Effect of Using Pictograms on Improving Depression and Anxiety Among Type 2 Diabetic Patients.

Sponsor

University of Jordan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05822349

Collaborator

(none)

204

Enrollment

Location

Arms

Anticipated Duration (Months)

50.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: picograms-enriched label	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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.

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intervention group they will receive the usual diabetes care routine plus a pictogram-enriched label.	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).
Placebo Comparator: control group they will receive the usual diabetes care routine.	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).

Arm

Intervention/Treatment

Active Comparator: intervention group

they will receive the usual diabetes care routine plus a pictogram-enriched label.

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).

Placebo Comparator: control group

they will receive the usual diabetes care routine.

Behavioral: picograms-enriched label

Outcome Measures

Primary Outcome Measures

change in depression level [12 weeks following ends of intervention]
Patient Health Questionnaire-9 (PHQ-9)
change in anxiety level [12 weeks following ends of intervention]
Generalized Anxiety Disorder scale (GAD-7)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northern Badya Hospital	Mafraq		Jordan	25110

Sponsors and Collaborators

University of Jordan

Investigators

Study Director: AL-Motassem F Yousef, University of Jordan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Esraa AL Sbaihat, postgraduated student, University of Jordan

ClinicalTrials.gov Identifier:

NCT05822349

Other Study ID Numbers:

MOH/REC/2022/411

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 20, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 20, 2023