Condition category
Not Applicable
Date applied
03/02/2009
Date assigned
27/02/2009
Last edited
17/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Llyr Hughes

ORCID ID

Contact details

Community Pharmacist
Fferyllwyr Llyn Pharmacy
Siop Tan y Maes
Nefyn
Gwynedd
LL53 7PA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V2

Study information

Scientific title

Practice interventions for language sensitivity: a randomised controlled pilot study to inform the delivery of pharmaceutical services in Wales

Acronym

PILSen

Study hypothesis

The aim of this pilot study is to test the feasibility of a randomised controlled trial (RCT) to build the evidence base for effective healthcare communication in the delivery of pharmaceutical services in the bilingual setting. This will be achieved through the following objectives:
1. The effect of language appropriate consultations on patient outcomes will be measured through establishing a small randomised controlled trial (RCT) of language concordance in Medicines Use Reviews (MURs) conducted by two community pharmacists in North Wales
2. Corpus linguistic analysis techniques will be used to discern the processes and patterns of language use within the healthcare consultations

Ethics approval

North West Wales Local Research Ethics pending approval as of 03/02/2009

Study design

Feasibility patient preference randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Effective healthcare communication

Intervention

1. Welsh medium randomised Medicines Use Reviews
2. English medium randomised Medicines Use Reviews

Randomised according to the protocol. Patients who demonstrate a distinct language preference will be allocated to a Welsh or English medium preference MUR, according to their choice.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Medication Adherence Questionnaire to assess participants use of medication following a Medicines Use Reviews, measured at 1 day and 1 month.

Secondary outcome measures

1. Beliefs about Medicines Questionnaire
2. Satisfaction with Information about Medicines Scale
3. Language switching measures
4. Information on processes and patterns of language use
5. Process measures for assessing feasibility of larger trial

Measured at 1 day and 1 month.

Overall trial start date

01/03/2009

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Welsh speaking patients between 18 and 80 years of age, either sex
2. Patients who are referred for Medicines Use Reviews (MUR) at the specified community pharmacies
3. Patients who are able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Non-Welsh speaking patients
2. Patients below 18 and above 80 years of age
3. Patients who are not eligible for MURs at the specified community pharmacies
4. Patients who are unable to give informed consent

Recruitment start date

01/03/2009

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Fferyllwyr Llyn Pharmacy
Gwynedd
LL53 7PA
United Kingdom

Sponsor information

Organisation

Fferyllwyr Llyn Pharmacy (UK)

Sponsor details

c/o Mr Llyr Hughes
Community Pharmacist
Siop Tan y Maes
Nefyn
Gwynedd
LL53 7PA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.fferyllwyrllyn.co.uk/

Funders

Funder type

Government

Funder name

Welsh Assembly Government (UK) - Pharmacy Practice Development Scheme 2008-2009

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/05/2016: No publications found, verifying study status with principal investigator.