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

NCT ID: NCT04798937

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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type1diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Motivational interviewing

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational interviewing

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sousse

OTHER

Sponsor Role lead

Responsible Party

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Kawther Al ksir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Wood, Dr

Role: STUDY_DIRECTOR

East Tennessee State University

Locations

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Farhat Hached University Hospital

Sousse, , Tunisia

Site Status

Countries

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Tunisia

References

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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.

Reference Type DERIVED
PMID: 35568602 (View on PubMed)

Other Identifiers

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140221

Identifier Type: -

Identifier Source: org_study_id

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