NCT03544645

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
Last Updated

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

April 30, 2018

Last Update Submit

May 21, 2018

Conditions

Keywords

Diabetic Educationaudiovisual materialManual material

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Other: Printed material "brochure"

intervention group

EXPERIMENTAL

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

Other: Audiovisual material "video"

Interventions

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

intervention group

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

control group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant women
  • Blindness or profound vision loss
  • Severe mental problems e.g. Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud bin Abdulaziz University for Health Sciences

Riyadh, 14611, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
bachelor degree in medicine

Study Record Dates

First Submitted

April 30, 2018

First Posted

June 4, 2018

Study Start

July 16, 2017

Primary Completion

October 22, 2017

Study Completion

March 28, 2018

Last Updated

June 4, 2018

Record last verified: 2018-05

Locations