Clinical trial NCT03906786: Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.
Official title: Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type1diabetes
Keywords: self-care
motivational interviewing
doctor-pacient relationship
Lead sponsor: Hospital Universitario Insular Gran Canaria
Sponsor class: OTHER
Collaborators: name: Menarini Group
First posted: 2019-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Materno-infantil de Las Palmas
state: Las Palmas
Study officials:
affiliation: Hospital Universitario Insular de Gran Canaria
name: Ana M Wägner
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.