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

NCT04798937 | Completed

• 1 other identifier: 140221
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

type1diabetes

Keywords

adolescent; transition to adult care; type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hemoglobin glycated values

  Change from Baseline Hemoglobin glycated values at 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Motivational interviewing

Control group

NO INTERVENTION

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

Interventions

Motivational interviewing OTHER

a health education program based on motivational interviewing provided by a nurse

Intervention group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sousse: lead

Study Sites (1)

Farhat Hached University Hospital

Sousse, 4000, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 35568602 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Wood, Dr

  East Tennessee State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 15, 2021
• Study Start: January 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

TU (1)