Clinical Trials Logo

Clinical Trial Summary

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

Clinical Trial Description

The lead researcher is a cardiovascular nurse specialist with 10 years of experience in the care of patients with heart disease and she will be responsible for the application of the Motivational Interviewing (MI) technique in the appointments for the intervention group. She also participated in an intensive workshop about MI, which followed the recommendations of the Motivational Interviewing Network of Trainers19 in 2013, and more recently, in 2015 and 2016, she participated in two workshops on advanced MI techniques. During the study there will be monthly supervision with another specialist. The training and the supervision will be the responsibility of a PhD researcher in Psychiatry with consistent experience on Motivational Interviewing and training conducted in the United States with Miller and Rollnick.

The sample size was calculated with WinPepi 11.20 software. Sample size was estimated in 100 patients, 50 in the intervention group (IG) and 50 in the control group (CG), considering a difference of 8 mmHg between groups, standard deviation of 14 mmHg, 80% power, and alpha of 0.05. Adding 20% of losses the sample will have 120 patients, 60 for each group.

Hypertension outpatients of Hospital de Clínicas de Porto Alegre (HCPA) will be identified by the appointment book and invited to participate in the study through telephone calls. The first appointment will consist in obtaining the ICF and confirmation of eligibility. After ICF's signing and confirmation of eligibility, the patient will be randomized to one of the groups. Participants of both groups will attend monthly appointments: first appointment (D0), appointment of 30, 60, 90, 120, and 150 days, totaling six individual encounters, previously arranged in the Clinical Research Center (CRC) of HCPA, with an average duration of 30 minutes.

The randomization list was generated through the website The list will be in possession of a professional of the research group, however non-participant of this project. The allocation group of each patient will be hidden by opaque envelopes of identical appearance.

The researcher responsible for the application of the MI technique and the one responsible for the conduct of conventional appointments will be blinded to the outcomes of the study; therefore, the application of structured questionnaires, scales, and assessment of other variables of the study will be carried out by a researcher unblinded to the outcomes.

Statistical analysis:

Continuous variables will be expressed as mean standard deviation or median and interquartile range (25 and 75 percentile). Categorical variables will be expressed in absolute and percentage numbers. Chi-square will be used for associations between sociodemographic and clinical variables with the scores of the Self-Care Scale. The comparison of the quantitative variables between groups will be conducted by the Student's t-test or Mann-Whitney test, according to data's distribution. The values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the study, as well as the scores of the Self-Care Scale will be analyzed by the Generalized Estimating Equations (GEE) with Bonferroni correction. The pressure differences between both groups during the treatment will be analyzed by ANOVA test for repeated measurements. Analysis of Covariance will be conducted to adjust possible differences regarding the basal pressure. The 5% level of significance will be adopted and the data will be analyzed in the Statistical Package for the Social Sciences (SPSS) v.20 (Chicago, Illinois, USA). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02892929
Study type Interventional
Source Hospital de Clinicas de Porto Alegre
Contact Luana C Jacoby Silveira, Master
Phone 55 51 33588000
Status Recruiting
Phase N/A
Start date May 2016
Completion date January 2019

See also
  Status Clinical Trial Phase
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Recruiting NCT03632668 - Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072 Phase 1
Recruiting NCT02699645 - Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Phase 3
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT03660631 - Dissemination of the Cardiovascular Risk Service N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Recruiting NCT03266510 - Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function N/A
Recruiting NCT02796313 - Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities N/A
Completed NCT00508365 - Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT03503773 - The TARGET BP OFF-MED Trial Phase 2
Not yet recruiting NCT03678207 - The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients
Recruiting NCT03249753 - The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects Phase 1
Completed NCT03100812 - Asian American Partnerships in Research and Empowerment (AsPIRE) N/A
Recruiting NCT03099343 - Tailored Messaging to Reduce Sodium Intake N/A
Active, not recruiting NCT03288142 - The Smart Hypertension Control Study N/A
Completed NCT02147626 - Heart Health 4 Moms N/A
Not yet recruiting NCT03942276 - Effects of Different Exercises Interventions in Post-menopausal Women N/A
Not yet recruiting NCT03661177 - Reclaiming Indigenous Food and Health N/A
Not yet recruiting NCT03554382 - Efficient Self-management of Chronic Disease Using Health Information Technology - a Study on Hypertension N/A