ECTRIMS eLearning

Standing up in people with progressive multiple sclerosis (SUMS): a multi-centre randomised controlled trial evaluating a home-based standing frame programme
Author(s): ,
J. Freeman
Affiliations:
Faculty of Health and Human Sciences, Plymouth University, Plymouth
,
W. Hendrie
Affiliations:
Faculty of Health and Human Sciences, Plymouth University, Plymouth; Norwich MS Centre, Norwich
,
L. Jarrett
Affiliations:
Faculty of Health and Human Sciences, Plymouth University, Plymouth; Mardon Neurorehabilitation Unit, Royal Devon and Exeter NHS foundation Trust
,
H. Anne Marie
Affiliations:
Health Economics Group, University of Exeter Medical School, Exeter
,
A. Barton
Affiliations:
NIHR Research Design Service
,
D. Rachel
Affiliations:
Faculty of Health and Human Sciences, Plymouth University, Plymouth
,
B. Jones
Affiliations:
Medical Statistics Group, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth
,
J. Marsden
Affiliations:
Faculty of Health and Human Sciences, Plymouth University, Plymouth
,
J. Zajicek
Affiliations:
School of Medicine, Medical and Biological Sciences, University of St Andrews, St Andrews
S. Creanor
Affiliations:
Medical Statistics Group, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth; Peninsula Clinical Trials Unit, Plymouth University, Plymouth, United Kingdom
ECTRIMS Learn. Freeman J. 10/12/18; 229107; P1267
Jennifer Freeman
Jennifer Freeman
Contributions
Abstract

Abstract: P1267

Type: Poster Sessions

Abstract Category: Therapy - Symptomatic treatment

Introduction: Severely impaired people with progressive MS spend much of their day sitting. In response, secondary physical and psychosocial complications can occur. Effective self-management strategies, feasible to implement within people's homes, are needed but are challenging.
Aims and objectives: To assess the clinical and cost-effectiveness of a home-based, self-managed, standing frame programme
Methods: A pragmatic, multi-centre, definitive randomised controlled trial with blinded outcome assessments at baseline, 20 and 36 weeks post baseline and full economic evaluation. Those allocated to the intervention group were asked to stand for a minimum of 30 minutes three times weekly over 20 weeks. The primary clinical outcome was motor function (Amended Motor Club Assessment) and primary economic endpoint was quality-adjusted life years (QALYs, based on the EQ-5D). Participants recorded adherence to the standing programme in a diary, together with adverse events.
Analysis used an intention-to-treat approach, utilising analysis of covariance, comparing AMCA scores at week 36 between allocated groups, adjusting for baseline AMCA and stratification factors (baseline Expanded Disability Status Scale [EDSS] category, geographical region). Costs, QALYs, and cost-effectiveness were estimated over the 36 week follow-up, adjusting for baseline values.
Results: 140 people with progressive MS (mean [sd]: age 59.1 years [9.4], EDSS 7.3 [0.6]; 64% female, 69% secondary progressive, 71% daily wheelchair user) were recruited from eight centres, of whom 12 participants withdrew. The adjusted AMCA at week 36 was statistically significantly higher in the standing frame group (n=61) compared to the control group (n=61) (adjusted between-group difference 4.7 [95% confidence interval 1.9 to 7.5], p=0.001). The standing frame intervention cost approximately £14,733 to the NHS/Personal Social Services per QALY gained.
Conclusions: This is the first large scale multi-centre trial to assess the clinical and cost-effectiveness of a home based, self-managed standing frame programme in people severely impaired by progressive MS. Our results demonstrate that the standing frame intervention was feasible to implement, resulted in statistically significant benefits in motor function compared to usual care alone, and is cost-effective in line with the threshold employed by the National Institute for Health and Care Excellence.
Disclosure: Source of funding: This study was funded by the NIHR RfPB programme (project number PB-PG-1013-32047).
Disclosures: None of the authors have anything to disclose.

Abstract: P1267

Type: Poster Sessions

Abstract Category: Therapy - Symptomatic treatment

Introduction: Severely impaired people with progressive MS spend much of their day sitting. In response, secondary physical and psychosocial complications can occur. Effective self-management strategies, feasible to implement within people's homes, are needed but are challenging.
Aims and objectives: To assess the clinical and cost-effectiveness of a home-based, self-managed, standing frame programme
Methods: A pragmatic, multi-centre, definitive randomised controlled trial with blinded outcome assessments at baseline, 20 and 36 weeks post baseline and full economic evaluation. Those allocated to the intervention group were asked to stand for a minimum of 30 minutes three times weekly over 20 weeks. The primary clinical outcome was motor function (Amended Motor Club Assessment) and primary economic endpoint was quality-adjusted life years (QALYs, based on the EQ-5D). Participants recorded adherence to the standing programme in a diary, together with adverse events.
Analysis used an intention-to-treat approach, utilising analysis of covariance, comparing AMCA scores at week 36 between allocated groups, adjusting for baseline AMCA and stratification factors (baseline Expanded Disability Status Scale [EDSS] category, geographical region). Costs, QALYs, and cost-effectiveness were estimated over the 36 week follow-up, adjusting for baseline values.
Results: 140 people with progressive MS (mean [sd]: age 59.1 years [9.4], EDSS 7.3 [0.6]; 64% female, 69% secondary progressive, 71% daily wheelchair user) were recruited from eight centres, of whom 12 participants withdrew. The adjusted AMCA at week 36 was statistically significantly higher in the standing frame group (n=61) compared to the control group (n=61) (adjusted between-group difference 4.7 [95% confidence interval 1.9 to 7.5], p=0.001). The standing frame intervention cost approximately £14,733 to the NHS/Personal Social Services per QALY gained.
Conclusions: This is the first large scale multi-centre trial to assess the clinical and cost-effectiveness of a home based, self-managed standing frame programme in people severely impaired by progressive MS. Our results demonstrate that the standing frame intervention was feasible to implement, resulted in statistically significant benefits in motor function compared to usual care alone, and is cost-effective in line with the threshold employed by the National Institute for Health and Care Excellence.
Disclosure: Source of funding: This study was funded by the NIHR RfPB programme (project number PB-PG-1013-32047).
Disclosures: None of the authors have anything to disclose.

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