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Effect of face-to-face education versus virtual education on self-care and quality of life in patients with heart failure: a randomized clinical trial

Protocol summary

Study aim
To assess the effect of face-to-face education versus virtual education on self-care and quality of life in patients with heart failure
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Farshchian Heart Hospital in Hamadan city on 80 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 25 to 70 years Heart failure Heart ejection fraction less than 40% Exclusion criteria: Psychological problems Physical disability (hearing or visual)
Intervention groups
Intervention group: Sending recorded self-care training files through WhatsApp for 30 minutes once a day for 8 days, including: explanation of heart function, understanding heart disease and its complications, diet and medication management, sodium and fluid restriction, importance and how to weigh daily, regular exercise, monitoring of signs and symptoms of exacerbation of the disease, non-smoking, social activities, sexual activity, taking medications, following medical instructions and avoiding self-medication. Control group: Face-to-face self-care training for 60 minutes every other day for 8 days including: explanation of heart function, understanding heart disease and its complications, diet and medication management, sodium and fluid restriction, importance and how to weigh daily, regular exercise, monitoring of signs and symptoms of exacerbation of the disease, non-smoking, social activities, sexual activity, taking medications, following medical instructions and avoiding self-medication.
Main outcome variables
Primary outcome: Self-care, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N430
Registration date: 2022-06-15, 1401/03/25
Registration timing: prospective

Last update: 2022-06-15, 1401/03/25
Update count: 0
Registration date
2022-06-15, 1401/03/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-10-25, 1401/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of face-to-face education versus virtual education on self-care and quality of life in patients with heart failure: a randomized clinical trial
Public title
Effect of face-to-face education versus virtual education on self-care and quality of life in patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25 to 70 years Heart failure Heart ejection fraction less than 40%
Exclusion criteria:
Psychological problems Physical disability (hearing or visual) Having a medical education
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Sending recorded self-care training files through WhatsApp for 30 minutes once a day for 8 days, including: explanation of heart function, understanding heart disease and its complications, diet and medication management, sodium and fluid restriction, importance and how to weigh daily, regular exercise, monitoring of signs and symptoms of exacerbation of the disease, non-smoking, social activities, sexual activity, taking medications, following medical instructions and avoiding self-medication.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-06-11, 1401/03/21
Ethics committee reference number
IR.UMSHA.REC.1401.224

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Evaluation of patients' self-care
Timepoint
Before and 2 months after the intervention
Method of measurement
using Jarasma standard questionnaire

2

Description
Evaluation of patients' quality of life
Timepoint
Before and 2 months after the intervention
Method of measurement
Using the standard Minnesota questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Sending recorded self-care training files through WhatsApp for 30 minutes once a day for 8 days, including: explanation of heart function, understanding heart disease and its complications, diet and medication management, sodium and fluid restriction, importance and how to weigh daily, regular exercise, monitoring of signs and symptoms of exacerbation of the disease, non-smoking, social activities, sexual activity, taking medications, following medical instructions and avoiding self-medication.
Category
Treatment - Other

2

Description
Control group: Face-to-face self-care training for 60 minutes every other day for 8 days including: explanation of heart function, understanding heart disease and its complications, diet and medication management, sodium and fluid restriction, importance and how to weigh daily, regular exercise, monitoring of signs and symptoms of exacerbation of the disease, non-smoking, social activities, sexual activity, taking medications, following medical instructions and avoiding self-medication.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Mohsen Ahmadi
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
pedonconurse69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohsen Ahmadi
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
pedonconurse69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Azim Azizi
Position
PhD in Nursery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azimazizi1360@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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