Skip to main content
Top
Published in: BMC Neurology 1/2010

Open Access 01-12-2010 | Study protocol

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

Authors: Ronan O'Carroll, Martin Dennis, Marie Johnston, Cathie Sudlow

Published in: BMC Neurology | Issue 1/2010

Login to get access

Abstract

Background

Adherence 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/Design

Thirty 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.

Discussion

This study shall also assess uptake/attrition, feasibility, ease of understanding and acceptability of this complex intervention.

Trial Registration

Current Controlled Trials ISRCTN38274953
Appendix
Available only for authorised users
Literature
1.
go back to reference World Health Organisation: Adherence to long term therapies: evidence for action. 2003, Geneva: World Health Organisation World Health Organisation: Adherence to long term therapies: evidence for action. 2003, Geneva: World Health Organisation
2.
go back to reference Stephenson J: Noncompliance may cause half of antihypertensive drug "failures". Journal of the American Medical Association. 1999, 282: 313-314. 10.1001/jama.282.4.313.CrossRefPubMed Stephenson J: Noncompliance may cause half of antihypertensive drug "failures". Journal of the American Medical Association. 1999, 282: 313-314. 10.1001/jama.282.4.313.CrossRefPubMed
3.
go back to reference Newby LK, LaPointe NM, Chen AY, Kramer JM, Hammill BG, DeLong ER, Muhlbaier LH, Califf RM: Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease. Circulation. 2006, 113: 203-212. 10.1161/CIRCULATIONAHA.105.505636.CrossRefPubMed Newby LK, LaPointe NM, Chen AY, Kramer JM, Hammill BG, DeLong ER, Muhlbaier LH, Califf RM: Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease. Circulation. 2006, 113: 203-212. 10.1161/CIRCULATIONAHA.105.505636.CrossRefPubMed
4.
go back to reference Rasmussen JN, Chong A, Alter DA: Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. Journal of the American Medical Association. 2007, 297: 177-186. 10.1001/jama.297.2.177.CrossRefPubMed Rasmussen JN, Chong A, Alter DA: Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. Journal of the American Medical Association. 2007, 297: 177-186. 10.1001/jama.297.2.177.CrossRefPubMed
5.
go back to reference Albert NM: Improving medication adherence in chronic cardiovascular disease. Critical Care Nurse. 2008, 28: 54-64.PubMed Albert NM: Improving medication adherence in chronic cardiovascular disease. Critical Care Nurse. 2008, 28: 54-64.PubMed
6.
go back to reference Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X: Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews. 2008, CD000011-2 Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X: Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews. 2008, CD000011-2
7.
go back to reference Department of Health (UK): Reducing brain damage: faster access to better stroke care. 2005, London: The Stationery Office Department of Health (UK): Reducing brain damage: faster access to better stroke care. 2005, London: The Stationery Office
8.
go back to reference Warlow C, Sandercock P, Hankey G, van Gijn J, Dennis M, Bamford J, Wardlaw J, Sudlow C, Rinkel G, Rothwell P: Stroke: Practical Management. 2008, Oxford: Blackwell, 3CrossRef Warlow C, Sandercock P, Hankey G, van Gijn J, Dennis M, Bamford J, Wardlaw J, Sudlow C, Rinkel G, Rothwell P: Stroke: Practical Management. 2008, Oxford: Blackwell, 3CrossRef
9.
go back to reference SIGN: Management of patients with stroke or TIA: assessment, investigation, immediate management and secondary prevention. A national clinical guideline. 2008, Edinburgh: Scottish Intercollegiate Guidelines Network SIGN: Management of patients with stroke or TIA: assessment, investigation, immediate management and secondary prevention. A national clinical guideline. 2008, Edinburgh: Scottish Intercollegiate Guidelines Network
10.
go back to reference Hamann GF, Weimar C, Glahn J, Busse O, Diener HC: Adherence to secondary stroke prevention strategies - results from the German Stroke Data Bank. Cerebrovascular Disease. 2003, 15: 282-288. 10.1159/000069490.CrossRef Hamann GF, Weimar C, Glahn J, Busse O, Diener HC: Adherence to secondary stroke prevention strategies - results from the German Stroke Data Bank. Cerebrovascular Disease. 2003, 15: 282-288. 10.1159/000069490.CrossRef
11.
