Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson's disease (SMART-PD): study protocol for a randomised controlled trial (v7; 15 August 2014)

Rashmi Lakshminarayana, Duolao Wang, David Burn, K Ray Chaudhuri, Gemma Cummins, Clare Galtrey, Bruce Hellman, Suvankar Pal, Jon Stamford, Malcolm Steiger, Adrian Williams, SMART-PD Investigators, Rashmi Lakshminarayana, Duolao Wang, David Burn, K Ray Chaudhuri, Gemma Cummins, Clare Galtrey, Bruce Hellman, Suvankar Pal, Jon Stamford, Malcolm Steiger, Adrian Williams, SMART-PD Investigators

Abstract

Background: Nonadherence to treatment leads to suboptimal treatment outcomes and enormous costs to the economy. This is especially important in Parkinson's disease (PD). The progressive nature of the degenerative process, the complex treatment regimens and the high rates of comorbid conditions make treatment adherence in PD a challenge. Clinicians have limited face-to-face consultation time with PD patients, making it difficult to comprehensively address non-adherence. The rapid growth of digital technologies provides an opportunity to improve adherence and the quality of decision-making during consultation. The aim of this randomised controlled trial (RCT) is to evaluate the impact of using a smartphone and web applications to promote patient self-management as a tool to increase treatment adherence and working with the data collected to enhance the quality of clinical consultation.

Methods/design: A 4-month multicentre RCT with 222 patients will be conducted to compare use of a smartphone- and internet-enabled Parkinson's tracker smartphone app with treatment as usual for patients with PD and/or their carers. The study investigators will compare the two groups immediately after intervention. Seven centres across England (6) and Scotland (1) will be involved. The primary objective of this trial is to assess whether patients with PD who use the app show improved medication adherence compared to those receiving treatment as usual alone. The secondary objectives are to investigate whether patients who receive the app and those who receive treatment as usual differ in terms of quality of life, quality of clinical consultation, overall disease state and activities of daily living. We also aim to investigate the experience of those receiving the intervention by conducting qualitative interviews with a sample of participants and clinicians, which will be administered by independent researchers.

Trial registration: ISRCTN45824264 (registered 5 November 2013).

Figures

Figure 1
Figure 1
CONSORT flowchart for the SMART-PD trial. CONSORT, Consolidated Standards of Reporting Trials; OP, Outpatient; PTA, Parkinson’s tracker app; SMART-PD, Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson’s disease; TAU, Treatment as usual.
Figure 2
Figure 2
Screenshot of the self-tracking interface.
Figure 3
Figure 3
Screenshots of the finger-tapping test.
Figure 4
Figure 4
Screenshots of the number-size Stroop test.
Figure 5
Figure 5
Screenshot of a sample report generated by the Parkinson’s tracker app.

References

    1. Lewitt PA. Levodopa for the treatment of Parkinson’s disease. N Engl J Med. 2008;359:2468–2476. doi: 10.1056/NEJMct0800326.
    1. Van Den Eeden SK, Tanner CM, Bernstein AL, Fross RD, Leimpeter A, Bloch DA, Nelson LM. Incidence of Parkinson’s disease: variation by age, gender, and race/ethnicity. Am J Epidemiol. 2003;157:1015–1022. doi: 10.1093/aje/kwg068.
    1. Fahn S. Description of Parkinson’s disease as a clinical syndrome. Ann N Y Acad Sci. 2003;991:1–14. doi: 10.1111/j.1749-6632.2003.tb07458.x.
    1. Schrag A, Jahanshahi M, Quinn N. What contributes to quality of life in patients with Parkinson’s disease? J Neurol Neurosurg Psychiatry. 2000;69:308–312. doi: 10.1136/jnnp.69.3.308.
    1. Chaudhuri KR, Healy DG, Schapira AHV. Non-motor symptoms of Parkinson’s disease: diagnosis and management. Lancet Neurol. 2006;5:235–245. doi: 10.1016/S1474-4422(06)70373-8.
    1. Aarsland D, Andersen K, Larsen JP, Lolk A, Nielsen H, Kragh-Sørensen P. Risk of dementia in Parkinson’s disease: a community-based, prospective study. Neurology. 2001;56:730–733. doi: 10.1212/WNL.56.6.730.
    1. Aarsland D, Kurz MW. The epidemiology of dementia associated with Parkinson disease. J Neurol Sci. 2010;289:18–22. doi: 10.1016/j.jns.2009.08.034.
    1. Guttman M, Slaughter PM, Theriault ME, DeBoer DP, Naylor CD. Burden of parkinsonism: a population-based study. Mov Disord. 2003;18:313–319. doi: 10.1002/mds.10333.
    1. National Institute for Health and Care Excellence (NICE): Parkinson’s Disease: Diagnosis and Treatment in Primary and Secondary Care (NICE Clinical Guideline 35, issued June 2006). [] (accessed 29 August 2014),
    1. Schapira AHV, Emre M, Jenner P, Poewe W. Levodopa in the treatment of Parkinson’s disease. Eur J Neurol. 2009;16:982–989. doi: 10.1111/j.1468-1331.2009.02697.x.
    1. Schapira AH, Agid Y, Barone P, Jenner P, Lemke MR, Poewe W, Rascol O, Reichmann H, Tolosa E. Perspectives on recent advances in the understanding and treatment of Parkinson’s disease. Eur J Neurol. 2009;16:1090–1099. doi: 10.1111/j.1468-1331.2009.02793.x.
    1. 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;59:511–514. doi: 10.1111/j.1368-5031.2005.00426.x.
    1. World Health Organisation (WHO) Adherence to Long-Term Therapies: Evidence for Action. Geneva: WHO; 2003.
    1. Cutler DM, Everett W. Thinking outside the pillbox—medication adherence as a priority for health care reform. N Engl J Med. 2010;362:1553–1555. doi: 10.1056/NEJMp1002305.
    1. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487–497. doi: 10.1056/NEJMra050100.
    1. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23:1296–1310. doi: 10.1016/S0149-2918(01)80109-0.
    1. Zachary A, Marcum ZA, Sevick MA, Handler SM. Medication non-adherence: a diagnosable and treatable medical condition. JAMA. 2013;309:2105–2106. doi: 10.1001/jama.2013.4638.
    1. Haynes RB, McDonald H, Garg AX, Montague P. Cochrane Database Syst Rev. 2002. Interventions for helping patients to follow prescriptions for medications.
    1. Daley DJ, Myint PK, Gray RJ, Deane KH. Systematic review on factors associated with medication non-adherence in Parkinson’s disease. Parkinsonism Relat Disord. 2012;18:1053–1061. doi: 10.1016/j.parkreldis.2012.09.004.
    1. Leopold NA, Polansky M, Hurka MR. Drug adherence in Parkinson’s disease. Mov Disord. 2004;19:513–517. doi: 10.1002/mds.20041.
    1. Grosset KA, Bone I, Reid JL, Grosset D. Measuring therapy adherence in Parkinson’s disease: a comparison of methods. J Neurol Neurosurg Psychiatry. 2006;77:249–251. doi: 10.1136/jnnp.2005.064709.
    1. Turner BJ, Hecht FM. Improving on a coin toss to predict patient adherence to medications. Ann Intern Med. 2001;134:1004–1006. doi: 10.7326/0003-4819-134-10-200105150-00015.
    1. Zikmund-Fisher BJ, Couper MP, Singer E, Ubel PA, Ziniel S, Fowler FJ, Jr, Levin CA, Fagerlin A. Deficits and variations in patients’ experience with making 9 common medical decisions: the DECISIONS survey. Med Decis Making. 2010;30(5 Suppl):85S–95S. doi: 10.1177/0272989X10380466.
