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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03544645
Other study ID # KingAbdullahIMRC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 16, 2017
Est. completion date March 28, 2018

Study information

Verified date May 2018
Source King Abdullah International Medical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date March 28, 2018
Est. primary completion date October 22, 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Audiovisual material "video"
an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.
Printed material "brochure"
an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.

Locations

Country Name City State
Saudi Arabia King Saud bin Abdulaziz University for Health Sciences Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 weeks
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