Telepharmacy on Patients With Arterial Hypertension

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. The main questions it aims to answer are: How effective is a pharmaceutical care protocol via teleconsultation on the clinical outcomes of elderly people with uncontrolled hypertension, when compared to in-person pharmaceutical care? How effective is a pharmaceutical care protocol via teleconsultation in adherence to the treatment of elderly people with hypertension, when compared to in-person pharmaceutical care? Participants will undergo four visits. Two visits will be for the application of instruments and measurement of clinical parameters to be carried out at the beginning and end of follow-up (visits 1 and 4). These will be carried out in a pharmacist's office at the pharmacy by previously trained pharmacists and pharmacy students. Visits 2 and 3 will be pharmaceutical consultations to be carried out in person and/or via telepharmacy. Researchers will compare pharmaceutical care via telepharmacy with in-person pharmaceutical care to see how effective these services are in controlling blood pressure in elderly patients with uncontrolled blood pressure.

Detailed Description
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Specific objectives Characterize the clinical and socio-demographic profile of the studied population. Compare the acceptance and clinical importance of interventions carried out by the pharmacist between the telepharmacy and in-person (control) groups. Evaluate patient adherence to medication treatment in the teleconsultation group and in person Evaluate patient satisfaction in the teleconsultation group and in-person consultation. Compare satisfaction between the telepharmacy and in-person (control) groups.

Official Title
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Evaluation of the Effectiveness of Telepharmacy on Clinical Outcomes of Patients With Arterial Hypertension: Celeste Randomized Clinical Trial

Conditions
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Hypertension

Intervention / Treatment
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* Other: Pharmaceutical care via telepharmacy and usual care
* Other: Pharmaceutical care in-person and usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients admitted to the service with a diagnosis of systemic arterial hypertension made by a physician based on a patient report, report or medical prescription. Patients who present uncontrolled blood pressure at the time of assessment based on the average of three measurements using a standardized protocol at the pharmacy will be included; Patients must have a cell phone and know how to use it; Patient not have previously received pharmaceutical care. Exclusion Criteria: Elderly people who are unable to use their cell phones due to cognitive impairments (Mini Mental State Examination (MMSE). Elderly person considered unable of using a telephone (Instrumental Activities of Daily Living) Elderly with controlled blood pressure according to home monitoring.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telepharmacy<br>Pharmaceutical care via telepharmacy | Other: Pharmaceutical care via telepharmacy and usual care<br>* Pharmacotherapeutic monitoring via telephone consultation<br>|
| Active Comparator: In-person<br>In-person pharmaceutical care | Other: Pharmaceutical care in-person and usual care<br>* Face-to-face pharmacotherapeutic monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Controlling blood pressure | Rate of patients reaching the blood pressure target for healthy elderly people: systolic pressure of 130-139 mmHg and diastolic pressure of 70-79 mmHg; and for frail elderly people: systolic pressure of 140-149 mmHg and diastolic pressure of 70-79mmHg according to guidelines from the Brazilian Society of Cardiology of 2020 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the treatment | Patients who score higher than eight points on the adherence scale will be considered to have high adherence, those who score between six and seven points will be classified as medium adherence and those who score less than 6 points will be classified as low adherence. | 3 months | 
| Patient satisfaction | The score will be calculated by the sum of the user's answers divided by the number of corresponding questions. Thus, the closer to 5, the greater the satisfaction with the service and the closer to 1, the greater the dissatisfaction. | 3 months | 
| Level of clinical significance of interventions | Clinical significance of the intervention as described by the DOCUMENT, which classifies interventions into four levels of clinical significance: low; light; moderate and high. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmaceutical care, telepharmacy, elderly patients