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Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes

Primary Purpose

type1diabetes

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Motivational interviewing
Sponsored by
Université de Sousse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for type1diabetes focused on measuring adolescent, transition to adult care, type 1 diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Being diagnosed with type 1 diabetes
  • Having an age between 13 and 18 years

Exclusion Criteria:

  • Having a neurological disability (epilepsy, autism)
  • Having a significant intellectual delay, which might have affected their ability to understand the content of the program

Sites / Locations

  • Farhat Hached University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Youth in this group received usual care, consisting of medical consultations, in combination with a health education program based on motivational interviewing provided by a nurse

Youth in this group received usual care only consisting of medical consultations

Outcomes

Primary Outcome Measures

Transition Readiness Assessment Questionnaire (TRAQ) scores
The TRAQ includes 20 items divided into five subscales: 1) Appointment keeping (7 questions; e.g., Do you call the doctor's office to make an appointment?) 2) Tracking health issues (4 questions; e.g., Do you keep a calendar or list of medical and other appointments?); 3) Managing medications (4 questions; e.g., Do you know what to do if you are having a bad reaction to your medications?); 4) Talking with healthcare providers (2 questions; e.g. Do you tell the doctor or nurse what you are feeling?); 5) Managing daily activities (3 questions; e.g. Do you help plan or prepare meals/food?). Each question has the same Liker response set from 1 to 5 using the Stages of Change Transtheoretical Model as a framework. A minimum score of ''1'' is assigned to the responses 'No, I don't know how' while a maximum score of '' 5 '' is assigned to responses labeled "Yes, I always do it when I need it." Higher scores mean better outcome.

Secondary Outcome Measures

Hemoglobin glycated values
Hemoglobin glycated values

Full Information

First Posted
March 7, 2021
Last Updated
March 12, 2021
Sponsor
Université de Sousse
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1. Study Identification

Unique Protocol Identification Number
NCT04798937
Brief Title
Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
Official Title
A RCT Using Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sousse

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
A brief, nurse-led educational intervention using motivational interviewing substantially improved general and disease-specific self-management skills in youth with type 1 diabetes.
Detailed Description
Introduction and Objectives: For youth with chronic health conditions, adolescence is associated with a deterioration of disease self-management and poor health outcomes. Effective interventions are needed to prepare youth for transition to adulthood and adult care. To prospectively assess the impact of an education program based on motivational interviewing on self-management skills and glycemic control in youth with Type 1 diabetes (T1D). Methods: After parental consent and youth assent, investigators prospectively randomized 66 adolescents 13-18 years old with type 1 diabetes to either usual care (regular medical consultation) or usual care supplemented by sessions with a nurse educator using a motivational interviewing (MI) approach and goal setting based on responses to the Transition Readiness Assessment Questionnaire (TRAQ) and T1D specific self-management skills. Primary outcomes were TRAQ change scores and HbA1c levels between baseline and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
type1diabetes
Keywords
adolescent, transition to adult care, type 1 diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
78 were screened and 66 youth were randomized to 2 groups of 33 each and followed for 6 months with data collection at time zero, 3 months and 6 months.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Youth in this group received usual care, consisting of medical consultations, in combination with a health education program based on motivational interviewing provided by a nurse
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Youth in this group received usual care only consisting of medical consultations
Intervention Type
Other
Intervention Name(s)
Motivational interviewing
Intervention Description
a health education program based on motivational interviewing provided by a nurse
Primary Outcome Measure Information:
Title
Transition Readiness Assessment Questionnaire (TRAQ) scores
Description
The TRAQ includes 20 items divided into five subscales: 1) Appointment keeping (7 questions; e.g., Do you call the doctor's office to make an appointment?) 2) Tracking health issues (4 questions; e.g., Do you keep a calendar or list of medical and other appointments?); 3) Managing medications (4 questions; e.g., Do you know what to do if you are having a bad reaction to your medications?); 4) Talking with healthcare providers (2 questions; e.g. Do you tell the doctor or nurse what you are feeling?); 5) Managing daily activities (3 questions; e.g. Do you help plan or prepare meals/food?). Each question has the same Liker response set from 1 to 5 using the Stages of Change Transtheoretical Model as a framework. A minimum score of ''1'' is assigned to the responses 'No, I don't know how' while a maximum score of '' 5 '' is assigned to responses labeled "Yes, I always do it when I need it." Higher scores mean better outcome.
Time Frame
Change from Baseline TRAQ score at 6 months
Secondary Outcome Measure Information:
Title
Hemoglobin glycated values
Description
Hemoglobin glycated values
Time Frame
Change from Baseline Hemoglobin glycated values at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with type 1 diabetes Having an age between 13 and 18 years Exclusion Criteria: Having a neurological disability (epilepsy, autism) Having a significant intellectual delay, which might have affected their ability to understand the content of the program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wood, Dr
Organizational Affiliation
East Tennessee State University
Official's Role
Study Director
Facility Information:
Facility Name
Farhat Hached University Hospital
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35568602
Citation
Al Ksir K, Wood DL, Hasni Y, Sahli J, Quinn M, Ghardallou M. Motivational interviewing to improve self-management in youth with type 1 diabetes: A randomized clinical trial. J Pediatr Nurs. 2022 Sep-Oct;66:e116-e121. doi: 10.1016/j.pedn.2022.05.001. Epub 2022 May 12.
Results Reference
derived

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Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes

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