Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Health Services Research
Published in: BMC Health Services Research 1/2012

Open Access 01-12-2012 | Study protocol

Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention

Authors: Jan Sørensen, Anne Lee, Brita Løvendahl, Michael Nørgaard, Jette Bay, Peter Vestergaard Rasmussen, Finn Boesen

Published in: BMC Health Services Research | Issue 1/2012

Login to get access

Abstract

Background

Multiple sclerosis (MS) is a complex, chronic and progressive disease and rehabilitation services can provide important support to patients. Few MS rehabilitation programs have been shown to provide health improvements to patients in a cost-effective manner. The objective of this study is to assess the effects in terms of changes measured by a variety of standardized quality of life, mastery, coping, compliance and individual goal-related endpoints. This combination provides the basis for analyzing the complexity of MS and outcomes of a personalized rehabilitation.

Methods/Design

Patients with MS referred to hospital rehabilitation services will be randomized to either early admission (within two months) or usual admission (after an average waiting time of eight months). They will complete a battery of standardized health outcome instruments prior to randomization, and again six and twelve months after randomization, and a battery of goal-related outcome measures at admission and discharge, and again one, six and twelve months after randomization.

Discussion

The results of the study are expected to contribute to further development of MS rehabilitation services and to discussions about the design and content of such services. The results will also provide additional information to health authorities responsible for providing and financing rehabilitation services.

Trial registration

Current Controlled Trials (ISRCTN05245917)
Appendix
Available only for authorised users
Literature
1.
Bentzen J, Flachs EM, Stenager E, Bronnum-Hansen H, Koch-Henriksen N: Prevalence of multiple sclerosis in Denmark 1950–2005. Mult Scler. 2010, 16 (5): 520-525. 10.1177/1352458510364197.CrossRefPubMed
2.
Khan F, Turner-Stokes L, Ng L, Kilpatrick T: Multidisciplinary rehabilitation for adults with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2008, 79 (2): 114.PubMed
3.
Burks JS, Bigley GK, Hill HH: Rehabilitation challenges in multiple sclerosis. Annals of Indian Academy of Neurology. 2009, 12 (4): 296-306. 10.4103/0972-2327.58273.CrossRefPubMedPubMedCentral
4.
Gawronski KM, Rainka MM, Patel MJ, Gengo FM: Treatment options for multiple sclerosis: current and emerging therapies. Pharmacotherapy. 2010, 30 (9): 916-927. 10.1592/phco.30.9.916.CrossRefPubMed
5.
Hundborg K: The Danish quality model. Ugeskrift for laeger. 2009, 171 (20): 1660-1663.PubMed
6.
Khan F, Turner-Stokes L, Ng L, Kilpatrick T: Multidisciplinary rehabilitation for adults with multiple sclerosis. Cochrane Database Syst Rev. 2007, CD006036-2
7.
Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G: Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005, CD003980-1
8.
Sorensen J: Analysis of quality of life assessed by "Functional Assessment in Multiple Sclerosis" (FAMS) among individuals who have participated in individualzed rehabilitation at the Sclerosis Hospitals at Ry and Haslev] in Danish. 2010, Odense, Denmark: University of Southern Denmark
9.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, group C, Pragmatic Trials in Healthcare g: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral
10.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council G: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008, 337: a1655-10.1136/bmj.a1655.CrossRefPubMedPubMedCentral
11.
Kurtzke JF: Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983, 33 (11): 1444-1452. 10.1212/WNL.33.11.1444.CrossRefPubMed
12.
Collin C, Wade DT, Davies S, Horne V: The Barthel ADL Index: a reliability study. Int Disability Stud. 1988, 10 (2): 61-63. 10.3109/09638288809164103.CrossRef
13.
Wade DT, Collin C: The Barthel ADL Index: a standard measure of physical disability?. Int Disability Stud. 1988, 10 (2): 64-67. 10.3109/09638288809164105.CrossRef
14.
Maribo T, Lauritsen JM, Waehrens E, Poulsen I, Hesselbo B: [Barthel Index for evaluation of function: a Danish consensus on its use]. Ugeskrift for laeger. 2006, 168 (34): 2790-2792.PubMed
15.
Beck AT: A systematic investigation of depression. Compr Psychiatry. 1961, 2: 163-170. 10.1016/S0010-440X(61)80020-5.CrossRefPubMed
16.
Cella DF, Dineen K, Arnason B, Reder A, Webster KA, Karabatsos G, Chang C, Lloyd S, Steward J, Stefoski D: Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology. 1996, 47 (1): 129-139. 10.1212/WNL.47.1.129.CrossRefPubMed
17.
Paterson C, Thomas K, Manasse A, Cooke H, Peace G: Measure Yourself Concerns and Wellbeing (MYCaW): an individualised questionnaire for evaluating outcome in cancer support care that includes complementary therapies. Complementary Therapies Med. 2007, 15 (1): 38-45. 10.1016/j.ctim.2006.03.006.CrossRef
18.
Vindeløv PKLA, Boesen F, Sorensen J: Centre for Applied Health Services Research and Technology Assessment report series. Danish pilot test of MYCaW: Pilot testing of the instrument MYCaW. In connection with the rehabilitation of the Danish Multiple Sclerosis Hospitals. 2011, Odense, Denmark: University of Southern Denmark
19.
Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N: The Canadian occupational performance measure: an outcome measure for occupational therapy. Canadian J Occup Therapy Revue canadienne d'ergotherapie. 1990, 57 (2): 82-87.CrossRefPubMed
20.
Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S: Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Canadian J Occup Therapy Revue canadienne d'ergotherapie. 1994, 61 (4): 191-197.CrossRefPubMed
21.
McColl MA, Paterson M, Davies D, Doubt L, Law M: Validity and community utility of the Canadian Occupational Performance Measure. Canadian J Occup Therapy Revue canadienne d'ergotherapie. 2000, 67 (1): 22-30.CrossRefPubMed
22.
Enemark Larsen A, Carlsson G: Utility of the Canadian Occupational Performance Measure as an admission and outcome measure in interdisciplinary community-based geriatric rehabilitation. Scand J Occup Ther. 2012, 19 (2): 204-213. 10.3109/11038128.2011.574151.CrossRefPubMed
23.
