Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis.
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ABSTRACT:
SUBMITTER: Freeman J
PROVIDER: S-EPMC7646281 | biostudies-literature | 2019 Aug
REPOSITORIES: biostudies-literature
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Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis.
Freeman Jennifer J Hendrie Wendy W Jarrett Louise L Hawton Annie A Barton Andrew A Dennett Rachel R Jones Ben B Zajicek John J Creanor Siobhan S
The Lancet. Neurology 20190801 8
<h4>Background</h4>People severely impaired with progressive multiple sclerosis spend much of their day sitting, with very few options to improve motor function. As a result, secondary physical and psychosocial complications can occur. Effective and feasible self-management strategies are needed to reduce sedentary behaviour and enhance motor function. In this study, we aimed to assess the clinical and cost effectiveness of a home-based, self-managed, standing frame programme.<h4>Methods</h4>SUM ...[more]
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Project description:ObjectivesThe study aim was to explore the experiences of people with progressive multiple sclerosis (MS) and their standing assistants during their participation in Standing Up in Multiple Sclerosis, a randomised controlled trial (RCT) of a home-based, self-managed standing frame programme.DesignA qualitative approach, using audio diary methodology was used to collect data contemporaneously. Diary data were transcribed verbatim and analysed using thematic analysis.SettingParticipants were recruited from eight healthcare organisations in two regions of the UK. The intervention was home-based.ParticipantsAs part of the RCT, 140 participants were randomly allocated to either usual care or usual care plus a standing frame programme. Using a sampling matrix 12 people with progressive MS (6 female, aged 35-71 years, Expanded Disability Status Scale 6.5-8.0) and 8 standing assistants (4 female) kept audio diaries of their experiences.InterventionThe standing frame programme involved two face-to-face home-based physiotherapy sessions to set up the standing frame programme, supplemented by educational material designed to optimise self-efficacy. Participants were encouraged to stand for at least 30 min, three times a week for the 36-week study period.ResultsFour main themes were identified: "Feeling like the old me"; 'Noticing a difference'; "I want to do it right" and "You have a good day, you have a bad day".ConclusionsSupported standing helped people with progressive MS feel more like their old selves and provided a sense of normality and enjoyment. People noticed improvements in physical and psychological symptoms, which were often associated with increased participation in activities they valued. Provision of support from a physiotherapist and recognition of the variable nature of the condition were highlighted as factors to consider when establishing a standing programme.Trial registration numberISRCTN69614598.
| S-EPMC7594359 | biostudies-literature
Project description:BackgroundFatigue is a common and troubling symptom for people with multiple sclerosis (MS).AimTo evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).MethodsThree-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire).ResultsBetween May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue.ConclusionsFACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity.Trial registrationCurrent Controlled Trials ISRCTN76517470.
| S-EPMC3786656 | biostudies-literature
Project description:BackgroundEarly mobilisation (> 24 h post-stroke) is recommended for people with stroke. However, there is a paucity of evidence about how to implement early mobilisation for people who have had a severe stroke. Prolonged standing and task-specific training (sit-to-stand repetitions) have separately been evaluated in the literature; however, these functionally linked tasks have not been evaluated in combination for people with severe sub-acute stroke.MethodsThe objective was to determine the feasibility of conducting a randomised controlled trial (RCT) of a functional standing frame programme compared with usual physiotherapy for people with severe sub-acute stroke. An assessor-blinded feasibility RCT with nested qualitative component (interviews and focus group) and process evaluation was adopted. Participants were aged ≥ 18 years with new diagnosis of severe sub-acute stroke (modified Rankin Scale (mRS) 4/5) from four Stroke Rehabilitation Units across South West England. Participants were randomised to receive either: (1) functional standing frame programme (30 min. standing plus sit-to-stand repetitions) plus 15 min of usual physiotherapy daily (intervention); (2) usual physiotherapy (45 min) daily (control). Both programmes were protocolised to be undertaken a minimum of five sessions per week for 3 weeks. Feasibility indicators included process, resource, management, and safety. Adherence, fidelity, and acceptability of the trial and intervention were evaluated using data recorded by therapists, observation of intervention and control sessions, interviews and one focus group. Patient measures of motor impairment, activities/participation, and quality of life were carried out by blinded assessors at baseline, 3, 15, 29, and 55 weeks post-randomisation.ResultsForty-five participants (51-96 years; 42% male, mRS 4 = 80% 5 = 20%) were randomised (n = 22 to intervention). Twenty-seven (60%) participants were followed-up at all time points. Twelve participants (27%) died during the trial; no deaths were related to the trial. Adherence to the minimum number of sessions was low: none of the participants completed all 21 sessions, and only 8 participants (18%) across both groups completed ≥ 15 sessions, over the 3 weeks; 39% intervention; 51% control sessions were completed; mean session duration 39 min (SD 19) control, 37 min intervention (SD 11). Intervention group: mean standing time 13 min (SD 9); mean sit-to-stand repetitions/session 5 (SD 4). Interviews were conducted with 10 participants, four relatives and six physiotherapists. Five physiotherapists attended a focus group.ConclusionsThe majority of progression criteria for this feasibility trial were met. However, adherence to the interventions was unacceptably low. This aspect of the trial design needs to be addressed prior to moving to a definitive RCT of this standing frame intervention in people with severe sub-acute stroke. Solutions have been identified to address these concerns.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN15412695 . Registration 19 December 2016.
| S-EPMC8892736 | biostudies-literature
Project description:Progressive multiple sclerosis
| PRJNA966951 | ENA
Project description:The purpose of this study is to highlight the pathological features and clinical aspects of progressive multiple sclerosis (PMS) and also the results of clinical trial experience to date and review ongoing clinical trials and prospective new treatment options. This study will explain the challenges of clinical trial design in PMS.Multiple sclerosis (MS) has been identified as a chronic immune mediated disease, and the progressive phase of the disease appears to have significant neurodegenerative mechanisms. The classification of the course of PMS has been reorganized into categories of active vs. inactive inflammatory disease and the presence vs. absence of gradual disease progression. This differentiation allows clearer conceptualization of PMS and possibly even more efficient recruitment of PMS patients into clinical trials. Clinical trial experience to date in PMS has been negative with anti-inflammatory medications used in relapsing MS. Simvastatin was recently tested in a phase II trial and showed a 43% reduction of annualized atrophy progression in secondary progressive MS. Ongoing PMS trials are currently being conducted with the phosphodiesterase inhibitor ibudilast, S1P modulator siponimod and anti-B-cell therapy ocrelizumab. Several efforts for development of outcome measures in PMS are ongoing.PMS represents a significant challenge, as the pathogenesis of the disease is not well understood, no validated outcome metrics have been established and clinical trial experience to date has been disappointing. Advances in the understanding of the disease and lessons learned in previous clinical trials are paving the way for successful development of disease-modifying agents for this disease.
| S-EPMC4425257 | biostudies-other
Project description:This SuperSeries is composed of the SubSeries listed below.
2024-06-20 | GSE231587 | GEO
Project description:BackgroundAll children should have the possibility to be healthy during childhood, according to the Convention on the Rights of the Child. In Sweden, the Child Health Services (CHS) support all parents and children from birth until the age of six to promote children's health and development. Some Swedish regions have introduced an extended home-visit programme, with CHS nurses and social workers visiting first-time parents together to provide parental support in collaboration. The programme aims to expand the task of promoting the child's health and increase the possibilities of discovering risk factors in families earlier. The aim of the present study is to describe the professionals' experiences of collaboration when introducing the extended home-visit programme to a broader population within the frame of a family centre.MethodsThe study used a reflexive thematic qualitative approach with focus group interviews. All staff at the family centre were invited to participate: CHS nurses, social workers, and managers who worked with the extended home-visit programme. Data were collected through focus group interviews with each profession separately and analysed through reflexive thematic analysis.ResultsOne overarching theme emerged: A key to facilitating early support. Three connected themes - Ease for everyone on the family's terms, From working alone to becoming a team, and A matter of supporting structures - illuminated the participants' experiences. Their driving force was early detection of risk factors or needs in the family, to be able to provide support. The collaboration was enhanced by the different professional competencies complementing each other. That all were located at the family centre together was also important to facilitate collaboration.ConclusionsThe extended home-visits were appreciated and experienced as useful by all participants. That a family centre organization already existed was one of the facilitators, functioning as a meeting point to expand the collaboration. The managers' support was essential, and it was experienced as positive that the organization invested resources to allow employees to participate in the development of the extended home-visit programmes. This way of working has the potential to add value for the children and families, and the CHS would benefit from using the extended home-visit programme further.
