Clinical trial NCT03729323: Motivational Interviewing in the Control of Arterial Hypertension and Type 2 Diabetes Mellitus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Systemic Arterial Hypertension
Keywords: Motivational Interviewing
Type 2 Diabetes Mellitus
Systemic Arterial Hypertension
Chronic Diseases
Self-care
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical-behavioral
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 3 months after the end of two Nursing Consultation sessions as a intervention
measure: Blood pressure
timeFrame: 3 months after the end of two Nursing Consultation sessions as a intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Nossa Senhora da Conceição Hospital
state: RS
Study officials:
References:
citation: Steffen PLS, Mendonca CS, Meyer E, Faustino-Silva DD. Motivational Interviewing in the Management of Type 2 Diabetes Mellitus and Arterial Hypertension in Primary Health Care: An RCT. Am J Prev Med. 2021 May;60(5):e203-e212. doi: 10.1016/j.amepre.2020.12.015. Epub 2021 Feb 24.