Skip to main content
OpenTrials
Completed

NCT Number: NCT05336929

Roy Adaptation Model in People With Type 1 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Adolescent Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study was designed as a randomized controlled study. A total of 60 adolescents, training (n=30) and control (n=30) that meet the research criteria were divided by random method. Pre-training data of the groups were collected using the "Sociodemographic Form", "Diabetes Information Evaluation Form" and "Roy Adaptation Model Interview Form" and HbA1c values were recorded. The training group was trained on the Roy Adaptation Model by a month break, in two sessions. After the training, the adolescents in the training group were given a curvature booklet based on the Roy Adaptation model. The control group was not intervened. After the training, the diabetes Information Assessment Form and the Roy Adaptation Model Discussion Form have applied to both groups again and the values of HbA1c were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Roy adaptation model-based nursing education

Other

Primary outcomes

  1. HbA1c values

    Time frame: 3 month

    change from baseline in HbA1c value at 3 months

Secondary outcomes

  1. Diabetes Knowledge Level

    Time frame: baseline and 2nd month

    change from baseline in diabetes knowledge level on the 32 points diabetes knowledge level form at month 2

Other outcomes

  1. Roy Adaptation Model Interview results

    Time frame: baseline and 2nd month

    Change of adaptation behavior to illness consisting of 27 questions in 2 months

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Collaborators

  • Uludag University

Registry information

Official study title

Effect of Roy Adaptation Model on Metabolic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 20, 2022
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.