| S-EPMC11616361 | biostudies-literature
Project description:INTRODUCTION:Living donor kidney transplantation (LDKT) is the optimal treatment for most patients with end-stage renal disease (ESRD). However, there are numerous patients who cannot find a living kidney donor. Randomised controlled trials have shown that home-based education for patients with ESRD and their family/friends leads to four times more LDKTs. This educational intervention is currently being implemented in eight hospitals in the Netherlands. Supervision and quality assessment are being employed to maintain the quality of the intervention. In this study, we aim to: (1) conduct a cost-effectiveness analysis of the educational programme and its quality assurance system; (2) investigate the relationship between the quality of the implementation of the intervention and the outcomes knowledge, communication and LDKT activities; and (3) investigate policy implications. METHODS AND DESIGN:Patients with ESRD who do not have a living kidney donor are eligible to receive the home-based educational intervention. This is carried out by allied health transplantation professionals and psychologists across eight hospitals in the Netherlands. The cost-effectiveness analysis will be conducted with a Markov model. Cost data will be obtained from the literature. We will obtain the quality of life data from the patients who participate in the educational programme. Questionnaires on knowledge and communication will be used to measure the outcomes of the programme. Data on LDKT activities will be obtained from medical records up to 24 months after the education. A protocol adherence measure will be assessed by a third party by means of a telephone interview with the patients and the invitees. ETHICS AND DISSEMINATION:Ethical approval was obtained through all participating hospitals. Results will be disseminated through peer-reviewed publications and scientific presentations. Results of the cost-effectiveness of the educational programme will also be disseminated to the Dutch National Health Care Institute. TRIAL REGISTRATION NUMBER:NL6529.
| S-EPMC6475347 | biostudies-literature
Project description:ObjectiveWe estimated the cost-effectiveness of home fortification with micronutrient powder delivered in a sales-based programme in reducing the prevalence of Fe deficiency anaemia among children 6-59 months in Bangladesh.DesignCross-sectional interviews with local and central-level programme staff and document reviews were conducted. Using an activity-based costing approach, we estimated start-up and implementation costs of the programme. The incremental cost per anaemia case averted and disability-adjusted life years (DALY) averted were estimated by comparing the home fortification programme and no intervention scenarios.SettingThe home fortification programme was implemented in 164 upazilas (sub-districts) in Bangladesh.ParticipantsCaregivers of child 6-59 months and BRAC staff members including community health workers were the participants for this study.ResultsThe home fortification programme had an estimated total start-up cost of 35·46 million BDT (456 thousand USD) and implementation cost of 1111·63 million BDT (14·12 million USD). The incremental cost per Fe deficiency anaemia case averted and per DALY averted was estimated to be 1749 BDT (22·2 USD) and 12 558 BDT (159·3 USD), respectively. Considering per capita gross domestic product (1516·5 USD) as the cost-effectiveness threshold, the home fortification programme was highly cost-effective. The programme coverage and costs for nutritional counselling of the beneficiary were influential parameters for cost per DALY averted in the one-way sensitivity analysis.ConclusionsThe market-based home fortification programme was a highly cost-effective mechanism for delivering micronutrients to a large number of children in Bangladesh. The policymakers should consider funding and sustaining large-scale sales-based micronutrient home fortification efforts assuming the clear population-level need and potential to benefit persists.
| S-EPMC8042576 | biostudies-literature
Project description:Aim Although cardiac rehabilitation improves physical fitness after a cardiac event, many eligible patients do not participate in cardiac rehabilitation and the beneficial effects of cardiac rehabilitation are often not maintained over time. Home-based training with telemonitoring guidance could improve participation rates and enhance long-term effectiveness. Methods and results We randomised 90 low-to-moderate cardiac risk patients entering cardiac rehabilitation to three months of either home-based training with telemonitoring guidance or centre-based training. Although training adherence was similar between groups, satisfaction was higher in the home-based group ( p = 0.02). Physical fitness improved at discharge ( p < 0.01) and at one-year follow-up ( p < 0.01) in both groups, without differences between groups (home-based p = 0.31 and centre-based p = 0.87). Physical activity levels did not change during the one-year study period (centre-based p = 0.38, home-based p = 0.80). Healthcare costs were statistically non-significantly lower in the home-based group (€437 per patient, 95% confidence interval -562 to 1436, p = 0.39). From a societal perspective, a statistically non-significant difference of €3160 per patient in favour of the home-based group was found (95% confidence interval -460 to 6780, p = 0.09) and the probability that it was more cost-effective varied between 97% and 75% (willingness-to-pay of €0 and €100,000 per quality-adjusted life-years, respectively). Conclusion We found no differences between home-based training with telemonitoring guidance and centre-based training on physical fitness, physical activity level or health-related quality of life. However, home-based training was associated with a higher patient satisfaction and appears to be more cost-effective than centre-based training. We conclude that home-based training with telemonitoring guidance can be used as an alternative to centre-based training for low-to-moderate cardiac risk patients entering cardiac rehabilitation.
| S-EPMC5518918 | biostudies-literature