Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.
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|ClinicalTrials.gov Identifier: NCT03906786|
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Type1diabetes||Behavioral: motivational interviewing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.|
|Actual Study Start Date :||March 7, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
|Experimental: motivacional interviewing group||
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.
|No Intervention: control group|
- Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906786
|Contact: Ana M Wägner||+34 email@example.com|
|Contact: Dácil Alvarado||+34 firstname.lastname@example.org|
|Complejo Hospitalario Universitario Materno-infantil de Las Palmas||Recruiting|
|Las Palmas De Gran Canaria, Las Palmas, Spain, 35016|
|Contact: Ana M Wägner, M.D. +34 928453431 email@example.com|
|Contact: Dácil Alvarado +34 928453431 firstname.lastname@example.org|
|Principal Investigator:||Ana M Wägner||Hospital Universitario Insular de Gran Canaria|