The effect of peer coaches education on self care activities and its related confidence in adolescents with type 1 diabetes mellitus: a randomized controlled trial
(1) Objectives: The effect of peer coaches education on self care activities and its related confidence in adolescents with type 1 diabetes mellitus. (2) Design: This study is a randomized clinical trial with two groups (intervention and control). Because of lack of similar studies, the sample size will be measure by pilot studies. The participants will collect with inclusion and exclusion criteria and assign randomly to experimental and control groups. (3) Setting and conduct: four session educational intervention in 2 hours for 4 day with group discussion, question and answer For adolescents who have been selected as coach of the Iranian Diabetes Association will be in Tehran. Then three sessions a week part provide will by the same instructor in the adolescents to other adolescents center. (4) Participants: adolescents with type 1 diabetes mellitus that have Inclusion and exclusion. (5) Intervention: These interventions designed for adolescents by the questions in scale. Before and one month after the last training session, the Summary of Diabetes Self-Care Activities Questionnaire and The Confidence in Diabetes Self-Care Scale will be completed by the all adolescents (intervention and control group). (6) Main outcome measures variables: self care activities and its related confidence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060912264N2
Registration date:2014-08-01, 1393/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-01, 1393/05/10
Registrant information
Name
Farahnaz Abdollahzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 0648
Email address
abdollahzadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences (Seyed kazem Shakori)
Expected recruitment start date
2013-08-24, 1392/06/02
Expected recruitment end date
2013-10-05, 1392/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer coaches education on self care activities and its related confidence in adolescents with type 1 diabetes mellitus: a randomized controlled trial
Public title
The effect of peer coaches education on self care activities and its related confidence in adolescents with type 1 diabetes mellitus: a randomized controlled trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion of and adolescents with peer educators to study:
● A diagnosis of diabetes؛
● Being aware of the diagnosis of type I diabetes؛
● Having medical records in Iranian Diabetes Society؛
● Having age between 13 to 18 years؛
● They should last at least 15 months after the diagnosis of type 1 diabetes؛
● The ability to read and write؛
● Access to telephone؛
● No other pathological or chronic illness؛
Adolescents with Specific inclusion of for study entry:
● Diabetes and endocrinology specialist, medical records and confirmed that they were not able to control the disease؛
Specific entry inclusion of to the study of peer educators:
● Diabetes and endocrinology specialist in their medical records confirmed that they were able to control the disease؛
● Sufficient information regarding a diabetes self-care in adolescents and its control method؛
● Ability to communicate with peers؛
Adolescents with peers and exclusion of the study:
● Failure at any stage of the study questionnaire؛
● Not participate in training sessions؛
● Participation in another study؛
Age
From 13 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Not
Secondary trial Id
Not
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of medical sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
5138947977
Approval date
2013-08-08, 1392/05/17
Ethics committee reference number
9270
Health conditions studied
1
Description of health condition studied
Type 1 diabetes mellitus
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Self-care education to adolescents with type I diabetes
Timepoint
Before and one mounth after intervention
Method of measurement
Summary of Diabetes Self-Care Activities Questionnaire
Secondary outcomes
1
Description
Confidence in Diabetes Self-Care
Timepoint
Before and one mounth after intervention
Method of measurement
The Confidence in Diabetes Self-Care Scale
Intervention groups
1
Description
The intervention group trained will be provided by the researcher in adolescents with type I diabetes as peer educators 4 training sessions this week will be a 2-hour intervals. Also, a clinical psychologist in a 2-hour training sessions will for peer educators to provide young people with communication. Then the peer educators will train other young people with diabetes 3 sessions of 2 hours of physical education a week and will be held one week apart, will be used the content of the training sessions and pamphlets, lectures and practical exercises and questions and answers.
Category
N/A
2
Description
And usual care control group by the third meeting held on 3 consecutive days and 4 hours will receive. The teaching methods and the use of the booklet.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic department of Iran
Full name of responsible person
Dr. Asadolah Rajab
Street address
Diabetic department of Iran, Patris lomombar Street, Satarkhan Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research Deputy in Tabriz University of Medical Sceinces
Full name of responsible person
Dr. Seyed Kazem Shakouri
Street address
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research Deputy in Tabriz University of Medical Sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.
Full name of responsible person
Elham Nasiri
Position
Masters of Sciences student
Other areas of specialty/work
Street address
Kosar Dormitory, South Shariati Avenue
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
elham.nurse90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.
Full name of responsible person
Farahnaz Abdollahzadeh
Position
Master of Sciences
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, South Shariati Avenue