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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01939860
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ejaz Cheema, University of Warwick

Tracking Information
First Submitted Date  ICMJE September 3, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Changes in systolic or diastolic blood pressure [ Time Frame: one year ]
Systolic and diastolic blood pressure will be measured and recorded in mm Hg using OMRON blood pressure monitors
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Changes in the number of New medicine services interventions completed by the pharmacists [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study of the Impact on Blood Pressure Control of Supplementing Community Pharmacist Services With Structured Information on Blood Pressure and Its Treatment
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Other: Written and verbal patient education on hypertension and its treatment
Study Arms  ICMJE
  • 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.
    Intervention: Other: Written and verbal patient education on hypertension and its treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
56
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
132
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939860
Other Study ID Numbers  ICMJE Warwick.123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ejaz Cheema, University of Warwick
Study Sponsor  ICMJE University of Warwick
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Warwick
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP