Comparison of impact of Pictorial and Teach-back educational strategies on knowledge about diabetes disease, adherence to medication and diet among people with diabetes type 2 and low health literacy attending to diabetes unit of Imam Khomeini hospital in saqqez
(1) Objectives: to examine the impact of Pictorial and Teach-back educational strategies on knowledge about diabetes disease, adherence to medication and diet among people with diabetes type 2 and low health literacy attending to diabetes unit of Imam Khomeini hospital in saqqez.
(2) Design: a randomized clinical trial
(3) Setting and Conduct: 127 people with diabetes type 2 and low health literacy from Unit of Diabetes, Imam Khomeini Hospital in Saqqez were enrolled and allocated to three arms of study (control, Pictorial and Teach-back groups). Questionnaires was used to gathering demographic data, the level of functional health literacy in adults (TOFHLA), knowledge on the subject of diabetes, adherence to medication and diet. The validity and reliability of Questionnaires were assessed and confirmed through content validity and test- retest methods. Data analysis was performed using ANOVA and Paired t test in SPSS software version 16.
(4) Participants including major eligibility Criteria: Inclusion criteria
Obtaining health literacy score<59; afflicted to Diabetes type 2; age over 18; able to read and write;
Exclusion criteria
Lack of dementia; visual or learning disability; no afflicted to diabetes type one; no participation in other research project.
(5) Intervention: intervention groups received diabetes education by Teach Back and Pictorial methods respectively, the control group received regular diabetes education offered by Diabetes Unit.
(6) Main Outcome Measures: knowledge on the subject of diabetes, adherence to medication and diet.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201108684N1
Registration date:2012-02-07, 1390/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-07, 1390/11/18
Registrant information
Name
Reza Negarandeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 1685
Email address
rnegarandeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2011-10-07, 1390/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of impact of Pictorial and Teach-back educational strategies on knowledge about diabetes disease, adherence to medication and diet among people with diabetes type 2 and low health literacy attending to diabetes unit of Imam Khomeini hospital in saqqez
Public title
comparison of two educational methods
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
obtain health literacy score<59; afflicted to Diabetes type 2; age over 18; able to read and write;
Exclusion criteria
lack of dementia; visual or learning disability; no afflicted to diabetes type one; no participation in other research project.
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
135
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Blvd.,Tehran
City
Tehran
Postal code
Approval date
2010-08-08, 1389/05/17
Ethics committee reference number
599/130/د/89
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E10-E11- E
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Knowledge about Diabetes Disease
Timepoint
Before and six weeks after finishing intervention
Method of measurement
Researcher developed questionnaire for knowledge
2
Description
adherence to Diet
Timepoint
Before and six weeks after finishing intervention
Method of measurement
Researcher developed questionnaire for diet
3
Description
adherence to medication
Timepoint
Before and six weeks after finishing intervention
Method of measurement
Morisky standard questionnaire for adherence to medication
Secondary outcomes
empty
Intervention groups
1
Description
Pictorial educational strategy is a method that educator use of pictorial for teaching Key concepts without using medical terminology or jargons.
Category
Other
2
Description
Participants in control group were received only routine diabetes education.
Category
N/A
3
Description
Teach-back educational strategies
Teach-back is a way to confirm that you have
explained to the patient what they need to know in a manner that the patient
understands. Patient understanding is confirmed when they explain it back to
you.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Unit of Diabetes, Imam Khomeini Hospital in Saqqez
Full name of responsible person
Hassan Mahmoodi
Street address
Unit of Diabetes, Imam Khomeini Hospital, Saqqez, Iran.
City
Saqqez
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Vice chancellor for Research
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Vice chancellor for Research, Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Vice chancellor for Research
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Negarandeh
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Tohid Sq., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6642 1685
Fax
Email
rnegarandeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Negarandeh
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Tohid Sq., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6642 1685
Fax
+98 21 6642 1685
Email
rnegarandeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)