Dahl TH: International classification of functioning, disability and health: an introduction and discussion of its potential impact on rehabilitation services and research. J Rehabilitation Med: Official J UEMS European Board of Physical and Rehabilitation Medicine. 2002, 34 (5): 201-204.CrossRef
24.
Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A: The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain: J Neurology. 2001, 124 (Pt 5): 962-973.CrossRef
25.
Riazi A, Hobart JC, Lamping DL, Fitzpatrick R, Thompson AJ: Multiple Sclerosis Impact Scale (MSIS-29): reliability and validity in hospital based samples. J Neurol Neurosurg Psychiatry. 2002, 73 (6): 701-704. 10.1136/jnnp.73.6.701.CrossRefPubMedPubMedCentral
26.
Sorensen J, Bay J, Damsgaard T, Heeley E, Rostgaard I, Lovendahl B, Boesen F: Validation of the Danish version of functional assessment of multiple sclerosis: a quality of life instrument. Multiple Sclerosis Int. 2011, 2011: 121530.CrossRef
27.
Osborne RH, Elsworth GR, Whitfield K: The Health Education Impact Questionnaire (heiQ): an outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Edu Counseling. 2007, 66 (2): 192-201. 10.1016/j.pec.2006.12.002.CrossRef
28.
EuroQol: a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990, 16 (3): 199-208.CrossRef
29.
Gudex C, Sørensen J: EuroQoL: a generic measure for health status. Månedsskr Prakt Lægegern. 1998, 76 (October): 1339-1345.
30.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011, 20 (10): 1727-1736. 10.1007/s11136-011-9903-x.CrossRefPubMedPubMedCentral
31.
Sintonen H: The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001, 33 (5): 328-336. 10.3109/07853890109002086.CrossRefPubMed
32.
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD: The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989, 46 (10): 1121-1123. 10.1001/archneur.1989.00520460115022.CrossRefPubMed
33.
Kos D, Kerckhofs E, Carrea I, Verza R, Ramos M, Jansa J: Evaluation of the Modified Fatigue Impact Scale in four different European countries. Mult Scler. 2005, 11 (1): 76-80. 10.1191/1352458505ms1117oa.CrossRefPubMed
34.
Johns MW: A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991, 14 (6): 540-545.PubMed
35.
Smyth CA: Evaluating sleep quality in older adults: the Pittsburgh Sleep Quality Index can be used to detect sleep disturbances or deficits. Am J Nurs. 2008, 108 (5): 42-50. 10.1097/01.NAJ.0000317300.33599.63. quiz 50–41CrossRefPubMed
36.
Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F: Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res. 2002, 53 (3): 737-740. 10.1016/S0022-3999(02)00330-6.CrossRefPubMed
37.
38.
Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ: The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry research. 1989, 28 (2): 193-213. 10.1016/0165-1781(89)90047-4.CrossRefPubMed
39.
Solway S, Brooks D, Lacasse Y, Thomas S: A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001, 119 (1): 256-270. 10.1378/chest.119.1.256.CrossRefPubMed
40.
Brooks D, Solway S, Gibbons WJ: ATS statement on six-minute walk test. Am J Respir Crit Care Med. 2003, 167 (9): 1287.CrossRefPubMed
41.
Laboratories ATSCoPSfCPF: ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002, 166 (1): 111-117.CrossRef
42.
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ: Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003, 60 (1): 31-36. 10.1212/WNL.60.1.31.CrossRefPubMed
43.
McGuigan C, Hutchinson M: Confirming the validity and responsiveness of the Multiple Sclerosis Walking Scale-12 (MSWS-12). Neurology. 2004, 62 (11): 2103-2105. 10.1212/01.WNL.0000127604.84575.0D.CrossRefPubMed
44.
Bladh S, Nilsson MH, Hariz GM, Westergren A, Hobart J, Hagell P: Psychometric performance of a generic walking scale (Walk-12G) in multiple sclerosis and Parkinson's disease. J Neurol. 2012, 259 (4): 729-738. 10.1007/s00415-011-6254-z.CrossRefPubMed
45.
Motl RW, McAuley E, Mullen S: Longitudinal measurement invariance of the Multiple Sclerosis Walking Scale-12. J Neurol Sci. 2011, 305 (1–2): 75-79.CrossRefPubMed
46.
McConvey J, Bennett SE: Reliability of the Dynamic Gait Index in individuals with multiple sclerosis. Archives Physical Med Rehabilitation. 2005, 86 (1): 130-133. 10.1016/j.apmr.2003.11.033.CrossRef
47.
Tuomela J, Paltamaa J, Hakkinen A: Reliability of the Dynamic Gait Index (Finnish version) in individuals with neurological disorders. Disabil Rehabil. 2012, 34 (19): 1657-1664. 10.3109/09638288.2012.660602.CrossRefPubMed
48.
Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM: Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005, 85 (10): 1034-1045.PubMed
49.
Duncan RP, Leddy AL, Earhart GM: Five times sit-to-stand test performance in Parkinson's disease. Archives of physical medicine and rehabilitation. 2011, 92 (9): 1431-1436. 10.1016/j.apmr.2011.04.008.CrossRefPubMedPubMedCentral
