The Medicines Advice Service Evaluation

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864239
• Other study ID #: 12/0326
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: May 26, 2015
• Start date: November 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperlipidemias
• Type 2 Diabetes

Intervention

Other:
• Medicines Advice Service
The intervention consists of: Telephone consultations with a pharmacist Follow-up tailored written information A medicine reminder chart

Locations

Country	Name	City	State
United Kingdom	UCL School of Pharmacy	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Pharmacy2U

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported medication adherence		6 months	No
Secondary	Prescription refill adherence		Baseline, 6 months and 12 months	No
Secondary	Self-reported medicine-related problems and concerns	Medicine-related problems and concerns will be assessed in a self-report questionnaire.	Baseline, 3 months and 6 months	No
Secondary	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).	Baseline, 3 months and 6 months	No
Secondary	HbA1c		Baseline and 6 months	No
Secondary	Serum Cholesterol Levels		Baseline and 6 months	No