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Supported Adherence to Medication Study
ISRCTN ISRCTN30522359
DOI 10.1186/ISRCTN30522359
ClinicalTrials.gov identifier
EudraCT number
Public title Supported Adherence to Medication Study
Scientific title
Acronym SAMS
Serial number at source G0500267/73444
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 two 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
Lay summary Lay summary under review 3
Ethics approval Approved by the London Multicentre Research Ethics Committee on 30/03/2006 (reference number: 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
Countries of recruitment United Kingdom
Disease/condition/study domain Type two diabetes
Participants - 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%
Participants - 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
Anticipated start date 01/03/2006
Anticipated end date 01/12/2008
Status of trial Completed
Patient information material
Target number of participants 250
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding 1. Medical Research Council (UK) (ref: G73444)
2. NHS Support for Science Funding (UK)
Trial website
Publications 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
Contact name Prof  Ann Louise  Kinmonth
  Address Institute of Public Health
Robinson Way
  City/town Cambridge
  Zip/Postcode CB2 2SR
  Country United Kingdom
Sponsor University of Cambridge (UK)
  Address 16 Mill Lane
  City/town Cambridge
  Zip/Postcode CB2 1SB
  Country United Kingdom
Date applied 10/05/2006
Last edited 30/09/2014
Date ISRCTN assigned 31/08/2006
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