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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729323
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Systemic Arterial Hypertension Behavioral: Motivational interviewing Behavioral: Nursing Consultation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical-behavioral
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double Blind. The person responsible for randomizing and allocating research subjects, outcome assessors and those responsible for data analysis will be blinded.
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2018
Actual Primary Completion Date : June 20, 2019
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Motivational Interviewing
INTERVENTION GROUP: In this group, Diabetics and Hypertensives will attend two Nursing Consultation sessions based on the assumptions and techniques of Motivational Interviewing with a certified nurse with specific 20-hour theoretical and practical training for this approach style.
Behavioral: Motivational interviewing
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.

Active Comparator: Nursing Consultation
CONTROL GROUP: In this group, Diabetics and Hypertensives will attend two conventional nursing consultation sessions aimed at self-care, with a untrained nurse for the use of motivational interviewing, based on the recommendations of the Primary Care Strategy Notebooks for the care of chronic conditions in Diabetes Mellitus and Arterial Hypertension and the SSC-GHC Institutional Protocol for SAH and DM2 Patient Care.
Behavioral: Nursing Consultation
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 Outcome Measures :
  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;



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03729323


Locations
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Brazil
Nossa Senhora da Conceição Hospital
Porto Alegre, RS, Brazil, 91350-200
Sponsors and Collaborators
Hospital Nossa Senhora da Conceicao

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Responsible Party: Daniel Demétrio Faustino da Silva, Dokter Odontologist, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier: NCT03729323    
Other Study ID Numbers: Grupo Hospitalar Conceicao
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao:
Motivational Interviewing
Type 2 Diabetes Mellitus
Systemic Arterial Hypertension
Chronic Diseases
Self-care
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases