NCT05336929

Brief Summary

The study was conducted to determine the effect of Roy adaptation model-based education on disease compliance and metabolic control in adolescents with Type 1 diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

March 23, 2022

Last Update Submit

April 19, 2022

Conditions

Type 1 DiabetesAdolescent

Outcome Measures

Primary Outcomes (1)

  • HbA1c values

    change from baseline in HbA1c value at 3 months

    3 month

Secondary Outcomes (1)

  • Diabetes Knowledge Level

    baseline and 2nd month

Other Outcomes (1)

  • Roy Adaptation Model Interview results

    baseline and 2nd month

Study Arms (2)

education arm (n=30)

EXPERIMENTAL

Roy adaptation model-based training was given to the training arm.

Other: Roy adaptation model-based nursing education

control arm (n=30)

NO INTERVENTION

Roy adaptation model-based training not given to the training arm

Interventions

Roy adaptation model-based nursing educationOTHER
education arm (n=30)

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Having type 1 diabetes
  • Must be between the ages of 11-18
  • volunteering for research

You may not qualify if:

  • Presence of mental disability
  • To have received training on the content of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • sibel ergün, Assoc. Dr.

    sibel.ergun@balikesir.edu.tr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 20, 2022

Study Start

June 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share