Diabetes mellitus is a chronic disease with high prevalence and is a growing concern in the world. Several factors in the care of people with chronic diseases such as diabetes that the concept of health literacy known as an important factor on diabet mellitus . Although diabetes is one of the most important socio-economic and health concerns and help diabetics patients for good glycemic control and prevention of complications of disease is related to the patients health literacy and self efficacy . Considering the fact that the relationship between support and family education and diabetes, few studies about patients with type 2 diabetes and most of the research done in this regard on children and youths in Iran, also according to the characteristics unique Iranian families and the culture of governing, little research has been reported in this case.The aim of this study was to determine the effect of family-centered empowerment model on health literacy and self-efficacy in people with type 2 diabetes. Inclusion criteria: age between 20 to 60 years old; no history for mental disorders; diagnosis for diabetes at lease for one year; ability for reading and writing; not attending in another study by Patients and families; living with family; ability to talk and communicate with the family; no serious or debilitating complications of diabetes such as kidney failure and blindness and patient and caregiver agree to participate in the research. Exclusion criteria: no desire to continue cooperation and participate inthe study; be suffering from mental illness or other chronic diseases; not having caregiver for the patients.
In this study, the study population of diabetic patients referred to Imam Ali Shahr-e-Kord clinic was selected from among which 80 patients with type 2 diabetes were selected randomly and then assigned randomly into two groups of control and intervention (each group was 40 patients) .
In control group, routine training are received in the control group, but in the intervention group, family-based care is provided to the patient and the main care giver of the patient (family member), in 6 sessions Family-centered empowerment will take place at intervals of one week and 90 minutes each session.
The data gathering tool in this study was a questionnaireof health literacy and self-efficacy in diabetic patients who evaluated the level of health literacy and self-efficacy in the three stages before, immediately and three months after the intervention.
Data is analyzed using software 23 and statistical tests such as paired t-test, independent t-test, chi-square
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609252861N13
Registration date:2017-10-19, 1396/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Reza Masoodi
Name of organization / entity
Nursing department, Shahrekord University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5654
Email address
masoodi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2016-09-25, 1395/07/04
Expected recruitment end date
2016-12-24, 1395/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Empowering people with type 2 diabetes family-based approach - central
Public title
The Effect of program based onthe family-centered model on health literacy and self-efficacy of people with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 to 60 years old; no history for mental disorders; diagnosis for diabetes at lease for one year; ability for reading and writing; not attending in another study by Patients and families; living with family; ability to talk and communicate with the family; no serious or debilitating complications of diabetes such as kidney failure and blindness and patient and caregiver agree to participate in the research. Exclusion criteria: no desire to continue cooperation and participate in another study during the study; be suffering from mental illness or other chronic diseases; not having caregiver for the patients.
Age
From 20 years old to 60 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
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.SKUMS.REC1395.89
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10-14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Health literacy
Timepoint
Pre intervention, 2 mounths after intervention
Method of measurement
Health literacy questinnaire
2
Description
Self efficacy
Timepoint
Pre intervention, 2 mounths after intervention
Method of measurement
Self efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This program is performed for the intervention group during six sixty-minute sessions and with a constant research team including internist, nurse internist and researcher..In each session, based on the content,paid attention to provide educational content, discuss patient experiences and treatments and illnesses problem.
This care program is presented during discussion sessions Also, through group discussion and telephone counseling, they will be in possession of an educational CD and some of them will be introduced to hospitals or charity associations.The researcher will discuss the treatment and care situation, the defects of their treatment and care knowledge and their support needs in this area, and provide guidance and action.Complete the questionnaire before and immediately after the intervention three months after the intervention.
Category
Behavior
2
Description
The control group only receives routine care and education.
A researcher to observe ethical standards, after the end of the study, for the intervention group, invites control group patients to attend training sessions in a telephone call and Educational CDs (content provided during the Empowerment Program) will be delivered to them.The researcher's phone is also provided to them for further guidance.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic located at the Imam Ali clinic
Full name of responsible person
Fatemeh Ghasemi
Street address
Imam Ali clinic, Shariati blvd.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Sciences
Full name of responsible person
Vice chancellor for research of Shahrekord University of Medical Sciences
Street address
Kashani Blvd-University Headquarters-second floor
City
Shahrekord
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 of Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Fatemeh Ghasemi
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3338 9476
Fax
Email
ghasemi.fatemeh87@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Reza Masoudi
Position
Assisstant Professor/Ph.D in Nursing Education
Other areas of specialty/work
Street address
Nursing And Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
masoodi1383@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Fatemeh Ghasemi
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3338 9476
Fax
Email
ghasemi.fatemeh87@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)