go back to reference Sappok T, Faulstich A, Stuckert E, Kruck H, Marx P, Koennecke HC: Compliance with secondary prevention of ischemic stroke: a prospective evaluation. Stroke; a journal of cerebral circulation. 2001, 32: 1884-1889.CrossRefPubMed Sappok T, Faulstich A, Stuckert E, Kruck H, Marx P, Koennecke HC: Compliance with secondary prevention of ischemic stroke: a prospective evaluation. Stroke; a journal of cerebral circulation. 2001, 32: 1884-1889.CrossRefPubMed
12.
go back to reference De Schryver EL, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A: Non-adherence to aspirin or oral anticoagulants in secondary prevention after ischaemic stroke. Journal of Neurology. 2005, 252: 1316-1321. 10.1007/s00415-005-0858-0.CrossRefPubMed De Schryver EL, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A: Non-adherence to aspirin or oral anticoagulants in secondary prevention after ischaemic stroke. Journal of Neurology. 2005, 252: 1316-1321. 10.1007/s00415-005-0858-0.CrossRefPubMed
13.
go back to reference Leventhal H, Diefenbach M, Leventhal EA: Illness cognition: using common sense to understand treatment adherence and affect cognition interactions. Cognitive Therapy and Research. 1992, 16: 143-163. 10.1007/BF01173486.CrossRef Leventhal H, Diefenbach M, Leventhal EA: Illness cognition: using common sense to understand treatment adherence and affect cognition interactions. Cognitive Therapy and Research. 1992, 16: 143-163. 10.1007/BF01173486.CrossRef
14.
go back to reference Clifford S, Barber N, Horne R: Understanding different beliefs held by adherers, unintentional nonadherers, and intentional nonadherers: application of the Necessity-Concerns Framework. Journal of Psychosomatic Research. 2008, 64: 41-46. 10.1016/j.jpsychores.2007.05.004.CrossRefPubMed Clifford S, Barber N, Horne R: Understanding different beliefs held by adherers, unintentional nonadherers, and intentional nonadherers: application of the Necessity-Concerns Framework. Journal of Psychosomatic Research. 2008, 64: 41-46. 10.1016/j.jpsychores.2007.05.004.CrossRefPubMed
15.
go back to reference O'Carroll RE, Hamilton B, Whittaker J, Dennis M, Johnston M, Sudlow C, Warlow C: Psychological factors which influence adherence to medication in stroke survivors. CSO Final Report Vol CZH/4/297. 2008 O'Carroll RE, Hamilton B, Whittaker J, Dennis M, Johnston M, Sudlow C, Warlow C: Psychological factors which influence adherence to medication in stroke survivors. CSO Final Report Vol CZH/4/297. 2008
16.
go back to reference Webb TL, Sheeran P: Does changing behavioral intentions engender behavior change? A meta-analysis of the experimental evidence. Psychological Bulletin. 2006, 132: 249-268. 10.1037/0033-2909.132.2.249.CrossRefPubMed Webb TL, Sheeran P: Does changing behavioral intentions engender behavior change? A meta-analysis of the experimental evidence. Psychological Bulletin. 2006, 132: 249-268. 10.1037/0033-2909.132.2.249.CrossRefPubMed
17.
go back to reference Brown I, Sheeran P, Reuber M: Randomized Controlled Trial of an Implementation Intention Intervention to Enhance Adherence with Antiepileptic Drug Treatment. Epilepsy & Behaviour. 2009, 16: 634-639. 10.1016/j.yebeh.2009.09.014.CrossRef Brown I, Sheeran P, Reuber M: Randomized Controlled Trial of an Implementation Intention Intervention to Enhance Adherence with Antiepileptic Drug Treatment. Epilepsy & Behaviour. 2009, 16: 634-639. 10.1016/j.yebeh.2009.09.014.CrossRef
18.
go back to reference Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. British Medical Journal. 2008, 337a: 1655-10.1136/bmj.a1655.CrossRef Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. British Medical Journal. 2008, 337a: 1655-10.1136/bmj.a1655.CrossRef
19.
go back to reference Coull AJ, Rothwell PM: Underestimation of the early risk of recurrent stroke: evidence of the need for a standard definition. Stroke; a journal of cerebral circulation. 2004, 35: 1925-1929.CrossRefPubMed Coull AJ, Rothwell PM: Underestimation of the early risk of recurrent stroke: evidence of the need for a standard definition. Stroke; a journal of cerebral circulation. 2004, 35: 1925-1929.CrossRefPubMed
20.
go back to reference Petrie KJ, Cameron LD, Ellis CJ, Buick D, Weinman J: Changing illness perceptions after myocardial infarction: an early intervention randomized controlled trial. Psychosomatic Medicine. 2002, 64: 580-586.CrossRefPubMed Petrie KJ, Cameron LD, Ellis CJ, Buick D, Weinman J: Changing illness perceptions after myocardial infarction: an early intervention randomized controlled trial. Psychosomatic Medicine. 2002, 64: 580-586.CrossRefPubMed
