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

Not Applicable

• Conditions: Type1diabetes
• Interventions: Behavioral: motivational interviewing

• Registration Number: NCT03906786
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-07
• Study First Submitted: 2019-03-25
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-05
• Last Update Submitted: 2019-04-05
• Study First Posted: 2019-04-08
• Last Update Posted: 2019-04-08
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
motivacional interviewing group	motivational interviewing	-

Primary Outcome Measures

Name	Time	Method
Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised	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

Trial Locations

Locations (1)

Complejo Hospitalario Universitario Materno-infantil de Las Palmas; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain