- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01864239
The Medicines Advice Service Evaluation
May 26, 2015 updated by: University College, London
The Medicines Advice Service: A Randomised Controlled Trial of a Pharmacy-based Telephone Intervention to Support Patients Taking Medication for a Long-term Condition
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
677
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- UCL School of Pharmacy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient-centred tailored intervention
Medicines Advice Service
|
The intervention consists of:
|
No Intervention: Control
Usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported medication adherence
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prescription refill adherence
Time Frame: Baseline, 6 months and 12 months
|
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.
|
Baseline, 3 months and 6 months
|
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).
|
Baseline, 3 months and 6 months
|
HbA1c
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
|
Serum Cholesterol Levels
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nick Barber, UCL School of Pharmacy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
April 29, 2013
First Submitted That Met QC Criteria
May 23, 2013
First Posted (Estimate)
May 29, 2013
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12/0326
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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