Roy Adaptation Model in People With Type 1 Diabetes

April 19, 2022 updated by: Gulsah Sunay Ertem, Balikesir University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria

  1. Presence of mental disability
  2. To have received training on the content of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: education arm (n=30)
Roy adaptation model-based training was given to the training arm.
Other: Roy adaptation model-based nursing education
NO_INTERVENTION: control arm (n=30)
Roy adaptation model-based training not given to the training arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c values
Time Frame: 3 month
change from baseline in HbA1c value at 3 months
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 2nd month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roy Adaptation Model Interview results
Time Frame: baseline and 2nd month
Change of adaptation behavior to illness consisting of 27 questions in 2 months
baseline and 2nd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Collaborators

Uludag University

Investigators

  • Principal Investigator: sibel ergün, Assoc. Dr., sibel.ergun@balikesir.edu.tr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (ACTUAL)

April 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Balıkesir University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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