Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.
NCT ID: NCT03906786
Last Updated: 2019-04-08
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-03-07
2020-09-30
Brief Summary
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Our objective is to evaluate the impact of an intervention with Motivational Interviewing in patients with type 1 diabetes, through a randomized controlled clinical trial. At least sixty patients with type 1 diabetes will be included with HbA1c\> 8% that will be randomized with a ratio of 1: 1. In the intervention group, Motivational Interviewing will be applied in the routine clinical appointments with the Endocrinologist, while the control group will receive the same visits but in a traditional way.
The primary result will be self-care behaviors according to a validated questionnaire. Secondary outcomes include: HbA1c, number of hypoglycemia, motivation with self-care, self-efficacy, quality of life, compliance with patients' own objectives, lipid profile, weight and blood pressure.
The professionals will be trained in Motivational Interviewing with the objective of favoring the adherence to self-care, the motivation of the patient and improving doctor-patient relationship. They will also be evaluated through a specific questionnaire.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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motivacional interviewing group
motivational interviewing
The intervention will consist of 4 structured medical consultations in the form of a motivational interviewing compared to usual care, covering a 12-month intervention period. In both groups, the frequency of visits (c / 3 months) and the variables collected will be the same.
control group
No interventions assigned to this group
Interventions
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motivational interviewing
The intervention will consist of 4 structured medical consultations in the form of a motivational interviewing compared to usual care, covering a 12-month intervention period. In both groups, the frequency of visits (c / 3 months) and the variables collected will be the same.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Menarini Group
INDUSTRY
Hospital Universitario Insular Gran Canaria
OTHER
Responsible Party
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Rosa María Sánchez Hernández
Clinical Doctor
Principal Investigators
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Ana M Wägner
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Insular de Gran Canaria
Locations
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Complejo Hospitalario Universitario Materno-infantil de Las Palmas
Las Palmas de Gran Canaria, Las Palmas, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Alvarado-Martel D, Boronat M, Alberiche-Ruano MDP, Algara-Gonzalez MA, Ramallo-Farina Y, Wagner AM. Motivational Interviewing and Self-Care in Type 1 Diabetes: A Randomized Controlled Clinical Trial Study Protocol. Front Endocrinol (Lausanne). 2020 Dec 10;11:574312. doi: 10.3389/fendo.2020.574312. eCollection 2020.
Other Identifiers
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CEIm-CHUIMI-2017/974
Identifier Type: -
Identifier Source: org_study_id
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