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

NCT ID: NCT03544645

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-16

Study Completion Date

2018-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention group

This group received an audiovisual material "video" as an educational material

Group Type EXPERIMENTAL

Audiovisual material "video"

Intervention Type OTHER

an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.

control group

This group received a printed material "brochure" as an educational material

Group Type ACTIVE_COMPARATOR

Printed material "brochure"

Intervention Type OTHER

an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Audiovisual material "video"

an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.

Intervention Type OTHER

Printed material "brochure"

an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammad Alsaif

bachelor degree in medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King Saud bin Abdulaziz University for Health Sciences

Riyadh, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KingAbdullahIMRC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.