Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/05/2006
Date assigned
31/08/2006
Last edited
03/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Ann Louise Kinmonth

ORCID ID

Contact details

Institute of Public Health
Robinson Way
Cambridge
CB2 2SR
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University of Cambridge (UK)

Sponsor details

16 Mill Lane
Cambridge
CB2 1SB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (ref: G73444)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes

03/02/2016: Plain English summary added.