Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04861727 |
| Other study ID # |
FARMRPA 01.2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 6, 2021 |
| Est. completion date |
August 30, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Federal University of Bahia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
