Effects of highly specialized rehabilitation of patients with multiple
Effects of highly specialized rehabilitation of patients with multiple sclerosis: a randomized controlled trial of personalized, targeted and multidisciplinary interventions
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
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.
Quality of life (reported by participants)
Other measures (1)
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 baselin
Disability progressionQuality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: 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 Exclusion: 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Results
Can inpatient multidisciplinary rehabilitation improve health-related quality of life in MS patients on the long term - The Danish MS Hospitals Rehabilitation Study.Mult Scler · 2020
Results
Longer term effectiveness of inpatient multidisciplinary rehabilitation on health-related quality of life in MS patients: a pragmatic randomized controlled trial - The Danish MS Hospitals Rehabilitation Study.Mult Scler · 2018
Results
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
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History
Started
Mar 2012
Finished
Jun 2013