Diabetes MellitusSANCT03544645
Are Audiovisual Materials Superior to Printed Materials in Improving Awareness Among Type 2 Diabetic Patients?
A study testing Audiovisual material "video" and Printed material "brochure" in people with Diabetes Mellitus, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Audiovisual material "video" and Printed material "brochure"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Jul 2017to 28 Mar 2018
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients
- Age group from 30 to 70 years
- A1c = 8 mg/dL or above
- Both genders
Who cannot join
- Pregnant women
- Blindness or profound vision loss
- Severe mental problems e.g. Psychosis
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Saud bin Abdulaziz University for Health Sciences
Riyadh, 14611
About this study
Official title: Are Audiovisual Educational Materials Superior to Printed Educational Materials in Improving Insulin Awareness Among Saudi Type 2 Diabetic Patients in Primary Care Setting?
This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. As many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. This research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.
Read the detailed description
Introduction This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. As many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. This research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.
Methodology It's a randomized controlled trial. Validated questionnaire (ITAS) was used to evaluate the psychological insulin barriers, video and Brochures were devolved as educational materials contain same contents and validated. Study conducted in King Abdulaziz city housing with total sample size of 126. They were divided into intervention group (video group) and controlled group (Brochure group). Both group filled the same questionnaire before the intervention. And then immediately after the intervention. Six weeks later, both groups filled the same questionnaire to measure the long-term effects.
- Conditions
- Diabetes Mellitus
- Being tested
- Audiovisual material "video", Printed material "brochure"
- Keywords
- Diabetic Education, audiovisual material, Manual material
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual material "video"Other
an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.
Printed material "brochure"Other
an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | This group received a printed material "brochure" as an educational material Receives: Other: Printed material "brochure" |
| intervention group | Experimental | This group received an audiovisual material "video" as an educational material Receives: Other: Audiovisual material "video" |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the impact of audiovisual educational materials verses printed educational materials
compare intervention versus control on type 2 diabetic patients' knowledge, attitude and practice towards insulin therapy by assessing the patients before, directly after and 6 weeks after the intervention using a validated questionnaire (ITAS) to evaluate the psychological insulin barriers, both intervention and control were devolved as educational materials contain same contents and validated
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start16 Jul 2017
- Primary completion22 Oct 2017
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Alsaif, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544645
- Sponsor's protocol ID
- KingAbdullahIMRC
- Acronym
- SA
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- 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 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Audiovisual Educational Materials Superior to Printed Educational Materials in Improving Insulin Awareness Among Saudi Type 2 Diabetic Patients in Primary Care Setting?
- ClinicalTrials.gov ID
- NCT03544645
- Acronym / sponsor ID
- SA / KingAbdullahIMRC
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetic Education, audiovisual material, Manual material
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 16 Jul 2017 (actual)
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 4 Jun 2018 (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.
This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. As many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. This research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.
Detailed description
Introduction This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. As many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. This research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.
Methodology It's a randomized controlled trial. Validated questionnaire (ITAS) was used to evaluate the psychological insulin barriers, video and Brochures were devolved as educational materials contain same contents and validated. Study conducted in King Abdulaziz city housing with total sample size of 126. They were divided into intervention group (video group) and controlled group (Brochure group). Both group filled the same questionnaire before the intervention. And then immediately after the intervention. Six weeks later, both groups filled the same questionnaire to measure the long-term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Printed material "brochure"This group received a printed material "brochure" as an educational material |
| intervention group | Experimental | Other: Audiovisual material "video"This group received an audiovisual material "video" as an educational material |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetic patients
- Age group from 30 to 70 years
- A1c = 8 mg/dL or above
- Both genders
Key exclusion criteria (3 listed)
- Pregnant women
- Blindness or profound vision loss
- Severe mental problems e.g. Psychosis
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 |
|---|---|---|
| Audiovisual material "video"an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy. | Other | intervention group |
| Printed material "brochure"an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray. | Other | control group |
Primary outcome
compare the impact of audiovisual educational materials verses printed educational materials
Time frame: 6 weeks
compare intervention versus control on type 2 diabetic patients' knowledge, attitude and practice towards insulin therapy by assessing the patients before, directly after and 6 weeks after the intervention using a validated questionnaire (ITAS) to evaluate the psychological insulin barriers, both intervention and control were devolved as educational materials contain same contents and validated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual material "video" and Printed material "brochure" in people with Diabetes Mellitus, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 Jun 2018. 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 Saudi Arabia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the impact of audiovisual educational materials verses printed educational materials (time frame: 6 weeks). 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 4 Jun 2018.