Type1diabetes
Conditions
Keywords
self-care, motivational interviewing, doctor-pacient relationship
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.
Interventions
BEHAVIORALmotivational 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
Menarini Group
Hospital Universitario Insular Gran Canaria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Contacts
Primary ContactAna M Wägner
Backup ContactDácil Alvarado
Outcome results
None listed