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Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.

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ClinicalTrials.gov Identifier: NCT03906786
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Menarini Group
Information provided by (Responsible Party):
Rosa María Sánchez Hernández, Hospital Universitario Insular Gran Canaria

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.


Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: motivational interviewing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: motivacional interviewing group Behavioral: 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.

No Intervention: control group



Primary Outcome Measures :
  1. Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised [ Time Frame: 12 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906786


Contacts
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Contact: Ana M Wägner +34 928453431 ana.wagner@ulpgc.es
Contact: Dácil Alvarado +34 928453431 dacil.alvarado@ulpgc.es

Locations
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Spain
Complejo Hospitalario Universitario Materno-infantil de Las Palmas Recruiting
Las Palmas De Gran Canaria, Las Palmas, Spain, 35016
Contact: Ana M Wägner, M.D.    +34 928453431    ana.wagner@upgc.es   
Contact: Dácil Alvarado    +34 928453431    dacil.alvarado@ulpgc.es   
Sponsors and Collaborators
Hospital Universitario Insular Gran Canaria
Menarini Group
Investigators
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Principal Investigator: Ana M Wägner Hospital Universitario Insular de Gran Canaria

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Responsible Party: Rosa María Sánchez Hernández, Clinical Doctor, Hospital Universitario Insular Gran Canaria
ClinicalTrials.gov Identifier: NCT03906786     History of Changes
Other Study ID Numbers: CEIm-CHUIMI-2017/974
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonimized results will be available upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rosa María Sánchez Hernández, Hospital Universitario Insular Gran Canaria:
self-care
motivational interviewing
doctor-pacient relationship

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases