Roy Adaptation Model in People With Type 1 Diabetes | NCT05336929

Studies
Roy Adaptation Model in People With Type 1 Diabetes

NCT05336929

Sponsor

Balikesir University

Status

Completed

Last Update Posted

Apr 20, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes
Adolescent

Interventions

Roy adaptation model-based nursing education

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2016Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Mar 23, 2022

First Submission Date that Met QC Criteria

Apr 19, 2022

First Posted Date

Apr 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 20, 2022Actual

Name	Class
Uludag University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Roy adaptation model-based nursing education	Other		education arm (n=30)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Diabetes Knowledge Level	change from baseline in diabetes knowledge level on the 32 points diabetes knowledge level form at month 2	baseline and 2nd month

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sibel ergün, Assoc. Dr.	sibel.ergun@balikesir.edu.tr	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided