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Roy Adaptation Model in People With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes, Adolescent

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Roy adaptation model-based nursing education
Sponsored by
Balikesir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    education arm (n=30)

    control arm (n=30)

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    HbA1c values
    change from baseline in HbA1c value at 3 months

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 23, 2022
    Last Updated
    April 19, 2022
    Sponsor
    Balikesir University
    Collaborators
    Uludag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05336929
    Brief Title
    Roy Adaptation Model in People With Type 1 Diabetes
    Official Title
    Effect of Roy Adaptation Model on Metabolic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Balikesir University
    Collaborators
    Uludag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes, Adolescent

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    education arm (n=30)
    Arm Type
    Experimental
    Arm Description
    Roy adaptation model-based training was given to the training arm.
    Arm Title
    control arm (n=30)
    Arm Type
    No Intervention
    Arm Description
    Roy adaptation model-based training not given to the training arm
    Intervention Type
    Other
    Intervention Name(s)
    Roy adaptation model-based nursing education
    Primary Outcome Measure Information:
    Title
    HbA1c values
    Description
    change from baseline in HbA1c value at 3 months
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    Diabetes Knowledge Level
    Description
    change from baseline in diabetes knowledge level on the 32 points diabetes knowledge level form at month 2
    Time Frame
    baseline and 2nd month
    Other Pre-specified Outcome Measures:
    Title
    Roy Adaptation Model Interview results
    Description
    Change of adaptation behavior to illness consisting of 27 questions in 2 months
    Time Frame
    baseline and 2nd month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    sibel ergün, Assoc. Dr.
    Organizational Affiliation
    sibel.ergun@balikesir.edu.tr
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Roy Adaptation Model in People With Type 1 Diabetes

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