Are Audiovisual Materials Superior to Printed Materials in Improving Awareness Among Type 2 Diabetic Patients? (SA)

May 21, 2018 updated by: Mohammad Alsaif, King Abdullah International Medical Research Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 14611
        • King Saud Bin Abdulaziz University for Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetic patients
  2. Age group from 30 to 70 years
  3. A1c = 8 mg/dL or above
  4. Both genders

Exclusion Criteria:

  1. Pregnant women
  2. Blindness or profound vision loss
  3. Severe mental problems e.g. Psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
This group received a printed material "brochure" as an educational material
Other: Printed material "brochure"
an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.
Experimental: intervention group
This group received an audiovisual material "video" as an educational material
Other: Audiovisual material "video"
an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah International Medical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2017

Primary Completion (Actual)

October 22, 2017

Study Completion (Actual)

March 28, 2018

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KingAbdullahIMRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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