The effect of short term health literacy promotion program on self-care behaviors and quality of life among patients with type 2 diabetes: a Randomized Controlled Trial
The purpose of this study is The effect of educational intervention on increasing health literacy, self-care behaviors and quality of life in patients with type 2 diabetes in Chaldoran.
Design
The groups are extracted randomly from the list of patients in the Chaldoran Health Network and they are categorized into groups.The sample size was 40.
Settings and conduct
After selecting the intervention and control groups, the data will be collected using a questionnaire before intervention and 3 and 6 months after the intervention.In the pre-intervention phase, a pre-test is performed in a test group and a control And then by analyzing the data of this stage, resources, limitations, needs and strengths and weaknesses are identified in different fields. And then the educational intervention is designed.
Participants/Inclusion and exclusion criteria
The main inclusion criteria: patients with diabetes, Iranian nationality, absence of formal education about nutrition; exercise and self-care over the past 6 months and consent to participate in the study. Exclusion criteria: having mental disorders such as dementia, Alzheimer's disease and mental retardation; having severe motor constraints such as limb disability; having illnesses such as cardiovascular diseases.
Intervention groups
Intervention group: includes 80 people that the training program will be implemented for them. The number of sessions is 5 and the duration of the training will be one month. Control group: includes 80 people in whom an educational program will not be running.
Main outcome variables
Awareness; health literacy; self-care behaviors; hemoglobin A1c; quality of life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131116015422N7
Registration date:2019-02-25, 1397/12/06
Registration timing:retrospective
Last update:2019-02-25, 1397/12/06
Update count:0
Registration date
2019-02-25, 1397/12/06
Registrant information
Name
Towhid Babazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
t-babazadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-12, 1397/06/21
Expected recruitment end date
2018-12-17, 1397/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of short term health literacy promotion program on self-care behaviors and quality of life among patients with type 2 diabetes: a Randomized Controlled Trial
Public title
The Effect of Health Literacy Improvement on Self-care Behaviors and Quality of Life in Diabetic Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetes
Iranian nationality
Absence of formal education about nutrition, exercise and self-care over the past 6 months
Consent to participate in the study
Exclusion criteria:
Mental disorders such as dementia, Alzheimer's disease, mental retardation
Having severe motor constraints such as limb disability
Having diseases such as cardiovascular disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, a simple random allocation method will be used and patients will be divided into intervention and control groups by lottery. In this way, patients will be numbered without observing the particular order then the patients with odd numbers will be assigned to the intervention group and the patients with even numbers will be assigned in the control group.
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee, Third Floor, Central Building No. 2, Tabriz University of Medical Science, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.TBZMED.REC.1397.459
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Health literacy
Timepoint
Before the intervention, 3 and 6 months after the intervention
Method of measurement
Questionnaire
2
Description
Awareness
Timepoint
Before the intervention, 3 and 6 months after the intervention
Method of measurement
Questionnaire
3
Description
Behavior
Timepoint
Before the intervention, 3 and 6 months after the intervention
Method of measurement
Questionnaire
4
Description
Quality of Life
Timepoint
Before the intervention, 3 and 6 months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
HbA1c
Timepoint
Before the intervention, 3 and 6 months after the intervention
Method of measurement
Lab test
Intervention groups
1
Description
Intervention group: In this group pre-test will be performed and in this study the intervention will be performed through training sessions. The intervention would be based on information obtained from the questionnaire. 5 sessions in a one-month period will be held as follows: Session 1: Understanding the goals of the training program and raising the awareness of patients (40 minutes) Session 2: Increasing patient awareness (45 minutes), Session 3: Promoting Health Literacy (Reading and Understanding Skills, 40 Minutes), Session 4: Improving Health Literacy (Decisions, 30 minutes), Session 5: Improving self-care behaviors (40 minutes).
Category
Behavior
2
Description
Control group: In this group pre-test will be performed but the training is not done and after the end of data collection in the end of study, educational pamphlets will be given to the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Chaldoran Health Network
Full name of responsible person
Hakim Ahmadzadeh Heidaranloo
Street address
Chaldoran Health Network, County Chaldoran, West Azerbaijan province
City
Chaldoran
Province
West Azarbaijan
Postal code
58741-16111
Phone
+98 44 3426 7027
Fax
+98 44 3426 4516
Email
ahmadzade.hakim@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolqasem Jouyban
Street address
Deputy for Research and Technology, Third Floor, Central Building 2, Tabriz University of Medical Sciences, Golgasht, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hakim Ahmadzadeh Heidaranloo
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Fax
+98 41 3336 4658
Email
ahmadzade.hakim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakim Ahmadzadeh Heidaranloo
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Fax
+98 41 3336 4658
Email
ahmadzade.hakim@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakim Ahmadzadeh Heidaranloo
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabrez
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
ahmadzade.hakim@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available