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The effect of education based on Pender's Health Promotion Model on quality of life and medication adherence among patients with Implantable Cardioversion Defibrillator

Protocol summary

Study aim
The effect of education based on Pender’s Health Promotion Model on quality of life and medication adherence among patients with Implantable Cardioversion Defibrillator
Design
A randomized clinical trial with 66 participants by continuous sampling method which will be allocated to 33 control and intervention group by block randomization method using Sealedenvelope.com
Settings and conduct
Orienting session at dischargement from Shahid Rajai Cardiovascular Institute in Tehran, five virtual training sessions on Skype twice a week by the researcher based on Pender's health promotion model concepts, weekly phone calls Hospital nurses and all participants and their families are unaware of control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Ability to read and write, An Ejection Fraction over 35%, Absence of underlying chronic diseases affecting quality of life including cancer, stroke, chronic kidney disease, severe diabetes mellitus with HbA1C over 7.5, Absence of psychological disorders Exclusion criteria: Deterioration of the clinical condition in a way that disrupts the participation in the research, Not participating in more than two sessions
Intervention groups
The control group will receive the hospital's dischargement educational program including educational pamphlets by the nurse. The intervention group will receive a 45-minute session about the study process by the researcher at the time of dischargement. The next five virtual 30 minute training sessions will be held on Skype twice a week based on Pender's health promotion model concepts. Also, weekly phone calls will be held for one month to follow up on the recommendations.
Main outcome variables
Improving quality of life and medication adherence Increasing health promotion behavior, reducing frequent visits, hospitalizations and sudden death among research community

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240309061231N1
Registration date: 2024-04-10, 1403/01/22
Registration timing: prospective

Last update: 2024-04-10, 1403/01/22
Update count: 0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Niloofar Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4411 3145
Email address
ahmadi.ni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on Pender's Health Promotion Model on quality of life and medication adherence among patients with Implantable Cardioversion Defibrillator
Public title
The effect of education based on Pender's Health Promotion Model on quality of life and medication adherence among patients with Implantable Cardioversion Defibrillator
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Ability to read and write An Ejection Fraction over 35% Absence of underlying chronic diseases affecting quality of life including cancer, stroke, chronic kidney disease, severe diabetes mellitus with HbA1C over 7.5 Absence of psychological disorders
Exclusion criteria:
Deterioration of the clinical condition in a way that disrupts the participation in the research Not participating in more than two educating sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are allocated to two groups of control and intervention using Block randomization and in order to prevent the predictability of blocks, blocks with a variable number of 4,6,8 will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
At the time of discharge, all samples are being trained by their nurse. Therefore, these nurses and all participants are unaware about the control and intervention groups. Also, during one of the intervention sessions, the sample is educated in the presence of a family member. These family members are also unaware of the existence of control and intervention groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Central Headquarters Building, Research and Technology Vice-Chancellor, Hemmat Highway, next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
Approval date
2024-04-02, 1403/01/14
Ethics committee reference number
IR.IUMS.REC.1403.002

Health conditions studied

1

Description of health condition studied
Pender's health promotion model, Quality of life, Medication adherence, Implantable Cardioversion Defibrillator
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of quality of life in Minnesota living with heart failure questionnaire (MLHFQ)
Timepoint
At the beginning of the study (before the intervention), At the end of the study (two month after the intervention)
Method of measurement
Minnesota living with heart failure questionnaire (MLHFQ)

2

Description
The score of medication adherence in Morisky Medication Adherence Scale (MMAS-8)
Timepoint
At the beginning of the study (before the intervention), At the end of the study (two month after the intervention)
Method of measurement
Morisky Medication Adherence Scale (MMAS-8)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The participants will be included in the study through continuous sampling method and according to the inclusion and exclusion criteria, and will be allocated to the intervention and control groups using the block randomization method. In addition to the usual training during dischargement by the nurse, the intervention group will receive a 45-minute orienting session about the study process, the number and the way of conducting training sessions, and five other sessions twice a week according to the concepts of Pender's health promotion model. Also, to follow-up on the trained recommendations, phone calls will be held once a week during a month. Study questionnaires will be collected from the samples before and at the end of the intervention.
Category
Other

2

Description
Control group: The participants will be included in the study through continuous sampling method and according to the inclusion and exclusion criteria, and will be allocated to the intervention and control groups using the block randomization method. The control group will only receive the usual training during dischargement from hospital, which includes educational pamphlets and training by the nurse. Study questionnaires will be collected from the samples before and at the end of the intervention. Finally, in order to consider the ethical principles, the educational content of the intervention group will also be given to the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Rajai Cardiovascular Medical and Research Institute
Full name of responsible person
Mohammad Abbasi
Street address
Shaheed Rajai Cardiovascular Medical and Research institute, Vali Asr Ave, Niayesh Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
mohamad_abbasi55@yahoo.com
Web page address
http://rhc.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemmat Highway, next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
Mohamad_abbasi55@yahoo.com
Web page address
https://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Niloofar Ahmadi
Position
Nurse,BSN, MSN student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 23, Seven west street, Norouzi Ave, Eastern farsad, Javanmardan Blvd, Shahre Ziba, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1487614745
Phone
+98 21 4411 3145
Fax
Email
Ahmadiniloo77@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Abbasi
Position
Dean's professor of Nursing and Midwifery school
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasemi St. Valiasr St. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
Mohamad_abbasii55@yahoo.com
Web page address
https://fnm.iums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Niloofar Ahmadi
Position
Nurse,BSN, MSN student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 23, Seven west street, Norouzi Ave, Eastern farsad, Javanmardan Blvd, Shahre Ziba, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1487614745
Phone
+98 21 4411 3145
Fax
Email
Ahmadiniloo77@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
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
Not applicable
Title and more details about the data/document
Due to the educational nature of the intervention, all the information collected through the questionnaires can be shared after making samples unidentifiable. Also, the clinical study report as the title of "Materials and Methods" and statistical analyzes can also be shared.
When the data will become available and for how long
It is possible to access the data and results since the results are published in the form of a thesis.
To whom data/document is available
Since the samples are made unidentifiable, all people can receive the data in the thesis.
Under which criteria data/document could be used
The research data can only be used to improve the education of the research community or to compare with the effectiveness of other educational methods.
From where data/document is obtainable
IUMS Nursing-Midwifery school's library: School of Nursing & Midwifery Rashid Yasemi St. Vali Asr St. Tehran, Iran; libfnm@iums.ac.ir; Phone 00982143651101; Post box 1996713883. Prof. Mohmmad Abbasi, Faculty member, Dean's professor: Phone 00989125270638; mohamad_abbasi55@yahoo.com Niloofar Ahmadi, BSN, MSN student: Phone 00989129263778; Ahmadiniloo77@gmail.com
What processes are involved for a request to access data/document
If the applicant lives in Tehran, Islamic Republic of Iran, he/she can refer to Nursing-Midwifery school's library and collect the desired data. If the applicant does not live in Tehran or needs more information about the study data, he/she can send an email to Prof. Mohammad Abbasi as mohamad_abbasi55@yahoo.com. In case of being unable to contact the professor, please send an email to Niloofar Ahmadi as Ahmadiniloo77@gmail.com.
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