Effectiveness of Pharmaceutical Care on Primary Care Patients With Uncontrolled Hypertension (EPHACA)

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00807131
First received: October 31, 2008
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

This randomized clinical trial is a multicentre study conducted at 4 community-based pharmacies within the Brazilian public health service, which freely distributes standardized medicines. The group coordinator is located at the Universidade Federal do Rio Grande do Sul, a public university at Porto Alegre.


Condition Intervention
Hypertension
Behavioral: Patient follow-up
Behavioral: Counseling
Behavioral: Drug dispensing
Behavioral: pharmacy usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Pharmaceutical Care Program on Primary Care Patients With Uncontrolled Hypertension- A Brazilian Multicenter RCT

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adherence [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patient follow-up
Behavioral: Patient follow-up
Dader method, which was developed to provide pharmaceutical care, which consists of seven steps covering the evaluation of services, benefits of interventions, and identification of unexpected occurrences. Its objectives are to improve the patient quality of life.
Other Name: pharmaceutical care
Experimental: 2
Counseling
Behavioral: Counseling
The pharmacist proceeds the counseling when the patient comes to the pharmacy to take their medicines.
Other Name: pharmacist counseling
Experimental: 3
Drug dispensing
Behavioral: Drug dispensing
The pharmacist gives the drugs to the patient with the minimum of information necessary to guarantee a safe and effective drug intake.
Other Name: dispensing
Active Comparator: 4
pharmacy usual care
Behavioral: pharmacy usual care
The patient receives no information about their medicines in the pharmacy, unless he asks for it.
Other Name: usual care

Detailed Description:

Inclusion and exclusion criteria: Potential hypertensive subjects aged above 18 years and and continuously receiving their medicines from the pharmacy are going to be identified through administrative data sources. They must take at least hydrochlorothiazide, and have no modifications on their hypertensive drug prescription on the last 2 months. Patients who have a serious psychiatric disorder or a severe cognitive impairment, blindness, pregnancy or secondary hypertension will be excluded. To be considered eligible, the patients should have a mean systolic and diastolic blood pressure above 140 mmHg and 90 mmHg at the screening visit if there were no COM morbidities associated, and above 130 mmHg and 80 mmHg for high-risk patients, using the validated Omron Hern-705-CP upper arm automated monitor.

Strategy/process by which participants/centres will be selected and recruited to the trial: Research assistants will invite the potential subjects when they attend the pharmacy to take their medicines or via telephone calls. By this moment, they will confirm eligibility and proceed the BP measures. If eligible for the study, the participant will receive all the trial explanations and the written informed consent will be obtained.

Randomization: The random allocation will be stratified by gender through a computer-generated sequence, individually for each centre. To maintain cancel allocation status, opaque, numbered and sealed envelopes will be adopted.

Interventions: Three different kinds of pharmacist services will be adopted, with growing complexity levels: drug dispensing, counseling and patient follow-up for 8 months. These methods are part of the Brazilian pharmaceutical care agreement, developed on the year of 2002, and will be compared with the pharmacy usual care. Seven pharmacists and 12 students were in charge of the pharmaceutical care program. All of them were trained in a 20 hour-course. Procedures details are written in a manual of operations, willing to standardize the interventions.

Outcomes: The primary outcomes are the BP differences between the one measured at 8-month follow-up and the baseline BP and the adherence, determined by 2 ways: a) measurement of plasma levels of hydrochlorothiazide, measured at the beginning and at the end of the study; b) drugs refill along the 8-months prior the randomization and during the 8-months of the trial. The occurrence of drug-related problems will be evaluated as a secondary outcome.

Blindness: Open-label study. Sample size: The study was design to enroll 304 patients equally distributed within the 4 centers, to provide 80% of statistical power to reject the null hypothesis and an error of 5% (two-tailed). Sampling size was calculated on the basis of a standard deviation of 10 mmHg, powered to detect clinically meaningful differences in mean changes of 5 mmHg between usual care and the intervention arms at 8-months follow-up, considering a 20% of drop-outs. Analyses will be conducted on intention-to-treat basis.

• Statistics: To assess for any differences among the intervention groups, the baseline characteristics will be compared performing Pearson χ2 test for categorical variables and F tests for continuous variables, and Fisher Exact test or Kruskal-Wallis if necessary. For the primary outcomes, the same tests will be applied. Analysis of covariance will be used when necessary.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Potential hypertensive subjects aged above 18 years and and continuously receiving their medicines from the pharmacy are going to be identified through administrative data sources.
  • They must take at least hydrochlorothiazide, and have no modifications on their hypertensive drug prescription on the last 2 months.
  • To be considered eligible, the patients should have a mean systolic and diastolic blood pressure above 140 mmHg and 90 mmHg at the screening visit if there were no COM morbidities associated, and above 130 mmHg and 80 mmHg for high-risk patients.

Exclusion Criteria:

  • Patients who have a serious psychiatric disorder or a severe cognitive impairment, blindness, pregnancy or secondary hypertension will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807131

Locations
Brazil
Mauro Silveira de Castro
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Mauro Castro, PhD UFRGS
  More Information

No publications provided

Responsible Party: Mauro Silveira de Castro, UFRGS
ClinicalTrials.gov Identifier: NCT00807131     History of Changes
Other Study ID Numbers: 402736/2005-2
Study First Received: October 31, 2008
Last Updated: December 10, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
pharmacy care
hypertension
primary care
adherence

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014