Systemic Arterial HypertensionMINORNCT04861727
Use of Technology to Optimize Hypertension Treatment in Elderly People in Primary Care
A study testing MRPA procedure and Pharmaceutical intervention in people with Systemic Arterial Hypertension and Pharmacotherapy, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The control of blood pressure (BP) in the elderly is influenced by several factors, among them, the measurement methodology. The measurement of BP in the office is prone to failures, so the use of technology associated with blood pressure measurements at home is an alternative to minimize failures and contribute to… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Arterial Hypertension, Pharmacotherapy, Pharmaceutical Care
- What is being tested?
- MRPA procedure and Pharmaceutical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jun 2021to 30 Aug 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly with confirmation of a diagnosis of arterial hypertension (self-report, based on medical report or prescription)
- Using antihypertensive pharmacotherapy
Who cannot join
- Users who, for whatever reason, are unable to perform MRPA.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Farmácia Escola da UFBA, campus Anísio Teixeira
Vitória da Conquista, Estado de Bahia, 45028440
About this study
The control of blood pressure (BP) in the elderly is influenced by several factors, among them, the measurement methodology. The measurement of BP in the office is prone to failures, so the use of technology associated with blood pressure measurements at home is an alternative to minimize failures and contribute to the optimization of treatment. The objective of this study will be to evaluate the adequacy of the treatment of Systemic Arterial Hypertension (SAH) in primary care using Home Blood Pressure Monitoring (MRPA). Method: Randomized clinical trial with hypertensive patients, aged 60 years or over, attended at the Family Pharmacy service inserted in the primary care of the municipal health network. The subjects who accept to participate in the study will be randomized to the intervention / control groups. submitted to MRPA, will undergo analysis of the pharmacotherapy prescribed for the treatment of SAH, collection of clinical data, which together will support the assessment of the adequacy of the treatment of hypertension. When inadequacies in pharmacotherapy are identified, suggestions for changes will be forwarded to the prescriber / professional or assistant health team, weighted by the pharmacist in agreement with the patient and according to the guidelines of the Brazilian Guideline on Hypertension. The outcomes: changes in treatment and blood pressure control in the intervention and control groups will be evaluated.
Read the detailed description
The study will be carried out at a municipal public pharmacy. The subjects will be users of the Family Pharmacy, aged 60 years or over, who seek the service to remove the drugs prescribed for the treatment of Systemic Arterial Hypertension. In order to calculate the sample for this study, the incidence of patients with Hypertension System who need treatment adjustments (under- or over-treatment) will be considered. It is expected that in the intervention group, MRPA indicates that 30% of patients will need to change their pharmacotherapy and, in the control group, using the office measure, 10%. For a two-tailed test with 80% power, 5% sampling error and 95% confidence level, the sample will be 160 users in the intervention group and 160 in the control group. Considering the pandemic of COVID-19 and the risk of infection during care in health services, whether from patients or health professionals from the health care network, the Family Pharmacy already adopts the screening for respiratory symptoms that identify suspected infection by Sars-Cov-2.To minimize the impact of selection and information bias, the following procedure will be used to select individuals: during attendance at the windows, each trained attendant will invite patients with eligibility criteria, when they accept, they will be inserted in the service schedule. The selection for control group and intervention group will take place by drawing from the list of scheduled people, with 3 participants being drawn for the Intervention Group, totaling 160 participants in each group. Data collection will only occur after signing the Informed Consent Form (ICF). The Control Group will be attended by Pharmacists and will have the data collected according to the standard collection instrument, will receive general guidance on blood pressure control and pharmacotherapy assessment. The Intervention Group, in addition to the control group procedures, will also perform the MRPA, the result of which will guide the pharmaceutical suggestions, when necessary, they also received a Letter of Referral to the Prescriber containing pharmaceutical suggestions for optimization of pharmacotherapy, considering the current clinical protocols. In the service, patients and companions will be instructed on preventive measures against Sars-coV-2 infection, in addition to performing hand hygiene with water and liquid soap or 70% alcohol gel. The office will undergo cleaning before and after use, as well as the material, in addition to adopting the time of 15 minutes between appointments, maintaining the ventilation of the room, following all the recommendations of the Ministry of Health. Pharmaceutical evaluation is already a routine of the service. For the purposes of this research, the procedures will be added to standardized instruments and routines to guarantee methodological quality and answer the questions of this research. The Data Collection Form (Appendix I) will be used, which includes the collection of data related to sociodemographic and clinical characteristics. In order to assess adherence, the Portuguese version of the Brief Medication Questionnaire (BMQ) will be used in two stages: during the initial evaluation, when the patient was included in the research and 45 days after the intervention.
