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Investigating the Effect of Adherence to Therapeutic Regimen program on the Quality of Life in Patients with Atrial Fibrillation

Protocol summary

Study aim
Determining the effect of an adherence to a therapeutic regimen program on the quality of life of patients with atrial fibrillation arrhythmia hospitalized in the Shahid Chamran Educational-Medical hospital of Isfahan in 2018
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed
Settings and conduct
The study environment is the CCU, Post CCU, and Internal Cardiology units of Isfahan, Shahid Chamran Educational-Medical Center.
Participants/Inclusion and exclusion criteria
Those patients with atrial fibrillation arrhythmia diagnosed and treated by the cardiologist specialists.
Intervention groups
The intervention group: A compiled therapeutic regimen program which is a synthesis of personal training and practicing in two 45-minute successive sessions. On the second and third days of hospitalization, during the hours 9 to 11, and with the aid of illustrated pictures of an educational booklet, there will be face to face discussions between the patients and the researcher on the arrhythmia type, the therapeutic method, the used drugs and their side effects, the amount of activity, how to face psychological problems, the significance of conducting coagulation tests, the type of nourishing, and a plan to correctly face probable problems. The control group: This group will receive the usual cares besides a personal 30-minute session concerning the atrial fibrillation disease. One month after the intervention, a researcher colleague possessing no information on the study purposes will fill out the questionnaire via the questioning method and by the use of data included in the histories of the experimental and control groups.
Main outcome variables
The enhancement of the quality of life of patients with atrial fibrillation, the enhancement of the management in face of disease signs and symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190203042608N1
Registration date: 2019-12-29, 1398/10/08
Registration timing: retrospective

Last update: 2019-12-29, 1398/10/08
Update count: 0
Registration date
2019-12-29, 1398/10/08
Registrant information
Name
fatemeh Yazdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3624 8911
Email address
yazdizadeh.f71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-15, 1396/10/25
Expected recruitment end date
2018-06-15, 1397/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Adherence to Therapeutic Regimen program on the Quality of Life in Patients with Atrial Fibrillation
Public title
Investigating the Effect of Adherence to Therapeutic Regimen program on the Quality of Life in Patients with Atrial Fibrillation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
7- The Main Inclusion criteria in the Study before Randomization Those patients with atrial fibrillation arrhythmia diagnosed and treated by cardiologist specialists. Those patients with atrial fibrillation arrhythmia hospitalized for the first time. Those patients that are in the age range between 35 and 70 years old
Exclusion criteria:
Patients’ disinclination to participate in the intervention Patients’ with physical and psychological problems leading to their disabilities 3. Patients below 35 years old and above 70 years old
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: 50
Randomization (investigator's opinion)
Randomized
Randomization description
To collect data, having obtained the required permissions accompanied with the authorities’ agreement and cooperation, the researcher refers to the CCU, Post CCU, and internal cardiology units of the Chamran Hospital and extracts the list of patients with atrial fibrillation arrhythmia introduced by the cardiologist specialists in these units. Then, she talks to all patients having the inclusion criteria, and, in addition to introducing herself, she explains them the purpose of the study. Finally, the qualified samples for the study are simply selected, and, having acquired their written informed consent, we will include them in the study. The randomization is implemented as the following: the samples are given numbers from the list of random numbers, and, according to the numbers, the even ones are assigned to the experimental group and the odd ones are assigned to the control group. This task continues until the considered sample number is achieved.
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
The Ethics Committee of Isfahan, University of Medical Sciences
Street address
The Headquarters, Isfahan, University of Medical Sciences and Healthcare Services, Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.MUI.REC.396635

Health conditions studied

1

Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48.1
ICD-10 code description
Persistent atrial fibrillation

Primary outcomes

1

Description
The quality-of-life in patients with atrial fibrillation in the AFEQT questionnaire
Timepoint
Investigating the quality of life at the study outset, one month and three months after the intervention
Method of measurement
The atrial fibrillation effect on the quality-of-life questionnaire

Secondary outcomes

1

Description
The atrial fibrillation symptoms including heartbeat, chest pain, shortness of breath, and vertigo
Timepoint
All items accomplished before the intervention, and one month and three months after the intervention
Method of measurement
All items are from the atrial fibrillation effect on the quality-of-life questionnaire for the patients with atrial fibrillation

Intervention groups

1

Description
A compiled therapeutic regimen program which is a synthesis of personal training and practicing in two 45-minute successive sessions. On the second and third days of hospitalization, during the hours 9 to 11, and with the aid of illustrated pictures of an educational booklet, there will be face to face discussions between the patients and the researcher on the arrhythmia type, the therapeutic method, the used drugs and their side effects, the amount of activity, how to face psychological problems, the significance of conducting coagulation tests, the type of nourishing, and a plan to correctly face probable problems. At the end of the second session, the experimental group will be given an educational booklet concerning the presented issues in adherence to a therapeutic regimen program. The telephone call happens between 8 in the morning and 8 at night on certain dates and times according to the agreement between the researcher and the patient and its content is encouraging the presented discussions in the sessions, question and answer, reinforcing the lessons, and the disease management power. Then, there will be no intervention for 8 weeks. Finally, 12 weeks after the intervention, the questionnaire will be filled out by the educational colleague.
Category
Diagnosis

2

Description
Control group: This group will receive the usual cares besides a personal 30-minute session concerning the atrial fibrillation disease. One month after the intervention, a researcher colleague possessing no information on the study purposes will fill out the questionnaire via the questioning method and by the use of data included in the histories of the experimental and control groups
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan, Shahid Chamran Educational-Medical Center
Full name of responsible person
Fatemh Yazdizadeh
Street address
Salman Farsi Street after the city bridge
City
Isfahan
Province
Isfehan
Postal code
7346181748
Phone
+98 83 3835 8258
Email
yazdizadeh.f71@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahin Moeini
Street address
Central headquarters, Isfahan, University of Medical Sciences and Healthcare Services, Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
7346181756
Phone
+98 83 3835 8258
Email
moeini@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Yazdizadeh
Position
An M.A. Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Number 5, Palestine Boulevard the 16th
City
Shirvan
Province
Razavi Khorasan
Postal code
9461658685
Phone
+98 83 3835 8258
Email
yazdizadeh.f71@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Yazdizadeh
Position
An A.M. student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Number 5, Palestine Boulevard the 16th
City
Shirvan
Province
Razavi Khorasan
Postal code
9461658685
Phone
+98 936 845 2985
Email
yazdizadeh.f71@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatima Yazdizadeh
Position
An M.A. student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Number 5, Palestine Street 16th
City
Shirvan
Province
Razavi Khorasan
Postal code
9461658685
Phone
+98 83 3835 8258
Email
yazdizadeh.f71@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The entire data present in the questionnaire is sharable after it becomes unidentifiable
When the data will become available and for how long
The accessibility onset is up to 5 years after printing the results
To whom data/document is available
It will be accessible to all researchers working in scientific and academic institutions
Under which criteria data/document could be used
The resultant documents can be referred to in similar studies on the patients with atrial fibrillation, the effect of regimen according to demographic variables, and similar issues
From where data/document is obtainable
Referring to the library of the nursing faculty and receiving the electronic file of the thesis The personal e-mail of the researcher Fatima Yazdizadeh: yazdizadeh.f71@gmail.com
What processes are involved for a request to access data/document
The document appliers should have valid student number from their university or ethics code from the respected university. Moreover, they should present the full specifications of their advisors while they receive the documents so that they can hold them for two weeks.
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