50.
Mathiowetz V, Volland G, Kashman N, Weber K: Adult norms for the Box and Block Test of manual dexterity. The American J Occup Therapy: official publication of the American Occupational Therapy Association. 1985, 39 (6): 386-391. 10.5014/ajot.39.6.386.CrossRef
51.
Kragt JJ, van der Linden FA, Nielsen JM, Uitdehaag BM, Polman CH: Clinical impact of 20% worsening on Timed 25-foot Walk and 9-hole Peg Test in multiple sclerosis. Mult Scler. 2006, 12 (5): 594-598. 10.1177/1352458506070768.CrossRefPubMed
52.
Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L: The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurologic Physical Therapy: JNPT. 2011, 35 (4): 157-163.CrossRef
53.
Pavan K, Tilbery CP, Lianza S, Marangoni BE: Validation of the "Six Step Spot Test" for gait among patients with multiple sclerosis in Brazil. Arq Neuropsiquiatr. 2010, 68 (2): 198-204. 10.1590/S0004-282X2010000200009.CrossRefPubMed
54.
Nieuwenhuis MM, Van Tongeren H, Sorensen PS, Ravnborg M: The six spot step test: a new measurement for walking ability in multiple sclerosis. Mult Scler. 2006, 12 (4): 495-500. 10.1191/1352458506ms1293oa.CrossRefPubMed
55.
Schwartz CE, Coulthard-Morris L, Zeng Q, Retzlaff P: Measuring self-efficacy in people with multiple sclerosis: a validation study. Archives Physical Med Rehabilitation. 1996, 77 (4): 394-398. 10.1016/S0003-9993(96)90091-X.CrossRef
56.
Rigby SA, Domenech C, Thornton EW, Tedman S, Young CA: Development and validation of a self-efficacy measure for people with multiple sclerosis: the Multiple Sclerosis Self-efficacy Scale. Mult Scler. 2003, 9 (1): 73-81. 10.1191/1352458503ms870oa.CrossRefPubMed
57.
Airlie J, Baker GA, Smith SJ, Young CA: Measuring the impact of multiple sclerosis on psychosocial functioning: the development of a new self-efficacy scale. Clin Rehabil. 2001, 15 (3): 259-265. 10.1191/026921501668362643.CrossRefPubMed
58.
Perraud S: Development of the Depression Coping Self-Efficacy Scale (DCSES). Arch Psychiatr Nurs. 2000, 14 (6): 276-284. 10.1053/apnu.2000.19090.CrossRefPubMed
59.
Tucker S, Brust S, Richardson B: Validity of the depression coping self-efficacy scale. Arch Psychiatr Nurs. 2002, 16 (3): 125-133. 10.1053/apnu.2002.32949.CrossRefPubMed
60.
Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S: A validity and reliability study of the coping self-efficacy scale. Br J Heal Psychol. 2006, 11 (Pt 3): 421-437.CrossRef
61.
Mahoney FI, Barthel DW: Functional evaluation: the Barthel Index. Maryland State Medical J. 1965, 14: 61-65.
62.
Pan AW, Fisher AG: The Assessment of Motor and Process Skills of persons with psychiatric disorders. The American J Occup Therapy: official publication of the American Occupational Therapy Association. 1994, 48 (9): 775-780. 10.5014/ajot.48.9.775.CrossRef
63.
McNulty MC, Fisher AG: Validity of using the Assessment of Motor and Process Skills to estimate overall home safety in persons with psychiatric conditions. The American J Occup Therapy: official publication of the American Occupational Therapy Association. 2001, 55 (6): 649-655. 10.5014/ajot.55.6.649.CrossRef
64.
Feys P, Gijbels D, Romberg A, Santoyo C, Gebara B, de Noordhout BM, Knuts K, Bethoux F, de Groot V, Vaney C, et al: Effect of time of day on walking capacity and self-reported fatigue in persons with multiple sclerosis: a multi-center trial. Mult Scler. 2012, 18 (3): 351-357. 10.1177/1352458511419881.CrossRefPubMed
Metadata
Title
Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention
Authors
Jan Sørensen
Anne Lee
Brita Løvendahl
Michael Nørgaard
Jette Bay
Peter Vestergaard Rasmussen
Finn Boesen
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2012
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-12-306

Other articles of this Issue 1/2012

BMC Health Services Research 1/2012 Go to the issue

Research article

Cost-effectiveness analysis of neonatal hearing screening program in china: should universal screening be prioritized?

Research article

Measuring the value of older people's production: a diary study

Research article

An organisational analysis of the implementation of telecare and telehealth: the whole systems demonstrator

Research article

Stigma, an important source of dissatisfaction of health workers in HIV response in Vietnam: a qualitative study

Research article

Free choice of healthcare providers in the Netherlands is both a goal in itself and a precondition: modelling the policy assumptions underlying the promotion of patient choice through documentary analysis and interviews

Research article

Reducing the health disparities of Indigenous Australians: time to change focus