NCT01939860

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

September 3, 2013

Last Update Submit

December 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in systolic or diastolic blood pressure

    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 Outcomes (1)

  • change in the knowledge of hypertension

    one year(trial would be stopped at 26 weeks if it is not possible to recruit any further participants)

Study Arms (2)

Usual pharmacy care

NO INTERVENTION

Participants will not receive any structured written education on hypertension and its treatment

usual pharmacy care plus structured information

EXPERIMENTAL

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

Interventions

usual pharmacy care plus structured information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • )Patients with English language problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

J P Goes chemist

Coventry, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 11, 2013

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations