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Clinical Trials/NCT04798937
NCT04798937
Completed
Not Applicable

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

Université de Sousse1 site in 1 country66 target enrollmentJanuary 1, 2020
Conditionstype1diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
type1diabetes
Sponsor
Université de Sousse
Enrollment
66
Locations
1
Primary Endpoint
Transition Readiness Assessment Questionnaire (TRAQ) scores
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Université de Sousse
Responsible Party
Principal Investigator
Principal Investigator

Kawther Al ksir

Principal Investigator

Université de Sousse

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

Outcomes

Primary Outcomes

Transition Readiness Assessment Questionnaire (TRAQ) scores

Time Frame: Change from Baseline TRAQ score at 6 months

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 Outcomes

  • Hemoglobin glycated values(Change from Baseline Hemoglobin glycated values at 6 months)

Study Sites (1)

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