Type 2 DiabetesNCT01864239
The Medicines Advice Service Evaluation
A study testing Medicines Advice Service in people with Type 2 Diabetes and Hyperlipidemias, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Hyperlipidemias
- What is being tested?
- Medicines Advice Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 677 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients prescribed medication(s) for at least one of the following conditions: type 2 diabetes, hyperlipidemia
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Hyperlipidemias
- Being tested
- Medicines Advice Service
- Keywords
- Adherence
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicines Advice ServiceOther
The intervention consists of:
- Telephone consultations with a pharmacist
- Follow-up tailored written information
- A medicine reminder chart
| Study group | Role | What they receive |
|---|---|---|
| Patient-centred tailored intervention | Experimental | Medicines Advice Service Receives: Other: Medicines Advice Service |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported medication adherence
Measured: 6 months
Secondary outcomes (5)
Prescription refill adherence
Measured: Baseline, 6 months and 12 months
Self-reported medicine-related problems and concerns
Medicine-related problems and concerns will be assessed in a self-report questionnaire.
Measured: Baseline, 3 months and 6 months
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).
Measured: Baseline, 3 months and 6 months
HbA1c
Measured: Baseline and 6 months
Serum Cholesterol Levels
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacy2U
- Responsible party
- Sponsor
- Investigators
- Nick Barber, Principal investigator, UCL School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864239
- Sponsor's protocol ID
- 12/0326
- Status last verified
- May 2015
- First submitted
- 29 Apr 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26755665
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01864239
- Acronym / sponsor ID
- 12/0326
- Conditions
- Type 2 Diabetes, Hyperlipidemias
- Keywords
- Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Pharmacy2U
- Study start
- Nov 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-centred tailored intervention | Experimental | Other: Medicines Advice ServiceMedicines Advice Service |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients prescribed medication(s) for at least one of the following conditions: type 2 diabetes, hyperlipidemia
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicines Advice ServiceThe intervention consists of: 1. Telephone consultations with a pharmacist 2. Follow-up tailored written information 3. A medicine reminder chart | Other | Patient-centred tailored intervention |
Primary outcome
Self-reported medication adherence
Time frame: 6 months
5 secondary outcomes
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
Beliefs about Medicines
Time frame: Baseline, 3 months and 6 months
HbA1c
Time frame: Baseline and 6 months
Serum Cholesterol Levels
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 26755665Lyons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Barber principal investigator
UCL School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicines Advice Service in people with Type 2 Diabetes and Hyperlipidemias, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported medication adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.