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Impact of pharmaceutical care on the health outcomes in patients with systemic arterial hypertension and different care needs: a randomized controlled trial

Validation of patient selection indicators for insertion in a pharmaceutical care service focused on primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10j7gj5w
Enrollment
Unknown
Registered
2021-03-01
Start date
2012-01-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential (primary) hypertension

Interventions

Experimental Group (35 patients): Patients received pharmaceutical care (pharmacotherapy review, pharmacotherapeutic follow-up), health education, for a period of 12 months. Control Group (34 patient

Sponsors

Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Lead Sponsor
Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals attended by the Basic Health Unit pharmacy; age 18 years or older; diagnosis of Systemic Arterial Hypertension; use of at least one antihypertensive medication

Exclusion criteria

Exclusion criteria: Individuals who did not attend the first consultation; individuals who did not attend the monthly meetings for more than four consecutive months

Design outcomes

Primary

MeasureTime frame
Primary outcome: blood pressure parameter (mmHg). Considering the alfa value equal to 5 %, the Z value equal to 1.960 is obtained. From data in the literature, the sum of the initial and final standard deviations was considered equal to 30 mmHg, and a pressure reduction between 5-10 mmHg was considered to be clinically significant. ;Quality of life evaluation: Conducted through the application of the Mini-Questionnaire on Quality of Life in Hypertension. The questionnaire contains 17 questions, divided into two domains: Mental Status and Somatic Manifestations, and another question which is not included in either of the two domains, relating to general health perception. The patients answered the questions referring to the previous seven days. The higher the score obtained, the lower the patient's perception of quality of life.

Secondary

MeasureTime frame
Evaluation of adherence to medication treatment: The Morisky Modified Scale Test (MMS-6) was used, a brief and easy to understand instrument that aims to facilitate the identification and assessment of problems and barriers to adequate adherence. The form consists of a total of six questions, the answers of which are "yes" or "no", which monitor behavior when taking medications based on forgetfulness, carelessness or negligence, and interruption of the medication. In order to perform the data analysis, it was considered that the subject was 100 % correct when they answered "no" to the first four questions. Otherwise, the percentage of correct answers was calculated by dividing the number of responses that corresponded to the expected responses by six, and then multiplying by 100.;Knowledge regarding medication treatment: This was evaluated by the Medtake test. The original instrument was applied to each of the medications listed in the prescription and the knowledge regarding dose, indication, interaction with food, and scale of medication taken by the patient was assessed, with each correct answer corresponding to 25 % of knowledge regarding the medication. Thus, the knowledge related to each prescription medication received a score from 0 to 100 % and at the end, the prescription average was calculated.;Anthropometric data: Determinations of body weight (Kg) and height (m) were carried out on a Welmy® brand anthropometric scale. BMI was obtained by the ratio between weight (Kg) and the square of height (m). The abdominal circumference was measured at half the distance between the last rib and the iliac crest, between an inhalation and an exhalation of breath, while the hip measurement was performed around the region with the largest buttock protuberance. With these two values of body circumference, the waist to hip ratio (WHR) was calculated, dividing the first by the second. Body circumference measurements were made using an inextensible anthropometric Wisso® tap

Countries

Brazil

Contacts

Public ContactLeonardo Régis Pereira
lpereira@fcfrp.usp.br+55016-999923446

Outcome results

None listed

Source: REBEC (via WHO ICTRP)