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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05822349
Other study ID # MOH/REC/2022/411
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date August 1, 2023

Study information

Verified date April 2023
Source University of Jordan
Contact Esraa M AL Sbaihat
Phone 0779036395
Email israa8190637@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 204
Est. completion date August 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
picograms-enriched label
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).

Locations

Country Name City State
Jordan Northern Badya Hospital Mafraq

Sponsors (1)

Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in depression level Patient Health Questionnaire-9 (PHQ-9) 12 weeks following ends of intervention
Primary change in anxiety level Generalized Anxiety Disorder scale (GAD-7) 12 weeks following ends of intervention
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