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Comparison the Effect of Peer Support with Health Care Support Through Cyberspace on Family Care Burden and Self-Efficacy in Adolescents with Type 1 Diabetes

Protocol summary

Study aim
Comparison the Effect of Peer Support with Health Care Support through Cyberspace on Family Care burden and Self-Efficacy in Adolescents with type 1 Diabetes
Design
A clinical trial with two intervention groups and one control group, single blind and 90 sample size
Settings and conduct
The study is single blind. Statistical analyst will be unaware of intervention groups (intervention 1 and 2) and control. Intervention group one: adolescents receiving peer support through cyberspace for three months. Intervention group: adolescents receiving health care support through cyberspace for three months. Adolescent control group finds routine activities in Akbar hospital of Mashhad.
Participants/Inclusion and exclusion criteria
Entry requirements:1-Willingness to participate in the study. 2-Written parental consent to participate in the study. 3-Type 1 diabetes, at least 6 months. 4-Ability to use smartphones and cyberspace (social networks). 5-Minimum elementary education. 6-No other chronic comorbidities. 7-Not passing similar peer support courses 8-years 12 to 18 years. Exclusion criteria: Not having high conditions; leave the group or being inactive for a long time.
Intervention groups
For adolescents in intervention group one, Peer-to-peer support will run for three months (at least three times a week) Intervention group two, cybersecurity support will run for three months (at least three times a week). For the control group, routine measures will be taken during Akbar Hospital in Mashhad.The self-care-support content is designed for diabetes care. This content is being shared with peers to use their subgroups in addition to their experiences in self-care.
Main outcome variables
Self-efficacy of adolescents (Areas of diet, medication use, physical activity and blood glucose measurement); family care burden (objective and subjective dimension).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200224046602N1
Registration date: 2020-04-10, 1399/01/22
Registration timing: registered_while_recruiting

Last update: 2020-04-10, 1399/01/22
Update count: 0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Zohreh Faramarzizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3509 8501
Email address
faramarzizadehz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Peer Support with Health Care Support Through Cyberspace on Family Care Burden and Self-Efficacy in Adolescents with Type 1 Diabetes
Public title
Comparison the Effect of Peer Support with Health Care Support Through Cyberspace on Family Care Burden and Self-Efficacy in Adolescents with Type 1 Diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum elementary education Written parental consent to participate in the study Ages 12-18 Ability to use smartphones and cyberspace Type 1 diabetes at least 6 months Parental consent to participate in the study
Exclusion criteria:
Confirmed disease or chronic comorbidities Attend peer support similar courses
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Statistical analyst will be unaware of intervention groups (intervention 1 and 2) and control.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad School of Midwifery Nursing, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.102

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Efficacy
Timepoint
At baseline and 3 months later
Method of measurement
Diabetes Management Self-efficacy Questionnaire (DMSES

2

Description
Family care burden
Timepoint
At baseline and 3 months later
Method of measurement
Family Caring Bar Questionnaire (CBI)

Secondary outcomes

1

Description
The economic situation
Timepoint
At baseline and 3 months later
Method of measurement
Monthly income status and patient spending less than adequate, adequate, more than adequate (based on officially declared poverty line

2

Description
Economic situation
Timepoint
At baseline and 3 months later
Method of measurement
Monthly income status and patient spending less than adequate, adequate, more than adequate (based on officially declared poverty line

3

Description
Underlying diseases
Timepoint
At baseline and 3 months later
Method of measurement
Patient with other chronic diseases other than type 1 diabetes

4

Description
Blood sugar
Timepoint
At baseline and 3 months later
Method of measurement
blood test

5

Description
Insulin consumption
Timepoint
At baseline and 3 months later
Method of measurement
Investigation of patient records

Intervention groups

1

Description
Intervention group1:Adolescents receiving peer support through cyberspace for three months (at least three times a week)
Category
Lifestyle

2

Description
Intervention group2: Adolescents receiving health care support through cyberspace for three months (at least three times a week)
Category
Lifestyle

3

Description
Control group: No extra work
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Shahr Hospital of Mashhad
Full name of responsible person
Rezaian َAramesh
Street address
Shahid Fakouri Boulevard- Akbar Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9186818831
Phone
+98 51 3763 1506
Email
faramarzizadehz1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rabab Latifnejad Rudsari
Street address
Doctoral Ave- Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
NMS.IT@mums.ac.ir
Web page address
https://nurse.mums.ac.ir/assistances/res-vice/r-v-intro
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaian
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Midwifery Nursing, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
00985138591511051
Email
NMS.IT@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaeian
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Midwifery Nursing, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
NMS.IT@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaeian
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Midwifery Nursing, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
NMS.IT@mums.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
All data can be shared after unidentifiable individuals
When the data will become available and for how long
Start of access period 3 months after publication of results
To whom data/document is available
Researchers and nurses working in medical institutes of Iran
Under which criteria data/document could be used
Use of research results is permitted
From where data/document is obtainable
faramarzizadehz1@mums.ac.ir
What processes are involved for a request to access data/document
As soon as possible after emailing
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