type1diabetesNCT04798937
Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
A study testing Motivational interviewing in people with type1diabetes, run by Université de Sousse at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- type1diabetes
- What is being tested?
- Motivational interviewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being diagnosed with type 1 diabetes
- Having an age between 13 and 18 years
Who cannot join
- Having a neurological disability (epilepsy, autism)
- Having a significant intellectual delay, which might have affected their ability to understand the content of the program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RCT Using Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
A brief, nurse-led educational intervention using motivational interviewing substantially improved general and disease-specific self-management skills in youth with type 1 diabetes.
Read the 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.
- Conditions
- type1diabetes
- Being tested
- Motivational interviewing
- Keywords
- adolescent, transition to adult care, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingOther
a health education program based on motivational interviewing provided by a nurse
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Motivational interviewing |
| Control group | No intervention | Youth in this group received usual care only consisting of medical consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline TRAQ score at 6 months
Secondary outcomes (1)
Hemoglobin glycated values
Hemoglobin glycated values
Measured: Change from Baseline Hemoglobin glycated values at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jan 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kawther Al ksir, Université de Sousse
- Investigators
- David Wood, Dr, Study director, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798937
- Sponsor's protocol ID
- 140221
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35568602
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT Using Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04798937
- Acronym / sponsor ID
- 140221
- Conditions
- type1diabetes
- Keywords
- adolescent, transition to adult care, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Université de SousseUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Motivational interviewingYouth 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 |
| Control group | No intervention | –Youth in this group received usual care only consisting of medical consultations |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Being diagnosed with type 1 diabetes
- Having an age between 13 and 18 years
Key exclusion criteria (2 listed)
- Having a neurological disability (epilepsy, autism)
- Having a significant intellectual delay, which might have affected their ability to understand the content of the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewinga health education program based on motivational interviewing provided by a nurse | Other | Intervention group |
Primary outcome
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.
1 secondary outcome
Hemoglobin glycated values
Time frame: Change from Baseline Hemoglobin glycated values at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Derived from this study: PubMed 35568602Al 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wood, Dr study director
East Tennessee State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with type1diabetes, run by Université de Sousse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition Readiness Assessment Questionnaire (TRAQ) scores (time frame: Change from Baseline TRAQ score at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.