The pharmaceutical suggestion procedure, for this research, is defined as forwarding a letter of suggestion to the prescriber, previously agreed with the patient, based on clinical evaluation, review of pharmacotherapy, adherence to treatment and result of the MRPA procedure. The definition of the conducts to be adopted will be based on the 8th Brazilian Guideline on Systemic Arterial Hypertension, and in a complementary way - as it is an elderly patient (60 years old or more) - by the Brazilian Consensus on Potential Medicines Inappropriate for the Elderly.
The data will be tabulated and analyzed using the SPPS® Statistic 25 software. The Kolmogorov-Sminorv test will be used to assess the data distribution. The paired T test will be used to assess the differences between BP measurements in the office and the MRPA mean. Continuous variables with normal distribution will be presented as means, standard deviations and Odds Ratio. Categorical variables will be presented as a proportion, using the Chi-square test. Values of p <0.05 will be considered significant.
To compare the proportion of patients with controlled and uncontrolled blood pressure, before and after application of the intervention, the chi-square test (χ2) will be used. Mean or median values of the MRPA Blood Pressure Mean will also be compared before and after the intervention / description and adherence before and after the MRPA procedure (baseline and at the end of the study) using the paired T test or Wilcoxon.
- Being tested
- MRPA procedure, Pharmaceutical intervention
- Keywords
- Systemic Arterial Hypertension;, Technology Applied to Health Care;, Pharmacotherapy;, Pharmaceutical Care.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRPA procedureOther
The patient will receive the device for BP measurement at home for a week and two daily measurements will be taken, one in the morning (between 6 and 10 am) and one in the afternoon / evening (between 6 pm and 10 pm), for seven days. At the end of the procedure, it is expected to record 14 measurements (representing a total of 42 in seven days), but it is considered feasible when at least 10 results are recorded, respecting the number of two measurements per day, in the periods oriented. Participants who do not reach the satisfactory number of measures or do not check between the times mentioned above, will be invited to repeat the procedure
Pharmaceutical interventionOther
The suggestion procedure, for this research, is defined as the pharmaceutical act of forwarding a letter of suggestion to the prescriber, previously agreed with the patient, based on clinical evaluation, review of pharmacotherapy, adherence to treatment and result of the MRPA procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group control | No intervention | will be attended by Pharmacists and will have the data collected according to the standard collection instrument, will make MRPA and will receive the report and general guidance on blood pressure control and pharmacotherapy assessment |
| Intervention group | Active comparator | will be attended by Pharmacists and will have the data collected according to the standard collection instrument, will receive general guidance on blood pressure control and pharmacotherapy assessment, will also do MRPA whose result will guide pharmaceutical suggestions, when necessary, they will also receive a Referral Letter to the Prescriber containing pharmaceutical suggestions for optimization of pharmacotherapy, considering the current clinical protocols. Receives: Other: MRPA procedure; Other: Pharmaceutical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Blood Pressure in MRPA
Change from baseline systolic blood pressure in 45 days
Measured: 45 days after the intervention
Secondary outcomes (4)
Proportion of patients identified with undertreatment
Patients who had blood pressure above target, needing to add doses or more antihypertensive drugs in pharmacotherapy
Measured: Baseline
Proportion of patients identified with overtreatment
Patients who had blood pressure below the target, needing to prescribe doses or withdraw antihypertensive drugs from pharmacotherapy
Measured: Baseline
Number of drug deprescribing suggestions made
Deprescribing suggestions made by pharmacists based on the average blood pressure value and clinical treatment protocols
Measured: Baseline
Number of pharmacotherapy adequacy suggestions accepted by the prescriber
Number of pharmacotherapy adequacy suggestions accepted by the prescriber
Measured: 45 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start6 Jun 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Model description
- The Control Group will be attended by Pharmacists and will have the data collected according to the standard collection instrument, will receive general guidance on blood pressure control and pharmacotherapy assessment. The Intervention Group, in addition to the control group procedures, will also perform the MRPA, the result of which will guide the pharmaceutical suggestions, when necessary, they also received a Letter of Referral to the Prescriber containing pharmaceutical suggestions for optimization of pharmacotherapy, considering the current clinical protocols.
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Márcio Galvão Guimarães de Oliveira, Federal University of Bahia
- Investigators
- Marcio GG Oliveira, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861727
- Sponsor's protocol ID
- FARMRPA 01.2021
- Acronym
- MINOR
- Status last verified
- Oct 2022
- First submitted
- 13 Apr 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva IM, Moreira PM, Santos AM, Castro PR, Aguiar EC, Oliveira MG. Desprescribing antihypertensives in older people in primary care: subgroup analysis of the MINOR randomised clinical trial. Int J Clin Pharm. 2025 Feb;47(1):53-59. doi: 10.1007/s11096-024-01805-y. Epub 2024 Nov 6.
PubMed 39503798Moreira PM, Aguiar EC, Castro PR, Almeida KC, Dourado JA, Paula SM, Melo MF, Santos PM, Oliveira MG. Optimizing Hypertension Treatment in Older Patients Through Home Blood Pressure Monitoring by Pharmacists in Primary Care: The MINOR Clinical Trial. Clin Ther. 2023 Oct;45(10):941-946. doi: 10.1016/j.clinthera.2023.06.007. Epub 2023 Jun 24.
PubMed 37365046
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Technology to Optimize Hypertension Treatment in Elderly People in Primary Care
- ClinicalTrials.gov ID
- NCT04861727
- Acronym / sponsor ID
- MINOR / FARMRPA 01.2021
- Keywords
- Systemic Arterial Hypertension;, Technology Applied to Health Care;, Pharmacotherapy;, Pharmaceutical Care.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 27 Apr 2021 (actual)
- 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.
The control of blood pressure (BP) in the elderly is influenced by several factors, among them, the measurement methodology. The measurement of BP in the office is prone to failures, so the use of technology associated with blood pressure measurements at home is an alternative to minimize failures and contribute to the optimization of treatment. The objective of this study will be to evaluate the adequacy of the treatment of Systemic Arterial Hypertension (SAH) in primary care using Home Blood Pressure Monitoring (MRPA). Method: Randomized clinical trial with hypertensive patients, aged 60 years or over, attended at the Family Pharmacy service inserted in the primary care of the municipal health network. The subjects who accept to participate in the study will be randomized to the intervention / control groups. submitted to MRPA, will undergo analysis of the pharmacotherapy prescribed for the treatment of SAH, collection of clinical data, which together will support the assessment of the adequacy of the treatment of hypertension. When inadequacies in pharmacotherapy are identified, suggestions for changes will be forwarded to the prescriber / professional or assistant health team, weighted by the pharmacist in agreement with the patient and according to the guidelines of the Brazilian Guideline on Hypertension. The outcomes: changes in treatment and blood pressure control in the intervention and control groups will be evaluated.
