Protocol summary
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Study aim
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Determining the impact of peer-based virtual education on cardiac self-efficacy and self-care of patients with heart failure
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Design
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A randomized, parallel-group, controlled clinical trial with a sample size of 74 people. First, patients who meet the inclusion criteria will be selected on a convenience basis. Then, they will be randomly assigned to two groups using sealed opaque envelopes.
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Settings and conduct
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Sampling is done in Farshchian Heart Center of Hamadan city, among the patients with heart failure. The test group will be trained in self-care behaviors during eight sessions. These trainings will be online for one month. The control group will not receive any training until the end of the study. Data are collected from both groups using the demographic and self-care questionnaire of heart failure disease and cardiac self-efficacy, before and one month after the intervention, 6 months and one year after the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion and Exclusion Criteria:
Major Inclusion Criteria Before Randomization:
Patients who meet the study's inclusion criteria, which include a diagnosis of heart failure, literacy in using social media, no participation in a similar educational program, and being between 35 and 65 years old, will be selected using convenience sampling.
Major Exclusion Criteria Before Randomization:
Exclusion criteria include participation in a heart disease educational program within the past 6 months and a diagnosis of psychiatric disorders.
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Intervention groups
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The educational materials that have been expressed and recorded by the peers will be provided to the intervention group during eight sessions through virtual space (Ita messenger and WhatsApp) within a month. The control group only received routine training during discharge.
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Main outcome variables
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Selfcare
General information
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Reason for update
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Given that changing self-care behaviors and improving self-efficacy require time, and the learning and institutionalization of these behaviors will change significantly over time, we plan to examine and compare the research variables over a long period of time.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240611062088N1
Registration date:
2024-08-11, 1403/05/21
Registration timing:
registered_while_recruiting
Last update:
2025-03-11, 1403/12/21
Update count:
1
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Registration date
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2024-08-11, 1403/05/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-08-10, 1403/05/20
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Expected recruitment end date
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2025-01-19, 1403/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of peer-based virtual education on cardiac self-efficacy and self-care of patients with heart failure
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Public title
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The effect of peer-based virtual education on cardiac self-efficacy and self-care of patients with heart failure
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Literacy for reading and writing
Heart failure diagnosis confirmed by a cardiologist
Social media literacy
Having the facilities and ability to answer the phone (patient or active member of the patient's family)
Not having a medical diagnosis of depression or anxiety
Not having a history of mental disorders based on the patient's file and speech and hearing problems and cognitive and memory deficits
Membership in virtual networks on a mobile phone (patient or active member of the patient's family) to receive training
Age between 35 and 70
Exclusion criteria:
Participation in heart failure training programs in the last 6 months
Inability to read and write
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Age
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From 35 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
74
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Initially, patients who meet the study's inclusion criteria will be selected using convenience sampling.They will then be randomly assigned to either Group A (the intervention group) or Group B (the control group) using sealed, opaque envelopes. Specifically, 37 cards labeled "A" and 37 cards labeled "B" will be prepared and placed inside the sealed, opaque envelopes. These envelopes will be thoroughly mixed. To allocate patients to Groups A and B, each patient will be asked to randomly select one of the envelopes. Based on the card inside, patients will be assigned to either the test group or the control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-05-11, 1403/02/22
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Ethics committee reference number
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IR.UMSHA.REC.1403.090
Health conditions studied
1
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Description of health condition studied
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Heart failure
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ICD-10 code
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I50
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ICD-10 code description
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Heart failure
Primary outcomes
1
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Description
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Self-care
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Timepoint
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Before and one month after the intervention, 6 months and one year after the intervention
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Method of measurement
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Using a standard self-care questionnaire
Secondary outcomes
1
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Description
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Self-efficacy of cardiac patients
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Timepoint
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Before and one month after the intervention, 6 months and one year after the intervention
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Method of measurement
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Sullivan's standard cardiac self-efficacy questionnaire
Intervention groups
1
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Description
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Intervention group: Sending educational files recorded by peers via WhatsApp or Eitaa for 15-20 minutes for 8 sessions in one month including: explanation of heart function, recognition of heart disease and its complications, diet and drug management, sodium restriction and Fluids, the importance and method of daily weighing, regular exercise, monitoring signs and symptoms of disease exacerbation, not smoking, social activities, sexual activity, taking medications, following medical orders and avoiding self-medication.
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Category
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Treatment - Other
2
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Description
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Control group: Receiving routine trainings during discharge to patients and also receiving educational video files to patients after the end of the research intervention.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available