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

NCT ID: NCT04861727

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-06
• Study Completion Date: 2022-08-30

Brief 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 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.

Conditions

Systemic Arterial Hypertension; Pharmacotherapy; Pharmaceutical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

MRPA procedure

Intervention Type: OTHER

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 intervention

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: lead

Responsible Party

Márcio Galvão Guimarães de Oliveira

Clinical Professor of Pharmacy and Evidence-based Health Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcio GG Oliveira

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Locations

Farmácia Escola da UFBA, campus Anísio Teixeira

Vitória da Conquista, Estado de Bahia, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39503798 (View on PubMed)

Moreira 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.

Reference Type: DERIVED

PMID: 37365046 (View on PubMed)

Other Identifiers

FARMRPA 01.2021

Identifier Type: -

Identifier Source: org_study_id