21.
go back to reference Horne R, Weinman J, Barber N, Elliot RA, Morgan M: Concordance, Adherence and Compliance in Medication Taking: a conceptual map and research priorities. 2006, London: Centre for NHS Service Delivery and Organisation NCSSDO Horne R, Weinman J, Barber N, Elliot RA, Morgan M: Concordance, Adherence and Compliance in Medication Taking: a conceptual map and research priorities. 2006, London: Centre for NHS Service Delivery and Organisation NCSSDO
22.
go back to reference Broadbent E, Petrie K, Weinman J: The Brief Illness Perception Questionnaire (BIPQ): Validity and Reliability. International Journal of Behavioral Medicine. 2004, 11: 278- Broadbent E, Petrie K, Weinman J: The Brief Illness Perception Questionnaire (BIPQ): Validity and Reliability. International Journal of Behavioral Medicine. 2004, 11: 278-
23.
go back to reference Horne R, Weinman J, Hankins M: The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and Health. 1999, 14: 1-24. 10.1080/08870449908407311.CrossRef Horne R, Weinman J, Hankins M: The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and Health. 1999, 14: 1-24. 10.1080/08870449908407311.CrossRef
24.
go back to reference Garber MC, Nau DP, Erickson SR, Aikens JE, Lawrence JB: The concordance of self-report with other measures of medication adherence: a summary of the literature. Medical Care. 2004, 42: 649-652. 10.1097/01.mlr.0000129496.05898.02.CrossRefPubMed Garber MC, Nau DP, Erickson SR, Aikens JE, Lawrence JB: The concordance of self-report with other measures of medication adherence: a summary of the literature. Medical Care. 2004, 42: 649-652. 10.1097/01.mlr.0000129496.05898.02.CrossRefPubMed
25.
go back to reference Sniehotta FF, Scholz U, Schwarzer R: Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. British Journal of Health Psychology. 2006, 11: 23-37. 10.1348/135910705X43804.CrossRefPubMed Sniehotta FF, Scholz U, Schwarzer R: Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. British Journal of Health Psychology. 2006, 11: 23-37. 10.1348/135910705X43804.CrossRefPubMed
26.
go back to reference Wetzels GE, Nelemans PJ, Schouten JS, van Wijk BL, Prins MH: All that glisters is not gold: a comparison of electronic monitoring versus filled prescriptions - an observational study. BMC Health Services Research. 2006, 6: 8-10.1186/1472-6963-6-8.CrossRefPubMedPubMedCentral Wetzels GE, Nelemans PJ, Schouten JS, van Wijk BL, Prins MH: All that glisters is not gold: a comparison of electronic monitoring versus filled prescriptions - an observational study. BMC Health Services Research. 2006, 6: 8-10.1186/1472-6963-6-8.CrossRefPubMedPubMedCentral
27.
go back to reference Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH: A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychology. 2009, 28: 1-10. 10.1037/a0012715.CrossRefPubMedPubMedCentral Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH: A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychology. 2009, 28: 1-10. 10.1037/a0012715.CrossRefPubMedPubMedCentral
28.
go back to reference Faul F, Erdfelder E, Lang A-G, Buchner A: G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods. 2007, 39: 175-91.CrossRefPubMed Faul F, Erdfelder E, Lang A-G, Buchner A: G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods. 2007, 39: 175-91.CrossRefPubMed
29.
go back to reference Trewby PN, Reddy AV, Trewby CS, Ashton VJ, Brennan G, Inglis J: Are preventive drugs preventive enough? A study of patients' expectation of benefit from preventive drugs. Clinical Medicine. 2002, 2: 527-533.CrossRefPubMed Trewby PN, Reddy AV, Trewby CS, Ashton VJ, Brennan G, Inglis J: Are preventive drugs preventive enough? A study of patients' expectation of benefit from preventive drugs. Clinical Medicine. 2002, 2: 527-533.CrossRefPubMed
Metadata
Title
Improving adherence to medication in stroke survivors (IAMSS): a randomised controlled trial: study protocol
Authors
Ronan O'Carroll
Martin Dennis
Marie Johnston
Cathie Sudlow
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2010
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/1471-2377-10-15

Other articles of this Issue 1/2010

BMC Neurology 1/2010 Go to the issue