Detailed description
The study will be carried out at a municipal public pharmacy. The subjects will be users of the Family Pharmacy, aged 60 years or over, who seek the service to remove the drugs prescribed for the treatment of Systemic Arterial Hypertension. In order to calculate the sample for this study, the incidence of patients with Hypertension System who need treatment adjustments (under- or over-treatment) will be considered. It is expected that in the intervention group, MRPA indicates that 30% of patients will need to change their pharmacotherapy and, in the control group, using the office measure, 10%. For a two-tailed test with 80% power, 5% sampling error and 95% confidence level, the sample will be 160 users in the intervention group and 160 in the control group. Considering the pandemic of COVID-19 and the risk of infection during care in health services, whether from patients or health professionals from the health care network, the Family Pharmacy already adopts the screening for respiratory symptoms that identify suspected infection by Sars-Cov-2.To minimize the impact of selection and information bias, the following procedure will be used to select individuals: during attendance at the windows, each trained attendant will invite patients with eligibility criteria, when they accept, they will be inserted in the service schedule. The selection for control group and intervention group will take place by drawing from the list of scheduled people, with 3 participants being drawn for the Intervention Group, totaling 160 participants in each group. Data collection will only occur after signing the Informed Consent Form (ICF). The Control Group will be attended by Pharmacists and will have the data collected according to the standard collection instrument, will receive general guidance on blood pressure control and pharmacotherapy assessment. The Intervention Group, in addition to the control group procedures, will also perform the MRPA, the result of which will guide the pharmaceutical suggestions, when necessary, they also received a Letter of Referral to the Prescriber containing pharmaceutical suggestions for optimization of pharmacotherapy, considering the current clinical protocols. In the service, patients and companions will be instructed on preventive measures against Sars-coV-2 infection, in addition to performing hand hygiene with water and liquid soap or 70% alcohol gel. The office will undergo cleaning before and after use, as well as the material, in addition to adopting the time of 15 minutes between appointments, maintaining the ventilation of the room, following all the recommendations of the Ministry of Health. Pharmaceutical evaluation is already a routine of the service. For the purposes of this research, the procedures will be added to standardized instruments and routines to guarantee methodological quality and answer the questions of this research. The Data Collection Form (Appendix I) will be used, which includes the collection of data related to sociodemographic and clinical characteristics. In order to assess adherence, the Portuguese version of the Brief Medication Questionnaire (BMQ) will be used in two stages: during the initial evaluation, when the patient was included in the research and 45 days after the intervention.
The pharmaceutical suggestion procedure, for this research, is defined as forwarding a letter of suggestion to the prescriber, previously agreed with the patient, based on clinical evaluation, review of pharmacotherapy, adherence to treatment and result of the MRPA procedure. The definition of the conducts to be adopted will be based on the 8th Brazilian Guideline on Systemic Arterial Hypertension, and in a complementary way - as it is an elderly patient (60 years old or more) - by the Brazilian Consensus on Potential Medicines Inappropriate for the Elderly.
The data will be tabulated and analyzed using the SPPS® Statistic 25 software. The Kolmogorov-Sminorv test will be used to assess the data distribution. The paired T test will be used to assess the differences between BP measurements in the office and the MRPA mean. Continuous variables with normal distribution will be presented as means, standard deviations and Odds Ratio. Categorical variables will be presented as a proportion, using the Chi-square test. Values of p <0.05 will be considered significant.
