Plain English Summary
Background and study aims
Multiple sclerosis (MS) is a complex, chronic and progressive disease where rehabilitation services offer important support to patients. Few MS rehabilitation programs have been shown to provide health improvements to patients in a cost-effective manner. The aim of this study is to assess the effect in terms of changes in quality of life from a highly specialized, individually planned and coherent rehabilitation program for people with MS.
Who can participate?
Patients with MS referred to the two Danish Sclerosis hospitals for a 4-week rehabilitation program.
What does the study involve?
Participants will be randomly allocated to either advanced admission (within 2 months) or usual admission (after an average waiting time of 8 months).
What are the possible benefits and risks of participating?
The results of the study would be relevant for further development of the MS rehabilitation services and for discussions about the design and contents of such services. The results will also be relevant for health authorities with responsibility for providing and financing rehabilitation services. We believe that there are no risks of participating in the study.
Where is the study run from?
The two Danish Sclerosis Hospitals at Haslev and Ry, Denmark.
When is the study starting and how long is it expected to run for?
Patient recruitment ran from March 2012 to March 2013. Data collection is expected to be completed summer 2014.
Who is funding the study?
The Sclerosis Hospitals and the Danish Multiple Sclerosis Society (Denmark).
Who is the main contact?
Prof Jan Sørensen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of highly specialized rehabilitation of patients with multiple sclerosis: a randomized controlled trial of personalized, targeted and multidisciplinary interventions
Acronym
Study hypothesis
The primary aim of the study is to assess the effect of personalized, targeted and multidisciplinary interventions in terms of changes in disease-specific quality of life measures.
As secondary aims the study aims at answering the following questions:
1. To what extent are the observed effects maintained 6 and 12 months after discharge?
2. How do different dimensions of quality of life, functional abilities and more specific measurements of sleep, daily activities, gait, balance and urinary retention correlate?
3. Which individual goals were set before the start of the rehabilitation?
4. What functions and priorities are at the focus of the individualized rehabilitation program?
5. What specific and measurable actions are included in the individual rehabilitation program?
6. What effect does the rehabilitation process have on the individual goals and priorities at discharge?
7. To what extent do patients maintain and integrate coping, immediately after discharge?
8. Which resource use and costs occur at the individual rehabilitation program for patients and their relatives, and for the rest of the healthcare system?
9. What is the relationship between the obtained effects and costs, 6 months after discharge?
Ethics approval
1. Scientific Ethics Committee of Region Sealand (Region Sjælland, Kvalitet og Udvikling, DK-4180 Sorø), 07/02/2012, ref: journal no. 1-01-0002-07 (experiment SJ-281)
2. Registered with the Danish Data Agency (Datatilsynet, Borgergade 28,5, DK-1300 Copenhagen K), ref: journal no. 2011-41-6751
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Multiple sclerosis
Intervention
Patients who fulfil the inclusion criteria and have signed the consent form will be randomised to either the intervention group, which includes early rehabilitation (after less than 2 months from referral), or the control group, who are provided with rehabilitation after the usual waiting time (approximately 8 months after referral).
When admitted both groups will receive a personalized, targeted and multidisciplinary hospital-based rehabilitation program organized during four weeks of continuous hospitalization. The rehabilitation team is composed based on the patient's individualised needs and may include a neuro-psychologist, clinical psychologist, occupational therapist, physiotherapist, nutritional therapist or dietitian, nurse, healthcare assistant, nursing assistant and social worker. Symptomatic drug therapy is organized or administered as part of the effort after the usual guidelines and overall judgment by the neurologist.
The patient's counselor is responsible for the content of the patient's program and should oversee that it contributes to the work of the team and patient, works towards the agreed objectives and milestones, and that needed adjustments are made during hospitalization. The counselor and patient evaluate the program, for example by weekly conversations and at discharge. According to the patient's desire, relatives and other team members may participate in one or more of the talks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Changes in Multiple Sclerosis Impact Scale version 2 (MSIS-29) and Functional Assessment of Multiple Sclerosis (FAMS) measured at baseline, at the start of the intervention, at intervention completion, 1, 6 and 12 months after baseline.
Secondary outcome measures
1. Mastery: Health Education Impact Questionnaire (heiQ)
2. Generic Quality of Life: EQ-5D and 15D
3. Expanded Disability Status Scale score (EDSS)
4. Resource consumption and costs for hospitals sclerosis for patients and their relatives, and for the rest of the healthcare service
Measured at baseline, at the start of the intervention, at intervention completion, 1, 6 and 12 months after baseline.
Overall trial start date
01/03/2012
Overall trial end date
30/06/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Study participants will be recruited among all patients who are referred to the 4-week individual rehabilitation program during March 2012 to June 2013. Patients who are referred for a shorter rehabilitation program or theme courses are not eligible for the study.
Participants must meet the following inclusion criteria:
1. Aged between 18 and 65 years
2. Diagnosis of multiple sclerosis (MS): relapsing remitting, primary or secondary progressive MS
3. Expanded Disability Status Scale (EDSS) score ≤ 7.5
4. Can use a PC or have support/relative who can
5. Ability to read and understand sufficient Danish to understand instructions both orally and in writing, and having completed a consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2 x 200
Participant exclusion criteria
1. MS disease duration less than 6 months (the period from diagnosis to referral)
2. Experienced relapse within 3 months before the neurological appraisal
3. Recipient of sclerosis-specific hospital-based rehabilitation within the last 6 months
4. Cognition score, Kurtzke's Functional Systems (KFS) > 2 or cognitive limitations which hinder completion of self-reported questionnaires and/or giving informed consent
5. Moderate to severe depression; severe heart or lung disease
6. Drug or alcohol abuse
7. Any other illness that can impede participation in the study
If participants develop a disease that might impair their participation in the study they will be excluded from the study at that time.
Recruitment start date
01/03/2012
Recruitment end date
01/03/2013
Locations
Countries of recruitment
Denmark
Trial participating centre
Centre for Applied Health Services Research and Technology Assessment
Odense
DK-5000
Denmark
Sponsor information
Organisation
The Danish Sclerosis Hospitals (Denmark)
Sponsor details
Ringstedvej 106
Haslev
DK-4690
Denmark
Sponsor type
Hospital/treatment centre
Website
http://temp.scleroseforeningen.dk/sclerosecentrene,-d-,dk.aspx
Funders
Funder type
Hospital/treatment centre
Funder name
The Sclerosis Hospitals (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Scleroseforeningen
Alternative name(s)
Danish Multiple Sclerosis Society, Danish MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Denmark
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22954027
Publication citations
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Protocol
Sørensen J, Lee A, Løvendahl B, Nørgaard M, Bay J, Rasmussen PV, Boesen F, Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention., BMC Health Serv Res, 2012, 12, 306, doi: 10.1186/1472-6963-12-306.