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

NCT04861727 | Completed

• 1 other identifier: FARMRPA 01.2021
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Arterial Hypertension; Pharmacotherapy; Pharmaceutical Care

Keywords

Systemic Arterial Hypertension;; Technology Applied to Health Care;; Pharmacotherapy;; Pharmaceutical Care.

Outcome Measures

Primary Outcomes (1)

• Change in Mean Blood Pressure in MRPA

  Change from baseline systolic blood pressure in 45 days

  45 days after the intervention

Secondary Outcomes (4)

• Proportion of patients identified with undertreatment

  Baseline

• Proportion of patients identified with overtreatment

  Baseline

• Number of drug deprescribing suggestions made

  Baseline

• Number of pharmacotherapy adequacy suggestions accepted by the prescriber

  45 days after the intervention

Study Arms (2)

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.

Other: MRPA procedure; Other: Pharmaceutical intervention

Interventions

MRPA procedure 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

Intervention group

Pharmaceutical intervention 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.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Farmácia Escola da UFBA, campus Anísio Teixeira

Vitória da Conquista, Estado de Bahia, 45028440, Brazil

Location

Related Publications (2)

• 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.

  PMID: 39503798 DERIVED

• 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.

  PMID: 37365046 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marcio GG Oliveira

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Pharmacy and Evidence-based Health Care

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 27, 2021
• Study Start: June 6, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)