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临床试验/NCT03729323
NCT03729323已完成不适用

Nursing Consultation Based on Motivational Interviewing as a Strategy for the Control of Type 2 Diabetes Mellitus and Systemic Arterial Hypertension in Primary Healthcare: A RANDOMIZED CLINICAL TRIAL

Hospital Nossa Senhora da Conceicao2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2018年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

The goal of this study is to evaluate the effectiveness of Nursing Consultation based on the assumptions and techniques of Motivational Interviewing for the control of Type 2 diabetes mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare.

详细描述

Type 2 Diabetes Mellitus and Systemic Arterial Hypertension are major challenges to health systems worldwide, and control, adherence and promotion of self-care are the cornerstone of their management. In this context, an adequate therapist-patient relationship is the key to the success of these interventions in healthcare, and nurses have a recognized and outstanding role in improving adherence and care results in chronic diseases. Motivational Interviewing (MI) emerges as a skillful method of counseling that has proven to be effective in promoting changes in a wide variety of health-related behaviors, including hypertension and diabetes. Despite the increasing number of international studies in different health fields, the scientific production that assess the applicability of Motivational Interviewing to chronic diseases in the Brazilian setting is still modest. Recent studies suggest the need for further research involving the discussion and improvement of studies utilizing Motivational Interviewing in Brazil, as well as in other countries around the world, for better outlook on this area of investigation. Therefore, this study intends to contribute to this perspective and aims to investigate the effectiveness of this care strategy in individual Nursing consultations for people with DM2 and SAH who are being treated in three Primary Healthcare Clinics in the Northern Area of Porto Alegre - RS , Brazil, which are an integral part of the Grupo Hospitalar Conceição (GHC) Community Health Service (SSC). GHC treats patients from the Brazilian public health system exclusively, with universal and free access, and the SSC is comprised of 16 primary care and mental health services, caring for a population of 105,000 inhabitants in the northern and eastern areas of Porto Alegre, RS, Brazil. This will be a randomized, controlled, parallel and double-blind clinical trial to be conducted in the period from June to September, 2018.

MAIN GOAL: To evaluate the effectiveness of Nursing Consultation based on the assumptions and techniques of Motivational Interviewing in the control of Type 2 Diabetes Mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare.

SPECIFIC GOALS:

  • To characterize participants in terms of sociodemographic and economic profile, health history, and life habits;
  • To monitor and assess glycemic and pressure goals before and after intervention;
  • To estimate the prevalence of adherence to drug therapy and healthy life habits among participants before and after intervention;
  • To assess self-efficacy for participants' self-care before and after intervention.
  • To evaluate the Level of Importance and Confidence to change unhealthy behaviors among participants with DM2 and SAH, before and after intervention.

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)

盲法说明

Double Blind. The person responsible for randomizing and allocating research subjects, outcome assessors and those responsible for data analysis will be blinded.

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

  • Being 18 years old or older;
  • Having diagnosis of Type 2 Diabetes Mellitus and Systemic Arterial Hypertension.
  • Being registered in the programmatic action of the clinics under study under risk stratum 3;

排除标准

  • Being assessed at a risk stratum other than 3 at the time of the first meeting with the control and intervention group;
  • Showing a cognitive deficit or associated diseases compromising the patient's mental faculties

结局指标

主要结局

Blood pressure

时间窗: 3 months after the end of two Nursing Consultation sessions as a intervention

Mean difference of systolic and diastolic blood pressure at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;

Glycated hemoglobin

时间窗: 3 months after the end of two Nursing Consultation sessions as a intervention

Mean difference between laboratory examination of glycated hemoglobin at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Demétrio Faustino da Silva

Dokter Odontologist

Hospital Nossa Senhora da Conceicao

研究点 (2)

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