Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.
1 other identifier
interventional
60
1 country
1
Brief Summary
Type 1 diabetes requires a high level of involvement of patients to obtain good control by following complex therapeutic recommendations. Motivational Interviewing has proven to be effective in changing behaviors in sedentary people, with addictions and with obesity. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2019
CompletedFirst Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedApril 8, 2019
April 1, 2019
1.6 years
March 25, 2019
April 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised
The validated Spanish version of The Diabetes Self-Care Inventory-Revised version (SCI-R) (18) was used. This inventory consists of 15 items that refer to self-care behaviors in the treatment of diabetes, which are scored on a Likert scale ranging from (1 = "never" to 5 = "always"). The scores are converted with a formula and the responses range from 0-100; higher scores indicate higher levels of self-care
12 months
Study Arms (2)
motivacional interviewing group
EXPERIMENTALcontrol group
NO INTERVENTIONInterventions
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
You may qualify if:
- Patients with DM1 seen in outpatient clinics of Endocrinology and Nutrition with at least one year of evolution, HbA1c\> 8% and / or severe hypoglycemia in the previous 6 months
You may not qualify if:
- Gestion underway or scheduled for the next 9 months. Any circumstance that, in the opinion of the investigators, could interfere with the follow-up of the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitario Insular Gran Canarialead
- Menarini Groupcollaborator
Study Sites (1)
Complejo Hospitalario Universitario Materno-infantil de Las Palmas
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Related Publications (1)
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.
PMID: 33362714DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana M Wägner
Hospital Universitario Insular de Gran Canaria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Doctor
Study Record Dates
First Submitted
March 25, 2019
First Posted
April 8, 2019
Study Start
March 7, 2019
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
April 8, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Protocol and statistical plan: as son as posible Access to results. Upon publication
- Access Criteria
- Study protocol and statistical analysis plan will be published (draft in progress) Individual data/results (anonimized) will be available upon request
Anonimized results will be available upon request