Protocol summary

Study aim
Determining the impact of multimedia training on the lifestyle and understanding of the disease of patients with atrial fibrillation
Design
A controlled, parallel-group, randomized, community-based, practice-oriented clinical trial.
Settings and conduct
The place where the study was conducted was the CCU department of Ayatollah Kashani and Hajar hospitals in Shahrekord city. The study population was patients with atrial fibrillation. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definitive diagnosis; Admitted to the CCU of Shahrekord Kashani and Hajer hospitals. Non-inclusion criteria: age less than 35 years and more than 70 years; Atrial fibrillation patients with a pacemaker
Intervention groups
Intervention group: Two training sessions will be held through multimedia software (sound, video, image and animation) under the title of 1-hour training workshop for patients on a coordinated date and time in one of the platforms available on the web.Control group: the routine program of the special department is implemented.
Main outcome variables
Disease perception; lifestyle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181122041720N3
Registration date: 2022-08-05, 1401/05/14
Registration timing: registered_while_recruiting

Last update: 2022-08-05, 1401/05/14
Update count: 0
Registration date
2022-08-05, 1401/05/14
Registrant information
Name
Shirin Madadkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 2382
Email address
shirinmadadkar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of multimedia education with the Luntal model approach based on telephone follow-up (telenursing) in comparison with routine CCU care on improving the lifestyle and understanding of the disease of patients with atrial fibrillation
Public title
Investigating the effect of education among atrial fibrillation patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of a cardiologist in the case of atrial fibrillation and fixed rhythm Hospitalized in the ccu department of Kashani and Hajar Shahrekord Hospital Ability to communicate by phone The ability to speak in Farsi and not have speech, hearing, or vision problems
Exclusion criteria:
Patients under 35 years old and over 70 years old Atrial fibrillation patients with a pacemaker
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly placed in the mentioned groups (intervention and control). In this way, each patient is given a number from 1 to 60 and the patients are randomly assigned to two groups A (intervention) and B (control) using a table of random numbers.
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
Shahrekord branch of Islamic Azad University
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.IAU.SHK.REC.1401.010

Health conditions studied

1

Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
life style
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Walker's HPLP2 health-enhancing lifestyle questionnaire

2

Description
Disease perception
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Illness Perception Questionnaire IPQ-R

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, two training sessions will be held through multimedia software (sound, video, image and animation) under the title of 1-hour training workshop for patients on a coordinated date and time in one of the platforms available on the web.In the intervention group, in addition to educational workshops, telephone intervention is also conducted by the researcher for 1 month (once a week).
Category
Prevention

2

Description
Control group: There is no intervention in the control group and only all nursing routine care is received.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Shirin Madadkar
Street address
Ayatollah Kashani Hospital Hagar Shahrekord; Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
Kashani@skums.ac.it

2

Recruitment center
Name of recruitment center
Hagar Shahrekord Hospital
Full name of responsible person
Shirin Madadkar
Street address
Hospital Hagar Shahrekord; Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Phone
+98 38 3222 0016
Email
info@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshid Khairi
Street address
Islamic Azad University of Shahrekord; Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Deputy of Islamic Azad University, Shahrekord Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Shahrekord; Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 913 977 5406
Email
shirinmadadkar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Shahrekord; Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
shirinmadadkar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Shahrekord; Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
shirinmadadkar@gmail.com

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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