Use of Technology to Optimize Hypertension Treatment in Elderly People in Primary Care (MINOR)

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.

Study Overview

• Status: Completed
• Conditions: Pharmaceutical Care; Systemic Arterial Hypertension; Pharmacotherapy
• Intervention / Treatment: Other: MRPA procedure; Other: Pharmaceutical intervention

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 Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Vitória Da Conquista, Bahia, Brazil, 45028440
      • Farmácia Escola da UFBA, campus Anísio Teixeira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elderly with confirmation of a diagnosis of arterial hypertension (self-report, based on medical report or prescription)
• Using antihypertensive pharmacotherapy

Exclusion Criteria:

• Users who, for whatever reason, are unable to perform MRPA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group control; 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
Active Comparator: Intervention 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, 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.	Other: MRPA procedure; 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; Other: Pharmaceutical intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Blood Pressure in MRPA	Change from baseline systolic blood pressure in 45 days	45 days after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients identified with undertreatment	Patients who had blood pressure above target, needing to add doses or more antihypertensive drugs in pharmacotherapy	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	Baseline
Number of drug deprescribing suggestions made	Deprescribing suggestions made by pharmacists based on the average blood pressure value and clinical treatment protocols	Baseline
Number of pharmacotherapy adequacy suggestions accepted by the prescriber	Number of pharmacotherapy adequacy suggestions accepted by the prescriber	45 days after the intervention

Collaborators and Investigators

• Sponsor: Federal University of Bahia
• Investigators: Principal Investigator: Marcio GG Oliveira, Federal University of Bahia

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Systemic Arterial Hypertension;; Technology Applied to Health Care;; Pharmacotherapy;; Pharmaceutical Care.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: FARMRPA 01.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No