To compare the proportion of patients with controlled and uncontrolled blood pressure, before and after application of the intervention, the chi-square test (χ2) will be used. Mean or median values of the MRPA Blood Pressure Mean will also be compared before and after the intervention / description and adherence before and after the MRPA procedure (baseline and at the end of the study) using the paired T test or Wilcoxon.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Control Group will be attended by Pharmacists and will have the data collected according to the standard collection instrument, will receive general guidance on blood pressure control and pharmacotherapy assessment. The Intervention Group, in addition to the control group procedures, will also perform the MRPA, the result of which will guide the pharmaceutical suggestions, when necessary, they also received a Letter of Referral to the Prescriber containing pharmaceutical suggestions for optimization of pharmacotherapy, considering the current clinical protocols.
| Arm | Type | Receives |
|---|---|---|
| Group control | No intervention | –will be attended by Pharmacists and will have the data collected according to the standard collection instrument, will make MRPA and will receive the report and general guidance on blood pressure control and pharmacotherapy assessment |
| Intervention group | Active comparator | Other: MRPA procedure, Other: Pharmaceutical interventionwill be attended by Pharmacists and will have the data collected according to the standard collection instrument, will receive general guidance on blood pressure control and pharmacotherapy assessment, will also do MRPA whose result will guide pharmaceutical suggestions, when necessary, they will also receive a Referral Letter to the Prescriber containing pharmaceutical suggestions for optimization of pharmacotherapy, considering the current clinical protocols. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly with confirmation of a diagnosis of arterial hypertension (self-report, based on medical report or prescription)
- Using antihypertensive pharmacotherapy
Key exclusion criteria (1 listed)
- Users who, for whatever reason, are unable to perform MRPA.
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 |
|---|---|---|
| MRPA procedureThe patient will receive the device for BP measurement at home for a week and two daily measurements will be taken, one in the morning (between 6 and 10 am) and one in the afternoon / evening (between 6 pm and 10 pm), for seven days. At the end of the procedure, it is expected to record 14 measurements (representing a total of 42 in seven days), but it is considered feasible when at least 10 results are recorded, respecting the number of two measurements per day, in the periods oriented. Participants who do not reach the satisfactory number of measures or do not check between the times mentioned above, will be invited to repeat the procedure | Other | Intervention group |
| Pharmaceutical interventionThe suggestion procedure, for this research, is defined as the pharmaceutical act of forwarding a letter of suggestion to the prescriber, previously agreed with the patient, based on clinical evaluation, review of pharmacotherapy, adherence to treatment and result of the MRPA procedure. | Other | Intervention group |
Primary outcome
Change in Mean Blood Pressure in MRPA
Time frame: 45 days after the intervention
Change from baseline systolic blood pressure in 45 days
4 secondary outcomes
Proportion of patients identified with undertreatment
Time frame: Baseline
Proportion of patients identified with overtreatment
Time frame: Baseline
Number of drug deprescribing suggestions made
Time frame: Baseline
Number of pharmacotherapy adequacy suggestions accepted by the prescriber
Time frame: 45 days after the intervention
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 5 Oct 2022.
- Derived from this study: PubMed 39503798Silva IM, Moreira PM, Santos AM, Castro PR, Aguiar EC, Oliveira MG. Desprescribing antihypertensives in older people in primary care: subgroup analysis of the MINOR randomised clinical trial. Int J Clin Pharm. 2025 Feb;47(1):53-59. doi: 10.1007/s11096-024-01805-y. Epub 2024 Nov 6.
- Derived from this study: PubMed 37365046Moreira PM, Aguiar EC, Castro PR, Almeida KC, Dourado JA, Paula SM, Melo MF, Santos PM, Oliveira MG. Optimizing Hypertension Treatment in Older Patients Through Home Blood Pressure Monitoring by Pharmacists in Primary Care: The MINOR Clinical Trial. Clin Ther. 2023 Oct;45(10):941-946. doi: 10.1016/j.clinthera.2023.06.007. Epub 2023 Jun 24.
- 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.
Marcio GG Oliveira principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRPA procedure and Pharmaceutical intervention in people with Systemic Arterial Hypertension and Pharmacotherapy, run by Federal University of Bahia 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 2 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 5 Oct 2022. 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?
Change in Mean Blood Pressure in MRPA (time frame: 45 days after the intervention). 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 NCT04861727, which also lists 2 linked publications.
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 5 Oct 2022.