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General information
2022-11-05, 1401/08/14
2026-02-27, 1404/12/08
20222026-1102-0527 00:00:00
2022-12-26, 1401/10/05
2027-03-11, 1405/12/20
20222027-1203-2611 00:00:00
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Due to illness and knee injury, my start of work was delayed for a while. Furthermore, since my place of study is in Isfahan, it was not agreed to start and conduct research outside of Isfahan. On the other hand, my place of work and life is in Karaj, and my leave was not agreed to at work due to my previous sick leave and severe shortage of staff. Therefore, due to the problems that have arisen, the start of my research work and sampling has been delayed. Given the tacit agreement of my place of work to take leave, I will start my research work in Isfahan.
Due to illness and knee injury, my start of work was delayed for a while. Furthermore, since my place of study is in Isfahan, it was not agreed to start and conduct research outside of Isfahan. On the other hand, my place of work and life is in Karaj, and my leave was not agreed to at work due to my previous sick leave and severe shortage of staff. Therefore, due to the problems that have arisen, the start of my research work and sampling has been delayed. Given the tacit agreement of my place of work to take leave, I will start my research work in Isfahan.
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به علت بیماری و آسیب زانو مدتی شروع کار اینجانب به تاخیر افتاد، در ادامه با توجه به اینکه محل تحصیل اینجانب در اصفهان می باشد با شروع و انجام پژوهش در خارج از اصفهان موافقت نشد. از طرفی محل کار و زندگی اینجانب در کرج می باشد و در محل کار با توجه به مرخصی استعلاجی قبلی و با توجه به کمبود شدید نیرو با مرخصی اینجانب موافقت نگردید. لذا با عنایت به مشکلات به وجود آمده، شروع کار پژوهشی و نمونه گیری اینجانب به تاخیر افتاده است. با توجه به موافقت ضمنی محل کار اینجانب جهت مرخصی، کار پژوهشی خود را در اصفهان شروع خواهم کرد.
به علت بیماری و آسیب زانو مدتی شروع کار اینجانب به تاخیر افتاد، در ادامه با توجه به اینکه محل تحصیل اینجانب در اصفهان می باشد با شروع و انجام پژوهش در خارج از اصفهان موافقت نشد. از طرفی محل کار و زندگی اینجانب در کرج می باشد و در محل کار با توجه به مرخصی استعلاجی قبلی و با توجه به کمبود شدید نیرو با مرخصی اینجانب موافقت نگردید. لذا با عنایت به مشکلات به وجود آمده، شروع کار پژوهشی و نمونه گیری اینجانب به تاخیر افتاده است. با توجه به موافقت ضمنی محل کار اینجانب جهت مرخصی، کار پژوهشی خود را در اصفهان شروع خواهم کرد.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice President of University Research and Technology
Full name of responsible person - Persian: معاون تحقیقات و فناوری دانشگاه
Street address - English: Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان، ساختمان شماره 4، معاونت تحقیقات و فناوری
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 3668 7898
Fax:
Email: mousavifar.a@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: ِDr. Gholamreza Askari
Full name of responsible person - Persian: دکتر غلامرضا عسگری
Street address - English: Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان، ساختمان شماره 4، معاونت تحقیقات و فناوری
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 8138
Fax:
Email: research@mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Vice President of University Research and TechnologyِDr. Gholamreza Askari Full name of responsible person - Persian: معاون تحقیقات و فناوری دانشگاهدکتر غلامرضا عسگری Street address - English: Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان، ساختمان شماره 4، معاونت تحقیقات و فناوری City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81746-734618174673461 Phone: +98 31 3668 78988138 Fax: Email: mousavifar.aresearch@gmail.commui.ac.ir Web page address:
Protocol summary
Study aim
Determining the effectiveness of a family-oriented intervention program on treatment adherence in patients with type 2 diabetes
Design
The clinical trial will have a control group, randomized, on 110 patients, and randomization will be done by a statistician using the Balanced Blocked randomization method.
