| Title: | Supported Adherence to Medication Study – to measure the potential efficacy of an intervention to support hypoglycaemic medication among people with type two diabetes. |
| Principal research question: | 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. |
| Background: | Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. |
| Methodology description: | Randomised controlled trial: The SAMS (Supported Adherence to Medication Study) trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation is carried out independently of trial co-ordination and practices using minimisation to adjust for selected confounders |
| Sample group description: | 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% |
| Outcome measure description: | 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 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. |
| UK ISRCT Number: | 30522359 |
| Project organisation | |
| Start date: | 1st January 2007 |
| End date: | 1st January 2010 |
| Contact person: | Mrs Sue Boase |
| Contact Details: | Primary Care Research Unit Institute of Public Health University Forvie Site, Robinson Way Cambridge Cambs CB2 0SR UK Telephone: (01223) 769276 Fax: 01223 762515 E-mail: sab72@medschl.cam.ac.uk |
| Collaborative: | The SAMS programme of research is a collaboration with the Department of Primary Health Care, University of Oxford. Contacts:
http://www.primarycare.ox.ac.uk/research/vascular/research/filessams
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| Funding information | |
| Funding Organisation: | Medical Research Council |
| Funding Reference: | G73444 |
| Funding Amount: | £195,248 |
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| Funding Organisation: | NHS R&D Support Funding |
| Funding Reference: | Thames Valley Primary Care Research Partnership |
| Funding Amount: | £99,225 |
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| References and Publications | |
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Supported Adherence to Medication Study – to measure the potential efficacy of an intervention to support hypoglycaemic medication among people with type two diabetes.
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