NCT02892929

Brief Summary

This randomized clinical trial was designed to test the effectiveness of Motivational Interviewing in lowering blood pressure during six months follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

2.8 years

First QC Date

August 24, 2016

Last Update Submit

April 27, 2021

Conditions

Hypertension

Keywords

Motivational InterviewingHypertensionNursingRandomized Controlled TrialLife Style

Outcome Measures

Primary Outcomes (1)

  • The reduction of at least 8 mmHg in systolic blood pressure and changes in diastolic blood pressure and mean blood pressure.

    Measured by ABPM-24 h in the first and last protocol appointments

    6 months

Secondary Outcomes (7)

  • regular use of antihypertensive medications. (Medication assessment questionnaire-MAQ)

    6 months

  • improvement of adherence to a low-sodium diet. (Dietary Sodium Restriction Questionnaire - DSRQ)

    6 months

  • adherence to self-care behaviors. (Self-care of hypertension Inventory SC-HI)

    6 months

  • Increase or maintenance of physical activity (International Physical Activity Questionnaire - IPAQ)

    6 months

  • weight reduction

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

The motivational interview is a style of care that evokes the patient their motivations to make behavioral changes in the interests of their own health. It is a technique centered in patient to explore and resolve their ambivalence to modify unhealthy behavior.

Behavioral: Motivational interviewing

Prescriptive Consultation

ACTIVE COMPARATOR

Prescriptive consultation is the Methodology usual consultation. In this type of consultation the health professional who plans the action plan for the patient and determines how it will be the patient's lifestyle modification.

Behavioral: Prescriptive Consultation

Interventions

Motivational interviewingBEHAVIORAL

The approach combines the principles of patient-centered care with strategies to motivate the change. Since the first appointment, Motivational Interviewing techniques will be used aiming to work the ambivalence that is to seek treatment and modify the unhealthy behavior. From the second encounter until the appointment of 120 days, the participants will be subjected to individual encounters in which the MI approach will be applied focusing on behavior change.

Motivational Interviewing
Prescriptive ConsultationBEHAVIORAL

Prescriptive consultation is the Methodology usual consultation, in which the patient has little room to express themselves and the health professional who determines what and how the patient will hold the care of your health.

Prescriptive Consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Regular monitored in the hypertension outpatient clinic of HCPA for more than six months

You may not qualify if:

  • Evident change in cognitive function, such as intellectual disability and dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • Silveira LCJ, Aliti GB, Da Silva EM, Pimentel RP, Gus M, Rabelo-Silva ER. Effect of motivational interviewing in hypertensive patients (MIdNIgHT): study protocol for a randomized controlled trial. Trials. 2019 Jul 9;20(1):414. doi: 10.1186/s13063-019-3486-1.

    PMID: 31288854DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Graziella B Aliti, PhD

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 8, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)