The use of carer assisted adherence therapy for people with Parkinson's disease and their carers (CAAT-PARK): study protocol for a randomised controlled trial

Trials

Phyo K Myint²  Michael Pfeil¹  Kanagasabesan Sabanathan²  Allan B Clark¹  Paul F Worth²  Richard J Gray¹  Katherine HO Deane¹  David J Daley² 

[1] Faculty of Medicine and Health Sciences, University of East Anglia, Norwich Research Park, Norwich, Norfolk, NR4 7TJ, UK;Norfolk & Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich, Norfolk, NR4 7UY, UK

关键词: Adherence Therapy;    Adherence;    Medication;    Parkinson's disease;   

Others  :  1095760
DOI  :  10.1186/1745-6215-12-251

 received in 2011-09-26, accepted in 2011-11-28,  发布年份 2011

【 摘 要 】

Background

Pharmacological intervention is essential for managing the symptoms of Parkinson's disease. Adherence to medication regimens however is a major problem. Poor adherence leads to significant motor deterioration and inadequate symptom control. This results in poor quality of life. Whilst interventions to improve medication adherence have shown considerable benefit in other chronic conditions, the efficacy of such treatments in Parkinson's disease is less well researched. Many people with Parkinson's disease require substantial support from spouse/caregivers. This often extends to medication taking. Consequently, spouse/caregiver's support for timely medication management is paramount. We aim to investigate the benefit of a novel intervention, Carer Assisted Adherence Therapy, for improving medication adherence and quality of life in people with Parkinson's disease. Adherence therapy may help to optimise the efficacy of anti-parkinsonian agents, subsequently improving clinical outcomes.

Methods/Design

A parallel, randomised controlled trial will be conducted to investigate whether carer assisted adherence therapy is effective for improving medication adherence and quality of life. We aim to recruit 40 patient/carer pairs into each group. Participants will be randomly assigned by the Clinical Research Trials Unit at the University of East Anglia. Adherence therapy is a brief cognitive-behavioural approach aimed at facilitating a process of shared decision making. The central theory is that when patients make shared choices with a professional they are more likely to continue with those choices because they are personally owned and meaningful. Outcomes will be rates of adherence and quality of life, determined by the Morisky Medication Adherence Scale-4 and the Parkinson's disease Questionnaire-39 respectively. Assessments will take place post randomisation, immediately post intervention and 12-weeks post randomisation. Primary outcomes are adherence and quality of life at 12-week follow-up. Efficacy will be determined using intention-to-treat analysis. Independent samples t-tests will compare mean changes between groups from baseline to follow-up. Per protocol analysis will be conducted based on individuals with no major protocol deviation. Where imbalances in baseline characteristics are identified, an adjusted analysis will be performed using a regression model. Analysis will be masked to treatment allocation.

