Clinical and cost-effectiveness of ‘Live Well with Parkinson’s’ self-management intervention versus treatment as usual for improving quality of life for people with Parkinson’s: study protocol for a randomised controlled trial

De Rijk Md, Launer L, Berger K, Breteler M, Dartigues J, Baldereschi M, et al. Prevalence of Parkinson’s disease in Europe: a collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology. 2000;54(11 Suppl 5):S21-3.

PubMed  Google Scholar 

Dorsey ER, Constantinescu R, Thompson J, Biglan K, Holloway R, Kieburtz K, et al. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology. 2007;68(5):384–6.

Article  CAS  PubMed  Google Scholar 

Sveinbjornsdottir S. The clinical symptoms of Parkinson’s disease. J Neurochem. 2016;139:318–24.

Article  CAS  PubMed  Google Scholar 

Gerlach OH, Winogrodzka A, Weber WE. Clinical problems in the hospitalized Parkinson’s disease patient: systematic review. Mov Disord. 2011;26(2):197–208.

Article  PubMed  PubMed Central  Google Scholar 

Chaudhuri KR, Prieto-Jurcynska C, Naidu Y, Mitra T, Frades-Payo B, Tluk S, et al. The nondeclaration of nonmotor symptoms of Parkinson’s disease to health care professionals: an international study using the nonmotor symptoms questionnaire. Mov Disord. 2010;25(6):704–9.

Article  PubMed  Google Scholar 

Gallagher DA, Lees AJ, Schrag A. What are the most important nonmotor symptoms in patients with Parkinson’s disease and are we missing them? Mov Disord. 2010;25(15):2493–500.

Article  PubMed  Google Scholar 

Alderwick H, Dixon J. The NHS long term plan. BMJ. 2019;364:l84. https://doi.org/10.1136/bmj.l84.

Newman S, Steed L, Mulligan K. Self-management interventions for chronic illness. Lancet. 2004;364(9444):1523–37.

Article  PubMed  Google Scholar 

Richardson J, Loyola-Sanchez A, Sinclair S, Harris J, Letts L, MacIntyre NJ, et al. Self-management interventions for chronic disease: a systematic scoping review. Clin Rehabil. 2014;28(11):1067–77.

Article  PubMed  Google Scholar 

Parkinsons UK. Available from: https://www.parkinsons.org.uk/information-and-support.

Fereshtehnejad S-M. Strategies to maintain quality of life among people with Parkinson’s disease: what works? Neurodegenerative Dis Manag. 2016;6(5):399–415.

Article  Google Scholar 

Pigott JS, Kane EJ, Ambler G, Walters K, Schrag A. Systematic review and meta-analysis of clinical effectiveness of self-management interventions in Parkinson’s disease. BMC Geriatr. 2022;22(1):1–29.

Article  Google Scholar 

Tuijt R, Tan A, Armstrong M, Pigott J, Read J, Davies N, et al. Self-management components as experienced by people with Parkinson’s disease and their carers: a systematic review and synthesis of the qualitative literature. Parkinson’s Dis. 2020;2020:8857385.

Google Scholar 

Armstrong M, Tuijt R, Read J, Pigott J, Davies N, Manthorpe J, et al. Health care professionals’ perspectives on self-management for people with Parkinson’s: qualitative findings from a UK study. BMC Geriatr. 2021;21(1):1–11.

Article  Google Scholar 

Pearce G, Parke HL, Pinnock H, Epiphaniou E, Bourne CL, Sheikh A, et al. The PRISMS taxonomy of self-management support: derivation of a novel taxonomy and initial testing of its utility. J Health Serv Res Policy. 2016;21(2):73–82.

Article  PubMed  Google Scholar 

Corbin JM, Strauss A. Unending work and care: managing chronic illness at home. 1st edition. U.S: Jossey-Bass Inc.; 1988. p 384.

Michie S, Van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6(1):1–12.

Article  Google Scholar 

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;2013(346):e7586.

Article  Google Scholar 

Reichmann H. Clinical criteria for the diagnosis of Parkinson’s disease. Neurodegener Dis. 2010;7(5):284–90.

Article  PubMed  Google Scholar 

Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–9.

Article  PubMed  Google Scholar 

Pigott J, Kane EJ, Ambler G, Walters K, Schrag A. Systematic review and meta-analysis of clinical effectiveness of self-management interventions in Parkinson’s. 2021.

Book  Google Scholar 

Shah R, Read J, Davies N, Nimmons D, Pigott J, Schrag A, et al. People with Parkinson’s perspectives and experiences of self-management: qualitative findings from a UK study. PLoS One. 2022;17(9):e0273428.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Farr JN, Jenkins JJ, Paterson DG. Simplification of flesch reading ease formula. J Appl Psychol. 1951;35(5):333.