    1. Braddock CH, 3rd, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice: time to get back to basics. JAMA. 1999;282:2313–2320. doi: 10.1001/jama.282.24.2313.
    1. Edwards A, Elwyn G, Hood K, Atwell C, Robling M, Houston H, Kinnersley P, Russell I, the Study Steering Group Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Fam Pract. 2004;21:347–354. doi: 10.1093/fampra/cmh402.
    1. Légaré F, O’Connor AM, Graham ID, Wells GA, Tremblay S. Impact of the Ottawa Decision Support Framework on the agreement and the difference between patients’ and physicians’ decisional conflict. Med Decis Making. 2006;26:373–390. doi: 10.1177/0272989X06290492.
    1. Lökk J. Lack of information and access to advanced treatment for Parkinson’s disease patients. J Multidiscip Healthc. 2011;4:433–439. doi: 10.2147/JMDH.S27180.
    1. OFcom: Facts and Figures. [] (accessed 30 August 2014)
    1. OFcom . Communications Market Report. 2012.
    1. Krishna S, Boren SA, Balas AE. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009;15:231–240. doi: 10.1089/tmj.2008.0099.
    1. Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008;10:160–168. doi: 10.1089/dia.2008.0283.
    1. Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, Cartwright M, Rixon L, Knapp M, Henderson C, Rogers A, Fitzpatrick R, Hendy J, Newman S, the Whole System Demonstrator Evaluation Team Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. BMJ. 2012;344:e3874. doi: 10.1136/bmj.e3874.
    1. Mellone S, Tacconi C, Chiari L. Validity of a Smartphone-based instrumented Timed Up and Go. Gait Posture. 2012;36:163–165. doi: 10.1016/j.gaitpost.2012.02.006.
    1. Yamada M, Aoyama T, Okamoto K, Nagai K, Tanaka B, Takemura T. Using a Smartphone while walking: a measure of dual-tasking ability as a falls risk assessment tool. Age Ageing. 2011;40:516–519. doi: 10.1093/ageing/afr039.
    1. Daley DJ, Deane KH, Gray RJ, Worth PF, Clark AB, Sabanathan K, Pfeil E, Myint PK. 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. 2011;12:251. doi: 10.1186/1745-6215-12-251.
    1. Morisky DE, Green LW, Levin DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67–74. doi: 10.1097/00005650-198601000-00007.
    1. Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens. 2008;10:348–354. doi: 10.1111/j.1751-7176.2008.07572.x.
    1. 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. Qual Life Res. 1995;4:241–248. doi: 10.1007/BF02260863.
    1. van der Eijk M, Faber MJ, Ummels I, Aarts JW, Munneke M, Bloem BR. Patient-centeredness in PD care: development and validation of a patient experience questionnaire. Parkinsonism Relat Disord. 2012;18:1011–1016. doi: 10.1016/j.parkreldis.2012.05.017.
    1. Chaudhuri KR, Martinez‒Martin P, Brown RG, Sethi K, Stocchi F, Odin P, Ondo W, Abe K, MacPhee G, MacMohan D, Barone P, Rabey M, Forbes A, Breen K, Tluk S, Naidu Y, Olanow W, Williams AJ, Thomas S, Rye D, Tsuboi Y, Hand A, Schapira AHV. The metric properties of a novel non‒motor symptoms scale for Parkinson’s disease: results from an international pilot study. Movement Disord. 2007;22:1901–1911. doi: 10.1002/mds.21596.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. 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. Psychol Health. 1999;14:1–24. doi: 10.1080/08870449908407311.
    1. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:702–708. doi: 10.1136/bmj.328.7441.702.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Westin J, Dougherty M, Nyholm D, Groth T. A home environment test battery for status assessment in patients with advanced Parkinson’s disease. Comput Methods Programs Biomed. 2010;98:27–35. doi: 10.1016/j.cmpb.2009.08.001.
    1. Department of Health . Research Governance Framework for Health and Social Care. 2 2005.
    1. International Committee of Medical Journal Editors (ICMJE): Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated December 2013). [] (accessed 29 August 2014)

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