Trial Registration

ISRCTN: ISRCTN07830951

【 授权许可】

   
2011 Daley et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]NICE: The National Collaborating Centre for Chronic Conditions. Parkinson's Disease: National clinical guideline for diagnosis and management in primary and secondary care. London: Royal College of Physicians; 2006.
• [2]Schapira AHV, Obeso J: Timing of treatment initiation in Parkinson's disease: A need for reappraisal? Ann Neurol 2006, 59(3):559-562.
• [3]Albanese A: Diagnostic criteria for Parkinson's disease. Neurological Sciences 2003, 24(0):s23-s26.
• [4]Chaudhuri KR, Healy DG, Schapira AHV: Non-motor symptoms of Parkinson's disease: diagnosis and management. The Lancet Neurology 2006, 5(3):235-245.
• [5]Aarsland D, Zaccai J, Brayne C: A systematic review of prevalence studies of dementia in Parkinson's disease. Movement Disorders 2005, 20(10):1255-1263.
• [6]Aarsland D, Kurz MW: The Epidemiology of Dementia Associated with Parkinson's Disease. Brain Pathology 2010, 20(3):633-639.
• [7]Schapira AHV, Emre M, Jenner P, Poewe W: Levodopa in the treatment of Parkinson's disease. European Journal of Neurology 2009, 16(9):982-989.
• [8]Schapira AHV: Treatment Options in the Modern Management of Parkinson Disease. Arch Neurol 2007, 64(8):1083-1088.
• [9]Leoni O, Martignoni E, Cosentino M, Michielotto D, Calandrella D, Zangaglia R, Riboldazzi G, Oria C, Lecchini S, Nappi G, et al.: Drug prescribing patterns in Parkinson's disease: a pharmacoepidemiological survey in a cohort of ambulatory patients. Pharmacoepidemiology and Drug Safety 2002, 11(2):149-157.
• [10]Tan EK, Yeo AP, Tan V, Pavanni R, Wong MC: Prescribing pattern in Parkinson's disease: are cost and efficacy overriding factors? Int J Clin Pract 2005, 59(5):511-514.
• [11]Schapira A, Agid Y, Barone P, Jenner P, Lemke M, Poewe W, Rascol O, Reichmann H, Tolosa E: Perspectives on recent advances in the understanding and treatment of Parkinson's disease. European Journal of Neurology 2009, 16(10):1090-1099.
• [12]Holloway RG, Shoulson I, Fahn S, Kieburtz K, Lang A, Marek K, McDermott M, Seibyl J, Weiner W, Musch B, et al.: Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Arch Neurol 2004, 61(7):1044-1053.
• [13]Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE: A Five-Year Study of the Incidence of Dyskinesia in Patients with Early Parkinson's Disease Who Were Treated with Ropinirole or Levodopa. New England Journal of Medicine 2000, 342(20):1484-1491.
• [14]Bainbridge JL, Ruscin J: Challenges of Treatment Adherence in Older Patients with Parkinson's Disease. Drugs Aging 2009, 26(2):145-155.
• [15]Grosset KA, Reid JL, Grosset DG: Medicine-taking behavior: Implications of suboptimal compliance in Parkinson's disease. Movement Disorders 2005, 20(11):1397-1404.
• [16]Valldeoriola F, Coronell C, Pont C, Buongiorno MT, Cámara A, Gaig C, Compta Y, the members of the ASG: Socio-demographic and clinical factors influencing the adherence to treatment in Parkinson's disease: the ADHESON study. European Journal of Neurology 2010. no-no
• [17]Rigby D: Adherence assessment tools: Drugs dont work when they're not taken. The Australian Journal of Pharmacy 2007, 88:32-33.
• [18]Haynes RB, McDonald HP, Garg AX: Helping Patients Follow Prescribed Treatment. JAMA: The Journal of the American Medical Association 2002, 288(22):2880-2883.
• [19]NICE: Medicines Adherence: Involving patients in decisions about prescribed medications and supporting adherence. NICE Clinical Guidelines 76. Developed by the National Collaborative Centre for Primary Care 2009.
• [20]Osterberg L, Blaschke T: Adherence to Medication. New England Journal of Medicine 2005, 353(5):487-497.
• [21]Grosset D, European PDTCSG: Therapy adherence issues in Parkinson's disease. Journal of the Neurological Sciences 2010, 289(1-2):115-118.
• [22]Leopold NA, Polansky M, Hurka MR: Drug adherence in Parkinson's disease. Movement Disorders 2004, 19(5):513-517.
• [23]Grosset KA, Bone I, Grosset DG: Suboptimal medication adherence in Parkinson's disease. Movement Disorders 2005, 20(11):1502-1507.
• [24]Chaudhuri K, Taurah L, MacMahon D: PD LIFE: a prospective multi-centre longitudinal audit of quality of life in Parkinson's disease across the UK. J Neurol Neurosurg Psychiatry 2004, 75:516.
• [25]O'Sullivan SS, Evans AH, Lees AJ: Dopamine dysregulation syndrome: an overview of its epidemiology, mechanisms and management. CNS Drugs 2009, 23(2):157-170.
• [26]Péchevis M, Clarke CE, Vieregge P, Khoshnood B, Deschaseaux-Voinet C, Berdeaux G, Ziegler M, the Trial Study G: Effects of dyskinesias in Parkinson's disease on quality of life and health-related costs: a prospective European study. European Journal of Neurology 2005, 12(12):956-963.
• [27]A'Campo L, Spliethoff-Kamminga N, Macht M, Roos R: Caregiver education in Parkinson's disease: Formative evaluation of a standardized program in seven European countries. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care & Rehabilitation 2010, 19(1):55-64.
• [28]Cifu D, Carne W, Brown R, Pegg P, Ong J, Qutubuddin A, Baron M: Caregiver distress in parkinsonism. Journal of Rehabilitation Research and Development 2006, 43(4):499-508.
• [29]Kemp R, Kirov G, Everitt B, Haywood P, David A: Ramdomised Controlled Trial of Compliance Therapy: 18-month follow-up. British Journal of Psychiatry 1998, 172:413.
• [30]Gray R, White J, Schulz M, Abderhalden C: Enhancing medication adherence in people with schizophrenia: An international programme of research. International Journal of Mental Health Nursing 2010, 19(1):36-44.
• [31]Alhalaiqa F, Deane K, Nawafleh A, Clark A, Gray R: Adherence therapy for medication non-compliant patients with hypertension: a randomised controlled trial. Journal of Human Hypertension 2011.
• [32]Staring ABP, Van der Gaag M, Koopmans GT, Selten JP, Van Beveren JM, Hengevald MW, Loonen AJM, Mulder CL: Treatment adherence therapy in people with psychotic disorders: randomised controlled trial. The British Journal of Psychiatry 2010, 197:448-455.
• [33]Grosset D, Antonini A, Canesi M, Pezzoli G, Lee A, Shaw K, Cubo E, Martinez-Martin P, Rascol O, Negre-Pages L, et al.: Adherence to Antiparkinson Medication in a Multicenter European Study. Movement Disorders 2009, 24(6):826-832.
• [34]Evans AH, Lawrence AD, Potts J, Appel S, Lees AJ: Factors influencing susceptibility to compulsive dopaminergic drug use in Parkinson disease. Neurology 2005, 65(10):1570-1574.
• [35]Morisky D, Green LW, Levin DM: Concurrent and Predictive Validity of a Self-reported Measure of Medication Adherence. MEDICAL CARE 1986, 24(1):67-74.
• [36]Peto V, Jenkinson C, Fitzpatrick R, Greenhall R: The development and validation of a short measure of functioning and well being for individuals with Parkinson's disease. Quality of Life Research 1995, 4(3):241-248.
• [37]Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, et al.: Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Movement Disorders 2007, 22(1):41-47.
• [38]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 & Health 1999, 14(1):1-24.
• [39]Brooks R: EuroQol: the current state of play. Health policy 1996, 37(1):53-72.
• [40]Cousins R, Davies AD, Turnbull CJ, Playfer JR: Assessing caregiving distress: A conceptual analysis and a brief scale. British Journal of Clinical Psychology 2002, 41(4):387-403.
• [41]Elm JJ, Kamp C, Tilley BC, Guimaraes P, Fraser D, Deppen P, Brocht A, Weaver C, Bennett S, Investigators NN-P, et al.: Self-reported adherence versus pill count in Parkinson's disease: the NET-PD experience. Movement Disorders 2007, 22(6):822-827.
• [42]Peto V, Jenkinson C, Fitzpatrick R: PDQ-39: a review of the development, validation and application of a Parkinsopn's disease quality of life questionniare and its associated measures. Journal of Neurology 1998, 245(1):S10-S14.
• [43]Peto V, Jenkinson C, Fitzpatrick R: Determining minimally important differences for the PDQ 39 Parkinson's disease questionnaire. Age and Ageing 2001, 30(4):299.
• [44]Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, et al.: Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Scale presentation and clinimetric testing results. Movement Disorders 2008, 23(15):2129-2170.
• [45]Chou KL, Amick MM, Brandt J, Camicioli R, Frei K, Gitelman D, Goldman J, Growdon J, Hurtig HI, Levin B, et al.: A recommended scale for cognitive screening in clinical trials of Parkinson's disease. Movement Disorders 2010, 25(15):2501-2507.
• [46]Zigmond AS, Snaith RP: The Hospital Anxiety and Depression Scale. Acta Psychiatrica Scandinavica 1983, 67(6):361-370.
• [47]Bjelland I, Dahl AA, Haug TT, Neckelmann D: The validity of the Hospital Anxiety and Depression Scale: An updated literature review. Journal of psychosomatic research 2002, 52(2):69-77.
• [48]Gray R, Leese M, Bindman J, Becker T, Burti L, David A, Gournay K, Kikkert M, Koeter M, Puschner B, et al.: Adherence Therapy for people with Schizophrenia. European multicentre randomised controlled trial. British Journal of Psychiatry 2006, 189:508-514.
• [49]Gray R: Adherence Therapy: working together to improve health. A treatment manual for healthcare workers. [http:/ / eastanglia.academia.edu/ RichardGray/ Books/ 718181/ Adherence_therapy_manual] webciteUniversity of East Anglia 2011.
• [50]Braun V, Clarke V: Using thematic analysis in psychology. Qualitative Research in Psychology 2006, 3(2):77-101.
• [51]Alhalaiqa F, Deane KHO, Nawafleh AH, Clark A, Gray R: Adherence therapy for medication non-compliant patients with hypertension: a randomised controlled trial. J Hum Hypertens 2011.
• [52]Maneesakorn S, Robson D, Gournay K, Gray R: An RCT of adherence therapy for people with schizophrenia in Chiang Mai, Thailand. Journal of Clinical Nursing 2007, 16(0):1302-1312.
• [53]Staring ABP, Van der Gaag M, Koopmans GT, Selten JP, Van Beveren JM, Hengeveld MW, Loonen AJM, Mulder CL: Treatment adherence therapy in people with psychotic disorders: randomised controlled trial. The British Journal of Psychiatry 2010, 197(6):448-455.
• [54]Grosset KA, Grosset DG: Effect of educational intervention on medication timing in Parkinson's disease: a randomized controlled trial. BMC Neurology 2007, 7(1):20. BioMed Central Full Text
• [55]A'Campo LEI, Wekking EM, Spliethoff-Kamminga NGA, Le Cessie S, Roos RAC: The benefits of a standardized patient education program for patients with Parkinson's disease and their caregivers. Parkinsonism & related disorders 2010, 16(2):89-95.
• [56]Coons S, Sheahan S, Martin S, Hendricks J, Robbins C, Johnson J: Predictors of medication noncompliance in a sample of older adults. Clinical Therapeutics 1994, 16(1):110.
• [57]MacLaughlin EJ, Raehl CL, Treadway AK, Sterling TL, Zoller DP, Bond CA: Assessing Medication Adherence in the Elderly: Which Tools to Use in Clinical Practice? Drugs & Aging 2005, 22:231-255.
• [58]DiMatteo MR, Lepper HS, Croghan TW: Depression Is a Risk Factor for Noncompliance With Medical Treatment: Meta-analysis of the Effects of Anxiety and Depression on Patient Adherence. Arch Intern Med 2000, 160(14):2101-2107.
• [59]MacLaughlin EJ, Raehl CL, Treadway AK, Sterling TL, Zoller DP, Bond CA: Assessing Medication Adherence in the Elderly: Which tools to use in clinical practice? Drugs Aging 2005, 22(3):231-255.