Settings and conduct
The intervention group will receive the family-oriented intervention program under the application for 8 weeks, and the control group will receive the usual diabetes programs in the center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: proven type 2 diabetes; HbA1c level equal to or greater than 7; age range of 18 to 60 years old; literate in reading and writing; have a mobile phone personally or in the family in order to participate in the program; do not have debilitating diseases (such as liver failure, psychological diseases, kidney failure, etc.).
Exclusion criteria: hospitalization during the study for any reason; suffering from serious diseases such as diabetic ketoacidosis or hyperglycemic non-ketogenic hyperosmolar syndrome.
Intervention groups
The intervention group: the group of diabetic patients under family-oriented intervention and the control group: the group of diabetic patients receiving the usual programs of the diabetes center
Main outcome variables
Adherence to treatment
General information
Reason for update
Due to illness and knee injury, my start of work was delayed for a while. Furthermore, since my place of study is in Isfahan, it was not agreed to start and conduct research outside of Isfahan. On the other hand, my place of work and life is in Karaj, and my leave was not agreed to at work due to my previous sick leave and severe shortage of staff. Therefore, due to the problems that have arisen, the start of my research work and sampling has been delayed. Given the tacit agreement of my place of work to take leave, I will start my research work in Isfahan.
Acronym
IRCT registration information
IRCT registration number:IRCT20220907055909N1
Registration date:2022-10-03, 1401/07/11
Registration timing:prospective
Last update:2025-12-23, 1404/10/02
Update count:1
Registration date
2022-10-03, 1401/07/11
Registrant information
Name
Seyedeh Azemat Mousavifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8628
Email address
mousavifar.a@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-02-27, 1404/12/08
Expected recruitment end date
2027-03-11, 1405/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of family-centered intervention program on adherence to treatment in Type 2 Diabetic patients
Public title
Investigating the effect of family-centered intervention on adherence to diabetes treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have type 2 diabetes and their diabetes has been diagnosed and confirmed by a doctor before registration
Have diabetes for at least 6 months
HbA1c level equal to or greater than 7
Be in the age range of 18 to 60 years old
Be literate in reading and writing
Have a phone at home
Have a mobile phone personally or in the family in order to participate in the program
Do not have disabling physical problems and diseases
Are not pregnant and do not intend to become pregnant during the study period
Do not suffer from known psychological diseases
Do not suffer from serious diseases (such as liver failure, kidney failure, etc.)
Willing to participate in the study and complete the informed consent form
Do not currently participate in other research studies.
Family member entry criteria:
Be over 18 years old
Do not have diabetes
Be a First degree family member (wife, child, parent, sister or brother)
Be literate in reading and writing
Willing to participate in the study
Can use a smartphone
Exclusion criteria:
Being hospitalized during the study for any reason
Suffering from diabetic ketoacidosis or hyperglycemic hyperosmolar Nonketotic syndrome
Suffering from serious diseases such as advanced form of cardiovascular diseases, uncontrolled high blood pressure, psychological disorders, severe vision disorders, psychiatry diseases or suffering from physical or mental problems preventing participation in the research
Unwillingness of the patient or family member to participate or continue cooperation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, research samples are first selected based on the available criteria and then randomly (Block Randomization) are divided into intervention and control groups.
In this method, block randomization is used; Blocking is used in order to balance the number of samples allocated to each of the studied groups, so that since we have two groups under study, we use equal blocks of 4 and create all possible states of 4. Then, the sequence of the blocks is determined with the simple randomization service software, and since the sample size in this study is 110 people (55 people in each group), 28 blocks of 4 are used.
Blocked randomization method Balanced and using Sealed Envelope Ltd web software. It is 2020. The method of random allocation is using blocks of size 4. Randomization will be performed by a statistician, who will have no contact with the patients. Researchers and study participants are unaware of the randomization sequence. After confirming the patient's entry into the study, the clinical researcher places the patient in the intervention groups by registering the patient's code based on the determined random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization will be performed by a statistician, who will have no contact with the patients. Researchers and study participants are unaware of the randomization sequence. After confirming the patient's entry into the study, the clinical researcher places the patient in the intervention groups by registering the patient's code based on the determined random sequence.
Placebo
Not used
Assignment
Parallel
Other design features
The studied patients will be examined and compared in 2 groups. A control group is diabetic patients who receive routine care. The family members are present with the patient and in this group the patient and the family member are considered as an intervention unit, the training is provided to the patient himself and the families do not participate in educating and informing the patient and play a passive role or They have a patio. In the intervention group, the family member will participate directly in the clinical care processes. Family members are considered as independent units and direct contributors. In this group, the intervention is done on the family members and the family member plays the main role. In this group, the application is installed on the family member's mobile phone or tablet, the family member is taught how to perform the intervention and how to use it (receiving training and compliance programs for family-oriented treatment through the application) and answers to the existing problems. It will be given. In this group, patients will receive the usual care and family members (not patients) as patient supporters, will receive the necessary training in the field of diabetes control through the installation of the designed application. All educational programs using the application with Various methods such as text, images, videos, listening profile and multimedia are presented to the intervention group and the convenience of family members to receive information is also considered and patients and their family members are advised to Ask any questions or problems regarding how to use the application. In addition to that, training on how to use the application is sent in the form of video and text in the application, and one day after receiving the application, the training will be sent weekly in the application. Submissions will be based on the constructs of awareness, perceived threat, perceived benefits, perceived barriers, perceived self-efficacy, outcome expectations (positive outcomes), self-regulation, and perceived social support. For example, for the perceived threat regarding the complications caused by diabetes, an educational video on foot injury and diabetic foot ulcer will be shown, and the statistics related to leg amputation due to diabetes and lack of blood sugar control will be displayed as a message. Or for self-efficacy in the field of how to perform a daily foot examination by the person himself, it is taught step by step through the video so that the person is able to perform the foot examination alone. Data collection will be done at the beginning of the study and 3 months after the intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Medical University of Isfahan
Street address
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jerib Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-08-22, 1401/05/31
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.189
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Medication compliance score
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Morisky Medication Adherence Scale
2
Description
Physical activity score
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
International Physical Activity Questionnaire (IPAQ )
3
Description
Self-Efficacy Scale
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Diabetes Management Self-Efficacy Scale(DMSES)
4
Description
Self-care behaviors score
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Summary of Diabetes Self Care Activities (SDSCA)
5
Description
Perceived family social support score
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Diabetes Specific Family Support Scale
6
Description
Self-regulation score in treatment
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Treatment Self-Regulation Questionnaire (TSRQ)
Secondary outcomes
1
Description
Glycosylated hemoglobin
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Blood sample test
Intervention groups
1
Description
Intervention group: This group will receive the intervention under the application on the mobile phone for 8 weeks, and all educational programs will be presented to the intervention group using the application in various ways, including text, images, videos, audio profiles, and multimedia.
Category
Behavior
2
Description
Control group: This group will receive the usual programs at the diabetes center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Sedigheh Tahereh Educational, Therapeutic and Research Complex
Full name of responsible person
Seyedeh Azemat Mousavifar
Street address
Ground Floor - Endocrine and Metabolism Research Center - Jomhory Square - Khorram St. - Isfahan- Iran
City
Isfahan
Province
Isfehan
Postal code
81876-98191
Phone
+98 31 3337 3733
Email
mousavifar.a@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ِDr. Gholamreza Askari
Street address
Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
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
Seyedeh Azemat Mousavifar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8628
Email
mousavifar.a@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Azemat Mousavifar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8628
Email
mousavifar.a@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedeh Azemat Mousavifar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8628
Email
mousavifar.a@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
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