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Investigating the effect of implementing the 5A self-management model on the understanding of the facts of heart diseases and adherence to the treatment regimen in patients with type 2 diabetes under the comprehensive health service centers of Isfahan 1402

Protocol summary

Study aim
Determining the effect of the implementation of A5 self-management model on the understanding of the facts of cardiovascular diseases and adherence to treatment regimen in type 2 diabetes patients.
Design
In a clinical trial with a control group, with parallel groups, without blinding, randomized, on 70 people with type 2 diabetes, a systematic method is used for randomization.
Settings and conduct
The research population is type 2 diabetes patients who will be selected systematically. The setting of the intervention is the comprehensive health service centres of Isfahan City. One centre is randomly selected and assigned to the intervention group, and then from among the centres If the social and economic conditions are Similar with the centre of the intervention group, one centre will be randomly selected and the subjects of the control group will be selected in it. The intervention group will receive the educational program based on the 5A self-management model in 5 stages. It includes review, guidance, agreement, assistance and follow-up. The control group will receive routine care.
Participants/Inclusion and exclusion criteria
The main inclusion criteria: suffering from type 2 diabetes, at least one year has passed since the diagnosis of type 2 diabetes. Major conditions for Exclusion criteria: unwillingness to participate in the study, cardiovascular disease, not suffering from cardiovascular disease, cognitive disorders, and mental retardation.
Intervention groups
The study has two groups. The intervention group receives the educational program based on the 5A self-management model, and the control group receives heroin care.
Main outcome variables
Adherence to the treatment regimen, Understanding the facts of heart diseases

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130801014242N4
Registration date: 2023-06-16, 1402/03/26
Registration timing: prospective

Last update: 2023-06-16, 1402/03/26
Update count: 0
Registration date
2023-06-16, 1402/03/26
Registrant information
Name
Maryam Shirazi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2904
Email address
m_shirazi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementing the 5A self-management model on the understanding of the facts of heart diseases and adherence to the treatment regimen in patients with type 2 diabetes under the comprehensive health service centers of Isfahan 1402
Public title
The effect of the 5 A self-management model on the understanding of the facts of heart diseases and adherence to treatment regimen
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be Persian speaking. At least one year has passed since the definitive diagnosis of type 2 diabetes Do not have any underlying disease that hinders speech and understanding, including cognitive, visual, and motor sensory diseases such as severe depression, mental retardation, and Parkinson's. Have minimum reading and writing literacy. Have an active file in comprehensive health service centers of Isfahan city. Be Iranian.
Exclusion criteria:
Aggravation of the disease from the time of the phone call to the time of attending the center to complete the questionnaires and perform the intervention that leads to hospitalization or death of the samples. Cardiovascular diseases The patient does not want to cooperate in the study.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in three stages. In the first stage, between Isfahan health network one and Two, one of the centre's number one or two will be chosen randomly (tossing a coin) and then the list of comprehensive health service centres of this centre will be prepared. In the second stage, a centre will be selected by lottery as the intervention group, and the control group to be homogenous in terms of social and economic conditions with the subjects of the intervention centre, among the comprehensive health service centres listed in the vicinity of the centre of the intervention group, A centre will be selected as a control group by drawing lots. In the third stage, in the centres selected by the researcher, through the Sib system, the head of the centre will prepare a list of all the people who meet the criteria for entering the study and will systematically select the subjects, in such a way that first, the total number of the population Divide the research by the required number of subjects to get the K number. Then randomly, the first number below ten is obtained, which is called n. Then the numbers N+K, N+2K, N+3K,... will be selected until the last subject.
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 Isfahan University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.028

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Adherence to treatment regimen score in the Modanlo questionnaire/Score of understanding the facts of heart diseases in the Wegener heart disease facts questionnaire
Timepoint
At the beginning of the study, immediately and 2 months after the start of the intervention
Method of measurement
Questionnaires of the facts of Wegener's heart disease and adherence to Modanlo's treatment regimen

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before starting the study, the intervention group completed demographic questionnaires, understanding the facts of heart diseases and adhering to the treatment regimen, and for them, a self-management program based on the 5A model is implemented in 5 stages. The 5 stages include examination, guidance, agreement, help and follow-up. The first 3 stages will be held individually and the 4th stage will be held in groups of 8 to 12 people for 1 to 2 hours in the form of peer group training. The follow-up stage will also be done by phone. At the end (immediately and two months after the intervention), the questionnaires on understanding the facts of cardiovascular diseases and adherence to the treatment regimen will be completed again in the intervention group.
Category
Treatment - Other

2

Description
Control group: Control group: Before starting the study, the control group will complete demographic questionnaires, understand the facts of heart diseases and adhere to the treatment regimen, and will receive the usual care. At the end (immediately and two months after the intervention), the questionnaires of understanding the facts of cardiovascular diseases and adherence to the treatment regimen will be completed again in the control group. After the intervention, at the end of the study, the educational content will be provided to the control group and a training session will be held for this group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan comprehensive health service centers
Full name of responsible person
Maryam Shirazi
Street address
Health Vice District, next to Amin Hospital, Ibn Sina St, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8148653374
Phone
+98 31 3447 6060
Email
health@mui.ac.ir
Web page address
https://phc.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Fax
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.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
Maryam Shirazi
Position
Instructor, faculty member of Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2904
Fax
+98 81 7376 8471
Email
m_shirazi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Instructor, faculty member of Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2904
Fax
+98 81 7376 8471
Email
m_shirazi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Instructor, faculty member of Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2904
Fax
+98 81 7376 8471
Email
m_shirazi@nm.mui.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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