HypertensionNCT02892929
Effect of Motivational Interview as a Strategy in the Reduction of Blood Pressure.
A study testing Motivational interviewing and Prescriptive Consultation in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This randomized clinical trial was designed to test the effectiveness of Motivational Interviewing in lowering blood pressure during six months follow-up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Motivational interviewing and Prescriptive Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Regular monitored in the hypertension outpatient clinic of HCPA for more than six months
Who cannot join
- Evident change in cognitive function, such as intellectual disability and dementia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Effect of Motivational Interview as a Strategy in the Reduction of Blood Pressure in Hypertensive Patients in Specialist Clinic- Randomized Clinical Trial.
This randomized clinical trial was designed to test the effectiveness of Motivational Interviewing in lowering blood pressure during six months follow-up.
Read the detailed 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 www.randomization.com. 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).
- Conditions
- Hypertension
- Being tested
- Motivational interviewing, Prescriptive Consultation
- Keywords
- Motivational Interviewing, Hypertension, Nursing, Randomized Controlled Trial, Life Style
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
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.
Prescriptive ConsultationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Prescriptive Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (7)
regular use of antihypertensive medications. (Medication assessment questionnaire-MAQ)
The study also included the Medication Assessment Questionnaire (MAQ), is a four-item self-report adherence scale developed by Morisky, Green, and Levine to assess medication adherence. This scale is based on the understanding that lack of adherence to drug therapy could occur in one or all of several ways: forgetting, carelessness, discontinuation of medication when feeling better, or initiation of drug use when feeling worse. This scale is scored from 0 to 4, with lower scores reflecting higher adherence.
Measured: 6 months
improvement of adherence to a low-sodium diet. (Dietary Sodium Restriction Questionnaire - DSRQ)
Scale that measures the adherence to a low-sodium diet.
Measured: 6 months
adherence to self-care behaviors. (Self-care of hypertension Inventory SC-HI)
The self-care evaluation was performed using the Self-care of hypertension Inventory (SC-HI), which has proven validity and reliability for this purpose in hypertensive patients. This scale, based on the Middle Range Theory of Self-Care in Chronic Illness, was developed for a group of U.S. investigators and has since been translated and adapted for use in Brazil. The SC-HI measures three dimensions: self-care maintenance, consisting of those behaviors aimed at maintaining and monitoring disease stability; self-care management, i.e., the patient's response to the signs and symptoms of hypertension; and self-care confidence, i.e., self-efficacy in managing the two other domains. The SC-HI has a standardized score between 0-100. Higher score meaning better self-care.
Measured: 6 months
Increase or maintenance of physical activity (International Physical Activity Questionnaire - IPAQ)
Questionnaire that mesures the physical activity.
Measured: 6 months
weight reduction
Was measured at the baseline and final evaluation.
Measured: 6 months
evaluation of changes in daytime sleepiness. (Epworth Sleepiness Scale)
Scale that measures the changes in daytime sleepiness.
Measured: 6 months
Cessation smoking. (Questionnaire with questions about the amount of cigarettes smoked per week )
That will be asked for the patients about the cessation smoking at baseline and at the final evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Graziella B Aliti, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892929
- Sponsor's protocol ID
- 16-0225
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2016
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31288854
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motivational Interview as a Strategy in the Reduction of Blood Pressure in Hypertensive Patients in Specialist Clinic- Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02892929
- Acronym / sponsor ID
- 16-0225
- Conditions
- Hypertension
- Keywords
- Motivational Interviewing, Hypertension, Nursing, Randomized Controlled Trial, Life Style
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial was designed to test the effectiveness of Motivational Interviewing in lowering blood pressure during six months follow-up.
Detailed 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 www.randomization.com. 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational interviewingThe 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. |
| Prescriptive Consultation | Active comparator | Behavioral: Prescriptive ConsultationPrescriptive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Regular monitored in the hypertension outpatient clinic of HCPA for more than six months
Key exclusion criteria (1 listed)
- Evident change in cognitive function, such as intellectual disability and dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingThe 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. | Behavioural | Motivational Interviewing |
| Prescriptive ConsultationPrescriptive 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. | Behavioural | Prescriptive Consultation |
Primary outcome
The reduction of at least 8 mmHg in systolic blood pressure and changes in diastolic blood pressure and mean blood pressure.
Time frame: 6 months
Measured by ABPM-24 h in the first and last protocol appointments
7 secondary outcomes
regular use of antihypertensive medications. (Medication assessment questionnaire-MAQ)
Time frame: 6 months
improvement of adherence to a low-sodium diet. (Dietary Sodium Restriction Questionnaire - DSRQ)
Time frame: 6 months
adherence to self-care behaviors. (Self-care of hypertension Inventory SC-HI)
Time frame: 6 months
Increase or maintenance of physical activity (International Physical Activity Questionnaire - IPAQ)
Time frame: 6 months
weight reduction
Time frame: 6 months
evaluation of changes in daytime sleepiness. (Epworth Sleepiness Scale)
Time frame: 6 months
Cessation smoking. (Questionnaire with questions about the amount of cigarettes smoked per week )
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 31288854Silveira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graziella B Aliti, PhD principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing and Prescriptive Consultation in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction of at least 8 mmHg in systolic blood pressure and changes in diastolic blood pressure and mean blood pressure. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.