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The Medicines Advice Service Evaluation

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: NCT01864239
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Pharmacy2U
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
Self-reported medication adherence [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01864239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
  • Prescription refill adherence [ Time Frame: Baseline, 6 months and 12 months ]
  • Self-reported medicine-related problems and concerns [ Time Frame: Baseline, 3 months and 6 months ]
    Medicine-related problems and concerns will be assessed in a self-report questionnaire.
  • Beliefs about Medicines [ Time Frame: Baseline, 3 months and 6 months ]
    Beliefs about medicines will be assessed in a self-report questionnaire using the Beliefs About Medicines Questionnaire (BMQ) (Horne et al. 1999).
  • HbA1c [ Time Frame: Baseline and 6 months ]
  • Serum Cholesterol Levels [ Time Frame: Baseline and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Medicines Advice Service Evaluation
Official Title  ICMJE The Medicines Advice Service: A Randomised Controlled Trial of a Pharmacy-based Telephone Intervention to Support Patients Taking Medication for a Long-term Condition
Brief Summary The purpose of this study is to find out whether talking to a pharmacist on the telephone can help to support people taking medicine for a long-term condition.
Detailed Description Non-adherence to medication is common and although some interventions have shown promise in improving adherence, the findings are inconsistent. This randomised controlled trial aims to test the effectiveness of a pharmacy-based telephone intervention compared to usual care on medication adherence and health outcomes in patients taking medicines for a long-term condition.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Type 2 Diabetes
  • Hyperlipidemias
Intervention  ICMJE Other: Medicines Advice Service

The intervention consists of:

  1. Telephone consultations with a pharmacist
  2. Follow-up tailored written information
  3. A medicine reminder chart
Study Arms  ICMJE
  • Experimental: Patient-centred tailored intervention
    Medicines Advice Service
    Intervention: Other: Medicines Advice Service
  • No Intervention: Control
    Usual care
Publications * Lyons I, Barber N, Raynor DK, Wei L. The Medicines Advice Service Evaluation (MASE): a randomised controlled trial of a pharmacist-led telephone based intervention designed to improve medication adherence. BMJ Qual Saf. 2016 Oct;25(10):759-69. doi: 10.1136/bmjqs-2015-004670. Epub 2016 Jan 11.

*   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 26, 2015)
677
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2013)
600
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients prescribed medication(s) for at least one of the following conditions: type 2 diabetes, hyperlipidemia

Exclusion Criteria:

  • Patients living outside of England
  • Patients with no access to a telephone
  • Patients under the age of 18
  • Patients unable to give written informed consent
  • Patients on drugs for dementia
  • Patients showing signs of dementia or cognitive impairment in conversation
  • Patients with substantial hearing or sight impairment
  • Patients whose medications are ordered by a caregiver/family member
  • Patients with insufficient English to take part in the telephone intervention
  • Patients living with someone already taking part in the study
  • Patients newly prescribed a medication for the conditions listed in the inclusion criteria
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 NCT01864239
Other Study ID Numbers  ICMJE 12/0326
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Pharmacy2U
Investigators  ICMJE
Principal Investigator: Nick Barber UCL School of Pharmacy
PRS Account University College, London
Verification Date May 2015

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