Back to resultsEffect of Using Pictograms on Improving Depression and Anxiety Among Type 2 Diabetic Patients.
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
picograms-enriched label
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Participants are eligible if they are Jordanian adults, aged 18 or older, who have been clinically diagnosed with T2DM for at least 6 months, having low health literacy (Individuals who obtained 66 or lower scores in the full TOFHLA instrument are considered as individuals with "low literacy" in the study) [24], come personally for the refill. Exclusion Criteria: Patients who are unable to communicate verbally (aphasic or with hearing impairment), those with any visual, learning disabilities, and psychological or hepatorenal disease (according to the clinical diagnosis by a physician), and those deemed too ill or frail to attend the clinic, and who have participated in other diabetes education research projects will be excluded.
Sites / Locations
- Northern Badya HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
intervention group
control group
Arm Description
they will receive the usual diabetes care routine plus a pictogram-enriched label.
they will receive the usual diabetes care routine.
Outcomes
Primary Outcome Measures
change in depression level
Patient Health Questionnaire-9 (PHQ-9)
change in anxiety level
Generalized Anxiety Disorder scale (GAD-7)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05822349
Brief Title
Effect of Using Pictograms on Improving Depression and Anxiety Among Type 2 Diabetic Patients.
Official Title
Impact of Using Pictograms as an Educational Strategy on Improving Patient Depression and Anxiety Among Low Health Literate Patients With Type 2 Diabetes at Northern Badya Hospital, Jordan.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
we will study the impact of using pictograms on improving depression and anxiety among type 2 diabetic patients, we suppose that patients who received pictograms-enriched labels will have lower levels of depression and anxiety in comparison with those who will not receive after three month follow-up evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
they will receive the usual diabetes care routine plus a pictogram-enriched label.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
they will receive the usual diabetes care routine.
Intervention Type
Behavioral
Intervention Name(s)
picograms-enriched label
Intervention Description
The intervention care includes usual care (instructions for using each anti-diabetic drug) plus pictograms that show how much medications should be taken at each time of day (morning, noon, evening, and night), how to take them in relation to meals, the purpose of the drug, and the most important non-pharmacologic interventions for diabetic patients (weight loss, exercise, avoiding smoking, blood sugar controlling).
Primary Outcome Measure Information:
Title
change in depression level
Description
Patient Health Questionnaire-9 (PHQ-9)
Time Frame
12 weeks following ends of intervention
Title
change in anxiety level
Description
Generalized Anxiety Disorder scale (GAD-7)
Time Frame
12 weeks following ends of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants are eligible if they are Jordanian adults, aged 18 or older, who have been clinically diagnosed with T2DM for at least 6 months, having low health literacy (Individuals who obtained 66 or lower scores in the full TOFHLA instrument are considered as individuals with "low literacy" in the study) [24], come personally for the refill.
Exclusion Criteria:
Patients who are unable to communicate verbally (aphasic or with hearing impairment), those with any visual, learning disabilities, and psychological or hepatorenal disease (according to the clinical diagnosis by a physician), and those deemed too ill or frail to attend the clinic, and who have participated in other diabetes education research projects will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa M AL Sbaihat
Phone
0779036395
Ext
+962
Email
israa8190637@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AL-Motassem F Yousef
Organizational Affiliation
University of Jordan
Official's Role
Study Director
Facility Information:
Facility Name
Northern Badya Hospital
City
Mafraq
ZIP/Postal Code
25110
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esraa M AL Sbaihat
Phone
0779036395
Ext
+962
Email
israa8190637@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Using Pictograms on Improving Depression and Anxiety Among Type 2 Diabetic Patients.
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