Improving adherence to medication in stroke survivors (IAMSS): a randomised controlled trial: study protocol

BackgroundAdherence to therapies is a primary determinant of treatment success, yet the World Health Organisation estimate that only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. In a previous project, we found that 30% of stroke patients reported sub-optimal medication adherence, and this was associated with younger age, greater cognitive impairment, lower perceptions of medication benefits and higher specific concerns about medication. We now wish to pilot a brief intervention aimed at (a) helping patients establish a better medication-taking routine, and (b) eliciting and modifying any erroneous beliefs regarding their medication and their stroke.Methods/DesignThirty patients will be allocated to a brief intervention (2 sessions) and 30 to treatment as usual. The primary outcome will be adherence measured over 3 months using Medication Event Monitoring System (MEMS) pill containers which electronically record openings. Secondary outcomes will include self reported adherence and blood pressure.DiscussionThis study shall also assess uptake/attrition, feasibility, ease of understanding and acceptability of this complex intervention.Trial RegistrationCurrent Controlled Trials ISRCTN38274953

[1]  R. Schwarzer,et al.  Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. , 2006, British journal of health psychology.

[2]  P. Rothwell,et al.  Underestimation of the Early Risk of Recurrent Stroke: Evidence of the Need for a Standard Definition , 2004, Stroke.

[3]  Peter M. Rothwell,et al.  Stroke: Practical Management , 2008 .

[4]  J. Stephenson Noncompliance may cause half of antihypertensive drug "failures". , 1999, JAMA.

[5]  M. Prins,et al.  All that glisters is not gold: a comparison of electronic monitoring versus filled prescriptions – an observational study , 2006, BMC Health Services Research.

[6]  N. Albert Improving medication adherence in chronic cardiovascular disease. , 2008, Critical care nurse.

[7]  D. Alter,et al.  Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. , 2007, JAMA.

[8]  Keith J Petrie,et al.  Changing Illness Perceptions After Myocardial Infarction: An Early Intervention Randomized Controlled Trial , 2002, Psychosomatic medicine.

[9]  R. Califf,et al.  Long-Term Adherence to Evidence-Based Secondary Prevention Therapies in Coronary Artery Disease , 2006, Circulation.

[10]  P. Sheeran,et al.  Does changing behavioral intentions engender behavior change? A meta-analysis of the experimental evidence. , 2006, Psychological bulletin.

[11]  Kenneth H Mayer,et al.  A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. , 2009, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[12]  H. Diener,et al.  Adherence to Secondary Stroke Prevention Strategies – Results from the German Stroke Data Bank , 2003, Cerebrovascular Diseases.

[13]  Nick Barber,et al.  NHS service delivery and organisation R&D programme: concordance, adherence and compliance in medicine taking , 2006 .

[14]  Howard Leventhal,et al.  Illness cognition: Using common sense to understand treatment adherence and affect cognition interactions , 1992, Cognitive Therapy and Research.

[15]  Haynes Rb,et al.  Interventions for enhancing medication adherence (Review) , 2008 .

[16]  S. Brophy,et al.  Interventions for latent autoimmune diabetes (LADA) in adults. , 2011, The Cochrane database of systematic reviews.

[17]  G. Brennan,et al.  Are preventive drugs preventive enough? A study of patients' expectation of benefit from preventive drugs. , 2002, Clinical medicine.

[18]  T. Sappok,et al.  Compliance With Secondary Prevention of Ischemic Stroke: A Prospective Evaluation , 2001, Stroke.

[19]  R. Horne,et al.  Understanding different beliefs held by adherers, unintentional nonadherers, and intentional nonadherers: application of the Necessity-Concerns Framework. , 2008, Journal of psychosomatic research.

[20]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance , 2008, BMJ : British Medical Journal.

[21]  S. Erickson,et al.  The Concordance of Self-Report With Other Measures of Medication Adherence: A Summary of the Literature , 2004, Medical care.

[22]  S. De Geest,et al.  Adherence to Long-Term Therapies: Evidence for Action , 2003, European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology.

[23]  J. Weinman,et al.  The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication , 1999 .

[24]  P. Sheeran,et al.  Enhancing antiepileptic drug adherence: A randomized controlled trial , 2009, Epilepsy & Behavior.

[25]  Edgar Erdfelder,et al.  G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences , 2007, Behavior research methods.

[26]  A. Algra,et al.  Non–adherence to aspirin or oral anticoagulants in secondary prevention after ischaemic stroke , 2005, Journal of Neurology.