Motivational Interviewing in the Control of Arterial Hypertension and Type 2 Diabetes Mellitus
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
1 other identifier
interventional
189
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Apr 2018
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2018
CompletedFirst Submitted
Initial submission to the registry
October 7, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2021
CompletedMarch 16, 2021
March 1, 2021
1.2 years
October 7, 2018
March 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glycated hemoglobin
Mean difference between laboratory examination of glycated hemoglobin at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;
3 months after the end of two Nursing Consultation sessions as a intervention
Blood pressure
Mean difference of systolic and diastolic blood pressure at baseline and 3 months after the end of two Nursing Consultation sessions as a intervention;
3 months after the end of two Nursing Consultation sessions as a intervention
Study Arms (2)
Experimental: Motivational Interviewing
EXPERIMENTALINTERVENTION 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.
Nursing Consultation
ACTIVE COMPARATORCONTROL 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nossa Senhora da Conceição Hospital
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Related Publications (1)
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.
PMID: 33637368DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double Blind. The person responsible for randomizing and allocating research subjects, outcome assessors and those responsible for data analysis will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dokter Odontologist
Study Record Dates
First Submitted
October 7, 2018
First Posted
November 2, 2018
Study Start
April 11, 2018
Primary Completion
June 20, 2019
Study Completion
March 12, 2021
Last Updated
March 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share