NCT05926388

Brief Summary

The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

June 2, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

self-managementType 2 diabetes mellitusvideo-assisted instruction

Outcome Measures

Primary Outcomes (4)

  • Insulin Treatment Self-Management Scale 1 (Questionnaire)

    Patients' self-injection practices will be evaluated.

    Seven days after the training

  • Insulin Treatment Self-Management Scale 2 (Questionnaire)

    Patients' self-injection practices will be evaluated.

    Five weeks after the training

  • Insulin Administration Observation Form 1

    The scale identifies knowledge and skill levels of patients.

    Seven days after the training

  • Insulin Administration Observation Form 2

    The scale identifies knowledge and skill levels of patients.

    Five weeks after the training

Study Arms (1)

Video-assisted training group

EXPERIMENTAL

The researcher will train the patients with video-assisted on insulin therapy and administration.

Other: Video-assisted training

Interventions

Patients will be given training on insulin therapy and management using lecture, question-answer, video and demonstration methods.

Video-assisted training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • No hearing or communication problems
  • Self-injecting insulin

You may not qualify if:

  • Health care professionals
  • Chronic complications
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

izmir Bakircay University

Izmir, Menemen, 35160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2023

First Posted

July 3, 2023

Study Start

January 10, 2022

Primary Completion

May 10, 2022

Study Completion

August 10, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations