Plain English Summary
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar (glucose) level to become too high. Previous studies have shown that up to half of the tablets for type 2 diabetes may not be taken as prescribed. If we could help support patients in taking their medicines as prescribed, then the benefits of these drugs in reducing diabetes complications might be more widely realised. Previous studies to help patients with taking their medications regularly have used educational approaches or relied on use of prompts and reminders. We have been guided in our approach to this research by work from psychologists about how people might become motivated to take medicines regularly and how taking medicines can become a habit. The aim of this study is to measure the effectiveness of an intervention to support people with type 2 diabetes to take their medication.
Who can participate?
Patients aged 18 or over with type 2 diabetes, currently taking any oral glucose-lowering medication, whose control of their diabetes could benefit from improvement.
What does the study involve?
Participants are randomly allocated into two groups. In the intervention group patients receive additional support from their practice nurse to help them take their medicines more regularly; the other group receive standard treatment. We also collect blood samples and look at the relationships between taking tablets and levels of active drugs in the bloodstream.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
12 general practices from Oxfordshire, Buckinghamshire, Huntingdon, Suffolk and Essex (UK)
When is the study starting and how long is it expected to run for?
March 2006 to December 2008
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
Prof Ann Louise Kinmonth
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0500267/73444
Study information
Scientific title
Supported Adherence to Medication Study
Acronym
SAMS
Study hypothesis
The principal aim of the study is to measure the potential efficacy of an intervention to support hypoglycaemic medication among people with type 2 diabetes.
More details can be found at:
http://www.medschl.cam.ac.uk/gppcru/index.php?option=com_content&view=article&id=332:sams-supported-adherence-to-medication-study&catid=12:project-profiles&Itemid=59
Ethics approval
London Multicentre Research Ethics Committee, 30/03/2006, ref: 06/MRE02/3
Local approval was given by the following: Huntingdon Research Ethics Committee (REC), Oxfordshire REC C and A, Suffolk Local Research Ethics Committee
Study design
Ramdomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Type 2 diabetes
Intervention
Two stage randomisation trial. Initially a 1:1 randomisation to use of TrackCap measure of adherence; followed at eight weeks by a further randomisation 2:3 between standard care and use of motivational and volitional interventions to support medication adherence.
Standard care:
Participants will be asked to complete measures of belief, habit and intention to take medication regularly as prescribed.
Intervention group:
In addition to procedures for the standard care group, participants' beliefs about benefits and harms, views of important others and issues of control over taking their medication regularly, will be elicited. Participants will also be asked to make action plans for taking medication regularly as prescribed. Information for this group will include the advantages and disadvantages of taking medication regularly and advice about monitoring and reviewing action plans and maintaining motivation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The proportion of days on which the prescribed doses of main hypoglycaemic medication was correctly taken will be measured with an electronic medication monitor (TrackCap).
Secondary outcome measures
Secondary outcomes include HbA1c and well-being. Serum drug levels, self-reported measures of medication adherence, and information from dispensing records will also be collected to complement the electronic measure.
Overall trial start date
01/03/2006
Overall trial end date
01/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Individuals with type two diabetes of at least three month duration
2. Diagnosed aged 18 years or above
3. Currently taking any oral glucose-lowering agent
4. HbA1c equal to or above 7.5%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Those deemed by their General Practitioner unable to give informed consent on the basis of documented memory impairment or psychological or psychiatric illness that would make participation inappropriate
2. Those for whom tight glycaemic control would be inappropriate
Recruitment start date
01/03/2006
Recruitment end date
01/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Public Health
Cambridge
CB2 2SR
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (ref: G73444)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
NHS Support for Science Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18405345
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22480341
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24573909
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24902481
Publication citations
-
Protocol
Farmer AJ, Prevost AT, Hardeman W, Craven A, Sutton S, Griffin SJ, Kinmonth AL, , Protocol for SAMS (Support and Advice for Medication Study): a randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication., BMC Fam Pract, 2008, 9, 20, doi: 10.1186/1471-2296-9-20.
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Results
Farmer A, Hardeman W, Hughes D, Prevost AT, Kim Y, Craven A, Oke J, Boase S, Selwood M, Kellar I, Graffy J, Griffin S, Sutton S, Kinmonth AL, An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes., BMC Fam Pract, 2012, 13, 30, doi: 10.1186/1471-2296-13-30.
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Results
Sutton S, Kinmonth AL, Hardeman W, Hughes D, Boase S, Prevost AT, Kellar I, Graffy J, Griffin S, Farmer A, Does Electronic Monitoring Influence Adherence to Medication? Randomized Controlled Trial of Measurement Reactivity., Ann Behav Med, 2014, doi: 10.1007/s12160-014-9595-x.
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Results
Hardeman W, Lamming L, Kellar I, De Simoni A, Graffy J, Boase S, Sutton S, Farmer A, Kinmonth AL, Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study)., Implement Sci, 2014, 9, 70, doi: 10.1186/1748-5908-9-70.