Back to resultsThe Medicines Advice Service Evaluation
Primary Purpose
Type 2 Diabetes, Hyperlipidemias
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Medicines Advice Service
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Adherence
Eligibility Criteria
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
Sites / Locations
- UCL School of Pharmacy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient-centred tailored intervention
Control
Arm Description
Medicines Advice Service
Usual care
Outcomes
Primary Outcome Measures
Self-reported medication adherence
Secondary Outcome Measures
Prescription refill adherence
Self-reported medicine-related problems and concerns
Medicine-related problems and concerns will be assessed in a self-report questionnaire.
Beliefs about Medicines
Beliefs about medicines will be assessed in a self-report questionnaire using the Beliefs About Medicines Questionnaire (BMQ) (Horne et al. 1999).
HbA1c
Serum Cholesterol Levels
Full Information
NCT ID
NCT01864239
First Posted
April 29, 2013
Last Updated
May 26, 2015
Sponsor
University College, London
Collaborators
Pharmacy2U
1. Study Identification
Unique Protocol Identification Number
NCT01864239
Brief Title
The Medicines Advice Service Evaluation
Official Title
The Medicines Advice Service: A Randomised Controlled Trial of a Pharmacy-based Telephone Intervention to Support Patients Taking Medication for a Long-term Condition
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Pharmacy2U
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hyperlipidemias
Keywords
Adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
677 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient-centred tailored intervention
Arm Type
Experimental
Arm Description
Medicines Advice Service
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Medicines Advice Service
Intervention Description
The intervention consists of:
Telephone consultations with a pharmacist
Follow-up tailored written information
A medicine reminder chart
Primary Outcome Measure Information:
Title
Self-reported medication adherence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Prescription refill adherence
Time Frame
Baseline, 6 months and 12 months
Title
Self-reported medicine-related problems and concerns
Description
Medicine-related problems and concerns will be assessed in a self-report questionnaire.
Time Frame
Baseline, 3 months and 6 months
Title
Beliefs about Medicines
Description
Beliefs about medicines will be assessed in a self-report questionnaire using the Beliefs About Medicines Questionnaire (BMQ) (Horne et al. 1999).
Time Frame
Baseline, 3 months and 6 months
Title
HbA1c
Time Frame
Baseline and 6 months
Title
Serum Cholesterol Levels
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Barber
Organizational Affiliation
UCL School of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL School of Pharmacy
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26755665
Citation
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.
Results Reference
derived
Learn more about this trial
The Medicines Advice Service Evaluation
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