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

NCT03906786 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-04-08

No results posted yet for this study

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.

Conditions

  • Type1diabetes

Interventions

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.

Sponsors & Collaborators

  • Menarini Group

    collaborator INDUSTRY

  • Hospital Universitario Insular Gran Canaria

    lead OTHER

Principal Investigators

  • Ana M Wägner · Hospital Universitario Insular de Gran Canaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906786 on ClinicalTrials.gov