Determining the effect of peers digital storytelling on the sense of belonging in people with type 1 diabetes
Design
This is a single-blind randomized clinical trial study using software on 60 patients with type 1 diabetes.
Settings and conduct
This study will be conducted in the health centers of Isfahan city and the collected data will be analyzed after coding by a researcher who is not aware of the control and intervention groups.
Participants/Inclusion and exclusion criteria
1. Adults with type 1 diabetes for at least 6 months 2. Lack of physical disability such as blindness or deafness 3. Not taking psychiatric drugs 4. Minimum reading and writing literacy 5. Access to social media and access to the Internet 6. No addiction to drugs, psychedelics and alcohol 7. No disease besides diabetes as approved by the attending physician and according to the contents of the medical file
Intervention groups
The study is two groups. In the intervention group, people with type 1 diabetes participate in peer digital storytelling sessions. In the control group, they receive routine services from the centers.
Main outcome variables
Sense of belonging
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170625034743N4
Registration date:2024-05-01, 1403/02/12
Registration timing:prospective
Last update:2024-05-01, 1403/02/12
Update count:0
Registration date
2024-05-01, 1403/02/12
Registrant information
Name
Leila Mardanian Dehkordi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7541
Email address
mardanian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of peers digital storytelling on the sense of belonging of people with type 1 diabetes
Public title
Evaluate the effect of peers digital storytelling on the sense of belonging of people with type 1 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Adults with type 1 diabetes for at least 6 months
2. Willingness to participate in research
3. Persian-speaking
4. Lack of physical disability such as blindness or deafness
5. Not taking psychiatric drugs
6. Minimum reading and writing literacy
7. Access to social media and access to the Internet
8. No addiction to drugs, psychedelics and alcohol
9. No disease besides diabetes as approved by the attending physician and according to the contents of the medical file
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in two steps. First, as a cluster of centers covered by comprehensive health service centers in the city of Isfahan, according to the equality of the covered centers, 5 centers are randomly selected (lottery) and if no sample is provided, one center is randomly added.
Then, from each center according to the proportional allocation method (based on the ratio of type 1 diabetic patients covered by that center to the total number of diabetic patients in the selected centers, this ratio is observed in the sampling) through the Sib system and from Al Ibrahim's specialized clinic. Through the existing list, eligible patients are selected to enter the study and are randomly placed into two experimental and control groups through the software
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who conducts the data analysis will be unaware of the control and intervention groups and will analyze the data that has been coded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezarjarib Street, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-04-22, 1403/02/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1403.016
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Sense of belonging
Timepoint
Before intervention and quickly and one month after intervention
Method of measurement
Sense of belonging questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the participants complete demographic and sense of belonging questionnaires before starting the study, and then receive peer digital stories during 4 weekly sessions. Immediately and one month after the end of the intervention, the questionnaire are filled out again by the participants.
Category
Treatment - Other
2
Description
Control group: In the control group, demographic and sense of belonging questionnaires are completed before the start of the study, and the participants receive the usual care and counseling provided by health centers and clinics. At the end (immediately and one month after the end of the intervention) sense of belonging questionnaire are completed again by the participants. At the end of the study, digital stories will be provided to the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan comprehensive health service centers
Full name of responsible person
Hamid Galehdari
Street address
Deputy of health district, next to Amin Hospital, Ibn Sina St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8148653374
Phone
+98 31 3447 6060
Email
health@mui.ac.ir
Web page address
https://phc.mui.ac.ir
2
Recruitment center
Name of recruitment center
Al Ibrahim Diabetes Clinic
Full name of responsible person
Ahmad Nilforoushan
Street address
East Balal St., Lahore St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8154645731
Phone
+98 31 3225 8444
Email
diabets_ngo@yahoo.com
Web page address
http://www.diabet-charity.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Deputy of Research and Technology, Building No.4, Isfahan University of Medical Sciences and Health Services, HazarJarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
askari@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
Sheyda Zamani
Position
Nursing student in Master Science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7541
Email
sheydazamani1377new@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Mardanian Dehkordi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7541
Email
leila.mardanian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Mardanian Dehkordi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7541
Email
mardanian@nm.mui.ac.ir
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 collected data will be published in a paper
When the data will become available and for how long
1 year after study
To whom data/document is available
Reviewers and authors of the article
Under which criteria data/document could be used
Data are available from the authors upon reasonable request with the permission of [name of third party].
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
Request from corresponding author through an email