Type 2 DiabetesNCT05822349
Effect of Using Pictograms on Improving Depression and Anxiety Among Type 2 Diabetic Patients.
A study testing picograms-enriched label in people with Type 2 Diabetes, run by University of Jordan at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- picograms-enriched label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteJordan
- Study dates
- 1 Apr 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Northern Badya Hospital
Al Mafraq, 25110
Esraa M AL Sbaihat, 0779036395 ext. +962, israa8190637@yahoo.com
About this study
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.
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.
- Conditions
- Type 2 Diabetes
- Being tested
- picograms-enriched label
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
picograms-enriched labelBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | they will receive the usual diabetes care routine plus a pictogram-enriched label. Receives: Behavioral: picograms-enriched label |
| control group | Placebo comparator | they will receive the usual diabetes care routine. Receives: Behavioral: picograms-enriched label |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in depression level
Patient Health Questionnaire-9 (PHQ-9)
Measured: 12 weeks following ends of intervention
change in anxiety level
Generalized Anxiety Disorder scale (GAD-7)
Measured: 12 weeks following ends of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa AL Sbaihat, University of Jordan
- Investigators
- AL-Motassem F Yousef, Study director, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822349
- Sponsor's protocol ID
- MOH/REC/2022/411
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05822349
- Acronym / sponsor ID
- MOH/REC/2022/411
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Behavioral: picograms-enriched labelthey will receive the usual diabetes care routine plus a pictogram-enriched label. |
| control group | Placebo comparator | Behavioral: picograms-enriched labelthey will receive the usual diabetes care routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| picograms-enriched labelThe 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). | Behavioural | control group, intervention group |
Primary outcome
change in depression level
Time frame: 12 weeks following ends of intervention
Patient Health Questionnaire-9 (PHQ-9)
change in anxiety level
Time frame: 12 weeks following ends of intervention
Generalized Anxiety Disorder scale (GAD-7)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AL-Motassem F Yousef study director
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing picograms-enriched label in people with Type 2 Diabetes, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa M AL Sbaihat (0779036395 ext. +962, israa8190637@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in depression level (time frame: 12 weeks following ends of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.