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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906786
• Other study ID #: CEIm-CHUIMI-2017/974
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2019
• Source: Hospital Universitario Insular Gran Canaria
• Contact: Ana M Wägner
• Phone: +34 928453431
• Email: ana.wagner[@]ulpgc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario Materno-infantil de Las Palmas	Las Palmas De Gran Canaria	Las Palmas

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Insular Gran Canaria	Menarini Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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