purpose: the Determination of effect of self care education based on family-center empowerment model on self care beheviors and hemoglobin A1C in type 1 diabetes patient.
Design:Quasi-experimental, randomized , Single-center
The study population: Patients with type 1 diabetes, 12 to 18 years old, Referred to Iranian Diabetes Association whodivided into two groups Randomly . The experimental group received self-care education and The control group did not receive any training .
The sample size: 80
intervention: self care education in In three areas: Nutrition, exercise and physical activity , and use of insulin and control Complications based on four steps ( perceived threat , problem solving , educational participation and evaluation ) family-centered empowerment model in 5 sessions of 90 minutes
time of study: 1394
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051322258N1
Registration date:2015-08-07, 1394/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-07, 1394/05/16
Registrant information
Name
Mahdieh Azizi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
m.azizi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education based on family-center empowerment model on self-care behaviors and HbA1C in patients with Type 1 Diabetes
Public title
the effect of self care in diabetes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:1. definitive diagnosis of type I diabetes by a physician , 2.Are in the age range 18-12, 3. having tendency to participate in study
Exclusion criteria: 1. Have no desire to continue participating in the study
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Kudkyar deadlock, Daneshjoo boulevard, Evin street
City
Tehran
Postal code
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
IR.USWR.REC.1394.37
Health conditions studied
1
Description of health condition studied
type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self care
Timepoint
Before the intervention and 1/5 month after intervention
Method of measurement
Self-care behaviors questionnaire
2
Description
Hemoglobin A1C
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Self-care education in the areas of nutrition, exercise and physical activity and control of Complications and drug use based on step of (Perceived threat , problem solving , educational partnership and Evaluation) family-center empowerment model, In five sessions 90 minutes
Category
Lifestyle
2
Description
control group: did not receive any training.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Diabetes Association
Full name of responsible person
Mahdieh Azizi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Narges Arsalani
Street address
Kudkyar deadlock , Daneshjoo boulevard, Evin street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Narges Arsalani
Position
Nursing PhD/ Assistant Professor
Other areas of specialty/work
Street address
Kudkyar beadlock , Daneshjoo boulevard, Evin street
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
nargesarsalani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Narges Arsalani
Position
PHD
Other areas of specialty/work
Street address
Kudkyar deadlock , Daneshjoo boulevard, Evin street
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
nargesarsalani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mahdieh Azizi
Position
Student
Other areas of specialty/work
Street address
Kudkyar deadlock , Daneshjoo boulevard, Evin street
City
Tehran
Postal code
Phone
+98 21 2236 0018
Fax
Email
Mis.azizi1369@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)