Article  Google Scholar 

Rogers G, Davies D, Pink J, Cooper P. Parkinson’s disease: summary of updated NICE guidance. BMJ. 2017;358:j1951.

Article  PubMed  Google Scholar 

Walters K, Frost R, Kharicha K, Avgerinou C, Gardner B, Ricciardi F, et al. Home-based health promotion for older people with mild frailty: the HomeHealth intervention development and feasibility RCT. Health Technol Assess (Winchester, England). 2017;21(73):1.

Article  Google Scholar 

Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson’s disease quality of life questionnaire and its associated measures. J Neurol. 1998;245(1):S10–4.

Article  PubMed  Google Scholar 

Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008;23(15):2129–70.

Article  PubMed  Google Scholar 

Martinez-Martin P, Schrag A, Weintraub D, Rizos A, Rodriguez-Blazquez C, Chaudhuri KR, et al. Pilot study of the international Parkinson and movement disorder society-sponsored non-motor rating scale (MDS-NMS). Mov Disord Clin Pract. 2019;6(3):227–34.

Article  PubMed  PubMed Central  Google Scholar 

Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256–62.

CAS  PubMed  Google Scholar 

Gureje O, Obikoya B. The GHQ-12 as a screening tool in a primary care setting. Soc Psychiatry Psychiatr Epidemiol. 1990;25(5):276–80.

Article  CAS  PubMed  Google Scholar 

Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39(41p):1005–26.

Article  PubMed  PubMed Central  Google Scholar 

Hoefman R, Van Exel N, Brouwer W. iMTA valuation of informal care questionnaire. 2015.

Google Scholar 

McCrone P. Capturing the costs of end-of-life care: Comparisons of multiple sclerosis, Parkinson’s disease, and dementia. J Pain Symptom Manage. 2009;38(1):62–7.

Article  PubMed  Google Scholar 

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Flynn TN, Chan P, Coast J, Peters TJ. Assessing quality of life among British older people using the ICEPOP CAPability (ICECAP-O) measure. Appl Health Econ Health Policy. 2011;9(5):317–29.

Article  PubMed  Google Scholar 

Yap P. Validity and reliability of the Zarit Burden Interview in assessing caregiving burden. Ann Acad Med Singapore. 2010;39:758–63.

Article  PubMed  Google Scholar 

Pillas M, Selai C, Quinn NP, Lees A, Litvan I, Lang A, et al. Development and validation of a carers quality-of-life questionnaire for parkinsonism (PQoL Carers). Qual Life Res. 2016;25(1):81–8.

Article  PubMed  Google Scholar 

Horváth K, Aschermann Z, Kovács M, Makkos A, Harmat M, Janszky J, et al. Changes in quality of life in Parkinson’s disease: how large must they be to be relevant? Neuroepidemiology. 2017;48(1–2):1–8.

Article  PubMed  Google Scholar 

Peto V, Jenkinson C, Fitzpatrick R. Determining minimally important differences for the PDQ-39 Parkinson’s disease questionnaire. Age Ageing. 2001;30(4):299–302.

Article  CAS  PubMed  Google Scholar 

Jenkinson C, Fitzpatrick R, Peto V, Dummett S, Morley D, Saunders P. The Parkinson’s disease questionnaire. Health Services Research Unit Oxford: Joshua Horgan Print Partnership. 1998. Available from: https://innovation.ox.ac.uk/wp-conontent/uploads/2014/09/PDQ_Manual_ExecSummary_and_Contents-1-orign1.pdf.

Horváth K, Aschermann Z, Ács P, Deli G, Janszky J, Komoly S, et al. Minimal clinically important difference on the Motor Examination part of MDS-UPDRS. Parkinsonism Relat Disord. 2015;21(12):1421–6.

Article  PubMed  Google Scholar 

Hunter RM, Baio G, Butt T, Morris S, Round J, Freemantle N. An educational review of the statistical issues in analysing utility data for cost-utility analysis. Pharmacoeconomics. 2015;33(4):355–66.

Coast J, Flynn TN, Natarajan L, Sproston K, Lewis J, Louviere JJ, et al. Valuing the ICECAP capability index for older people. Soc Sci Med. 2008;67(5):874–82.

Article  PubMed  Google Scholar 

Jones KC, Weatherly H, Birch S, Castelli A, Chalkley M, Dargan A, et al. Unit Costs of Health and Social Care 2022 Manual. 2022.

Google Scholar 

NHS England, Improvement National Cost Collection 2019. NHS England and NHS Improvement. 2020. https://www.england.nhs.uk/wp-content.

JF Committee. British National formulary (online). London: BMJ group and pharmaceutical press; 2016.

Google Scholar 

Hunter R, Proctor G, Noyce A, Schrag A, Ward E, Galloway J. Research into biomarkers to facilitate the early identification of Parkinson’s disease: a decision analytic model to determine the feasibility and value. Trials. 2013;14(1):1.

Google Scholar 

Comments (0)

No login
gif