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临床试验/NCT03906786
NCT03906786Unknown不适用

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

Hospital Universitario Insular Gran Canaria2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

motivacional interviewing group

Experimental

干预措施: motivational interviewing (Behavioral)

control group

No Intervention

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Insular Gran Canaria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosa María Sánchez Hernández

Clinical Doctor

Hospital Universitario Insular Gran Canaria

研究点 (2)

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