The study aimed to determine the effect of family psychoeducation on family burden and self-care behaviors of adolescence with type 1 diabetes.Design: This study is a clinical trial with two groups of participants,include diabetic adolescents ages 12 to 18 years of age and accompanied by a member of the family.Setting and conduct: family psychoeducation for eight two-hour sessions for a month by lecture and discussion procedure will be provided for family members and adolescents. Major Inclusion and Exclusion criteria: The participants included adolescents with type I diabetes and a member of their family, who have the conditions of entering and exiting to the study. Interventions: Interventions will be for mental training to diabetic adolescents and their family members. Educational content based on material contained in the questionnaires is intended. glycolisis hemoglobin blood samples will be taken before the intervention. The questionnaire of the burden of care and self-care behaviors will be completed by adolescents and their family members, and three months later blood samples will be taken and questionnaires will be completed again . The main outcome variable: burden of care and self-care behaviors in adolescents with type 1 diabetes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121525532N1
Registration date:2016-03-01, 1394/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-01, 1394/12/11
Registrant information
Name
Behnam Frahmandnia
Name of organization / entity
Joundi Shapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
arvaneh.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Ahvaz Jundishapur university of medical sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Invastage Effect of Family Psychoeducation on the burden of family care and self-care behaviors in adolescents with type 1 diabetes
Public title
Effect of Family Psychoeducation on the burden of family care and self-care behaviors in adolescents with type 1 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria; non-risk adolescent patients to long-term complications of diabetes (retinopathy, nephropathy, neuropathy) spent at least one year of patient medical diagnostic Declaration willingness to participate in training programs; Exclusion criteria; the occurrence of any social crisis, the family during the study - hospitalization or acute illness-absenteeism at meetings of more than 2 times
Age
From 82 years old to 94 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
based on teenagers attending in golestan diabetes clinic creating the list of people and grouping randomize based on odd and even numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jundishapur Ahvaz University of Medical Sciences
Street address
Department of Development Ahvaz Jundishapur University of Medical Sciences, Highway Golstan, Ahvaz
City
Ahvaz
Postal code
15794-61357
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.AJUMS.REC.1394 .457
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
Family psychoeducation
Timepoint
Before the intervention, three months after the intervention and six months after intervention
Method of measurement
Diabetes Family Impact - Scale(DfI-S)
Secondary outcomes
1
Description
family burden
Timepoint
Before the intervention, three months after the intervention and six months after intervention
Method of measurement
Diabetes Family Impact - Scale(DFI-S)
2
Description
Self - care behaviors of adolescence
Timepoint
Before the intervention, three months after the intervention and six months after intervention
Method of measurement
Self- report Measure Of type 1 Diabetes for adolescents(SMOD-A)
Intervention groups
1
Description
Intervention group: Family psychoeducation for 8 sessions, each session lasting 90 minutes and will run twice a week for groups. Trading sessions include members with one another, as is the process of working group sessions and topics include speech problems in the treatment of diabetes, the role of patients and their families in disease management, diet, exercise, monitoring blood glucose and oral health, diabetes and psychological issues, etc. during each session, the topic of the meeting will be reviewed before. At the end of the training burden of care and self-care questionnaires will be completed by both groups. The HbA1C blood sugar test done during the three and six months for groups.
Category
Lifestyle
2
Description
Control group: no intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital diabetic clinic
Full name of responsible person
Frahmandnia behnam
Street address
Golestain hospital, Golestain, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research JondiShapour University of Medical Sciences
Full name of responsible person
Saki Nader
Street address
ground floor, Vice chancellor for research Joundishapur Ahvaz, university of medical sciences
City
Ahvaz
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 JondiShapour University of Medical 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
JondiShapour University of Medical Sciences
Full name of responsible person
Frahmandnia behnam
Position
nursing post graduat
Other areas of specialty/work
Street address
JondiShapour University of Medical Sciences, highway Golestain, Ahvaz
City
Ahvaz
Postal code
009861357-15794
Phone
+98 61 3373 8331
Fax
Email
frahmandb@gmail.com; Arvaneh.y@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jondi Shapour University of Medical Sciences
Full name of responsible person
Dashtbozorgi bahman
Position
post graduat nursing
Other areas of specialty/work
Street address
61 Number, Street 5 Industries, industry Area, Golestain highway, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
bahnurse@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jondi Shapour University of Medical Sciences
Full name of responsible person
Frahmand nia behnam
Position
Student post graduat nursing
Other areas of specialty/work
Street address
Ahvaz higway Golestan University of Medical Sciences Jundishapur
City
Ahvaz
Postal code
009861357-15794
Phone
+98 61 3373 8383
Fax
Email
frahmandb@gmail.com; Arvaneh.y@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)