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

type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798937
• Other study ID #: 140221
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2021
• Source: Université de Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• type1diabetes

Intervention

Other:
• Motivational interviewing
a health education program based on motivational interviewing provided by a nurse

Locations

Country	Name	City	State
Tunisia	Farhat Hached University Hospital	Sousse

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sousse

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline TRAQ score at 6 months
Secondary	Hemoglobin glycated values	Hemoglobin glycated values	Change from Baseline Hemoglobin glycated values at 6 months