale's Scores
Changes in Self-care scale scores
Measured: From baseline to 4 months
Secondary outcomes (3)
Changes in Beck Depression Inventory Scores (BDI-II)
Changes in depression scores
Measured: From baseline to 4 months
Changes in Morisky and Green points
Changes in adherence points
Measured: 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
Measured: From baseline to 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start5 May 2022
- Primary completion5 Aug 2022
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCIA M SCHMIDT, Principal investigator, IC-FUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948241
- Sponsor's protocol ID
- UP 5977/21
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Psychological Support Group for Patients With Heart Failure and Depression in Promoting Self-care: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05948241
- Acronym / sponsor ID
- UP 5977/21
- Conditions
- Heart Failure, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Other: Standard multidisciplinary careThe 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. |
| Online psychological support group | Experimental | Other: Online psychological support groupThe 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- Patients with dementia
- Communication barriers
- Octogenarians
- People unable to access the internet for the intervention
- Who declined to participate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online psychological support group1. 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 | Other | Online psychological support group |
| Standard multidisciplinary careThe 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 treatment |
Primary outcome
Changes in European Heart Failure Self-Care Behavior Scale's Scores
Time frame: From baseline to 4 months
Changes in Self-care scale scores
3 secondary outcomes
Changes in Beck Depression Inventory Scores (BDI-II)
Time frame: From baseline to 4 months
Changes in Morisky and Green points
Time frame: From baseline to 4 moths
The average hospitalization's days in 1 year follow up
Time frame: From baseline to 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARCIA M SCHMIDT principal investigator
IC-FUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online psychological support group and Standard multidisciplinary care in people with Heart Failure and Depression, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in European Heart Failure Self-Care Behavior Scale's Scores (time frame: From baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.