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NCT Number: NCT03729323

Motivational Interviewing in the Control of Arterial Hypertension and Type 2 Diabetes Mellitus

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nossa Senhora da Conceição Hospital

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

Motivational Interviewing

Behavioral

In Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be addressed based on the principles and techniques of the Motivational Interviewing.

Nursing Consultation

Behavioral

In Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be approached in a conventional manner, as routine of the services, based on the recommendations of the Primary Care Strategy Notebooks for the care of chronic conditions in DM2 and SAH and the SSC-GHC Institutional Protocol for SAH and DM2 Patient Care.

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 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;

  2. Blood pressure

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

Hospital Nossa Senhora da Conceicao

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Nov 2, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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