A Feasibility Study of the Impact on Blood Pressure Control of Supplementing Community Pharmacist Services With Structured Information on Blood Pressure and Its Treatment

December 4, 2017 updated by: Ejaz Cheema, University of Warwick

Hypertension is a major health problem, however its control is unsatisfactory. One of the reasons for such a high prevalence of this disease includes poor patient compliance to treatment. Approximately 30 % of newly diagnosed hypertensive patients stop taking their blood pressure medication by six months and 50% by 12 months.

The UK government is keen to encourage community pharmacists to play an active role in participation of services that can improve patient adherence to their medications. The New Medicines Service (NMS) and targeted Medicines Use Reviews (MUR) are established services which fund community pharmacists to review and explain medicine use to patients, with hypertension a common condition for which advice is given within these schemes. Within these schemes, advice is verbal and unstructured, with no specific written information provided on drugs or the disease being treated.

This study aims to determine whether structured information provided to participants verbally and in writing by community pharmacists about blood pressure and current medicine(s) within NMS and targeted MURs will be retained and will be associated with improved hypertension control. Participants will be recruited from people eligible for NMS and MURs and attending community pharmacies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1)18 or over 2) male or female 3) Have been started on any blood pressure medication

Exclusion Criteria:

1)Patients with English language problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual pharmacy care
Participants will not receive any structured written education on hypertension and its treatment
EXPERIMENTAL: usual pharmacy care plus structured information
Participants will be provided with validated verbal and written information on hypertension and its treatment, including information about class (es) of anti-hypertensive medication(s) used by each patient, and their common side-effects. The written material will be based on validated patient information leaflets from the British Heart Foundation and the Blood Pressure Association.
Other: Written and verbal patient education on hypertension and its treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systolic or diastolic blood pressure
Time Frame: 1 year (trial would be stopped at 26 weeks if it is not possible to recruit any further participants
Systolic and diastolic blood pressure will be measured and recorded in mm Hg using OMRON blood pressure monitors
1 year (trial would be stopped at 26 weeks if it is not possible to recruit any further participants

Secondary Outcome Measures

Outcome Measure
Time Frame
change in the knowledge of hypertension
Time Frame: one year(trial would be stopped at 26 weeks if it is not possible to recruit any further participants)
one year(trial would be stopped at 26 weeks if it is not possible to recruit any further participants)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warwick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (ESTIMATE)

September 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Warwick.123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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