Journal articles
Snowsill T, Stathi A, Green C, Withall J, Greaves CJ, Thompson JL, Taylor G, Gray S, Johansen-Berg H, Bilzon JLJ, et al (In Press). Cost-effectiveness of a community-based physical activity and behaviour maintenance intervention for preventing decline in physical functioning in older people: an economic evaluation of the REACT (Retirement in Action) intervention. The Lancet Public Health
Stathi A, Greaves C, Thompson JL, Withall J, Ladlow P, Taylor G, Medina-Lara A, Snowsill T, Gray S, Green C, et al (In Press). Effect of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: the REACT (REtirement in ACTion) randomised controlled trial. The Lancet Public Health
Withall J, Greaves CJ, Thompson JL, de Koning JL, Bollen JC, Moorlock SJ, Fox KR, Western MJ, Snowsill T, Medina-Lara A, et al (In Press). The tribulations of trials: Lessons learnt recruiting 777 older adults into REtirement in ACTion (REACT), a trial of a community, group-based active ageing intervention targeting mobility disability. Journal of Gerontology: Medical Sciences
Goldsmith G, Bollen JC, Salmon VE, Freeman JA, Dean SG (2023). Adherence to physical rehabilitation delivered via tele-rehabilitation for people with multiple sclerosis: a scoping review protocol.
BMJ Open,
13(3), e062548-e062548.
Abstract:
Adherence to physical rehabilitation delivered via tele-rehabilitation for people with multiple sclerosis: a scoping review protocol
IntroductionUsing tele-rehabilitation methods to deliver exercise, physical activity (PA) and behaviour change interventions for people with multiple sclerosis (pwMS) has increased in recent years, especially since the SARS-CoV-2 pandemic. This scoping review aims to provide an overview of the literature regarding adherence to therapeutic exercise and PA delivered via tele-rehabilitation for pwMS.Methods and analysisFrameworks described by Arksey and O’Malley and Levacet alunderpin the methods. The following databases will be searched from 1998 to the present: Medline (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Health Management Information Consortium Database, ProQuest Dissertations and Theses Global, Pedro, Cochrane Central Register of Controlled Trials, US National Library of Medicine Registry of Clinical Trials, WHO International Clinical Trials Registry Platform portal and the Cochrane Database of Systematic Reviews. To identify papers not included in databases, relevant websites will be searched. Searches are planned for 2023. With the exception of study protocols, papers on any study design will be included. Papers reporting information regarding adherence in the context of prescribed therapeutic exercise and PA delivered via tele-rehabilitation for pwMS will be included. Information relating to adherence may comprise; methods of reporting adherence, adherence levels (eg, exercise diaries, pedometers), investigation of pwMS’ and therapists’ experiences of adherence or a discussion of adherence. Eligibility criteria and a custom data extraction form will be piloted on a sample of papers. Quality assessment of included studies will use Critical Appraisal Skills Programme checklists. Data analysis will involve categorisation, enabling findings relating to study characteristics and research questions to be presented in narrative and tabular format.Ethics and disseminationEthical approval was not required for this protocol. Findings will be submitted to a peer-reviewed journal and presented at conferences. Consultation with pwMS and clinicians will help to identify other dissemination methods.
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Ladlow P, Western MJ, Greaves CJ, Thompson JL, Withall J, de Koning J, Bollen JC, Moorlock SJ, Guralnik JM, Fox KR, et al (2023). The REtirement in ACTion exercise programme and its effects on elements of long term functionality in older adults. Frontiers in Public Health, 11
Stathi A, Withall J, Greaves CJ, Thompson JL, Taylor G, Medina-Lara A, Green C, Snowsill T, Johansen-Berg H, Bilzon J, et al (2022). A group-based exercise and behavioural maintenance intervention for adults over 65 years with mobility limitations: the REACT RCT.
Public Health Research,
10(14), 1-172.
Abstract:
A group-based exercise and behavioural maintenance intervention for adults over 65 years with mobility limitations: the REACT RCT
. Background
. Mobility limitation in older age reduces quality of life, generates substantial health- and social-care costs, and increases mortality.
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. Objective
. The REtirement in ACTion (REACT) trial aimed to establish whether or not a community-based active ageing intervention could prevent decline in physical functioning in older adults already at increased risk of mobility limitation.
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. Design
. A multicentre, pragmatic, two-arm, parallel-group randomised controlled trial with parallel process and health economic evaluations.
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. Setting
. Urban and semi-rural locations across three sites in England.
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. Participants
. Physically frail or pre-frail older adults (aged ≥ 65 years; Short Physical Performance Battery score of 4–9). Recruitment was primarily via 35 primary care practices.
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. Interventions
. Participants were randomly assigned to receive brief advice (three healthy ageing education sessions) or a 12-month, group-based, multimodal exercise and behavioural maintenance programme delivered in fitness and community centres. Randomisation was stratified by site and used a minimisation algorithm to balance age, sex and Short Physical Performance Battery score. Data collection and analyses were blinded.
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. Main outcome measures
. The primary outcome was change in lower limb physical function (Short Physical Performance Battery score) at 24 months, analysed using an intention-to-treat analysis. The economic evaluation adopted the NHS and Personal Social Services perspective.
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. Results
. Between June 2016 and October 2017, 777 participants (mean age 77.6 years, standard deviation 6.8 years; 66% female; mean Short Physical Performance Battery score 7.37, standard deviation 1.56) were randomised to the intervention arm (n = 410) or the control arm (n = 367). Data collection was completed in October 2019. Primary outcome data at 24 months were provided by 628 (80.8%) participants. At the 24-month follow-up, the Short Physical Performance Battery score was significantly greater in the intervention arm (mean 8.08, standard deviation 2.87) than in the control arm (mean 7.59, standard deviation 2.61), with an adjusted mean difference of 0.49 (95% confidence interval 0.06 to 0.92). The difference in lower limb function between intervention and control participants was clinically meaningful at both 12 and 24 months. Self-reported physical activity significantly increased in the intervention arm compared with the control arm, but this change was not observed in device-based physical activity data collected during the trial. One adverse event was related to the intervention. Attrition rates were low (19% at 24 months) and adherence was high. Engagement with the REACT intervention was associated with positive changes in exercise competence, relatedness and enjoyment and perceived physical, social and mental well-being benefits. The intervention plus usual care was cost-effective compared with care alone over the 2 years of REACT; the price year was 2019. In the base-case scenario, the intervention saved £103 per participant, with a quality-adjusted life-year gain of 0.04 (95% confidence interval 0.006 to 0.074) within the 2-year trial window. Lifetime horizon modelling estimated that further cost savings and quality-adjusted life-year gains were accrued up to 15 years post randomisation.
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. Conclusion
. A relatively low-resource, 1-year multimodal exercise and behavioural maintenance intervention can help older adults to retain physical functioning over a 24-month period. The results indicate that the well-established trajectory of declining physical functioning in older age is modifiable.
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. Limitations
. Participants were not blinded to study arm allocation. However, the primary outcome was independently assessed by blinded data collectors. The secondary outcome analyses were exploratory, with no adjustment for multiple testing, and should be interpreted accordingly.
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. Future work
. Following refinements guided by the process evaluation findings, the REACT intervention is suitable for large-scale implementation. Further research will optimise implementation of REACT at scale.
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. Trial registration
. This trial is registered as ISRCTN45627165.
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. Funding
. This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 14. See the NIHR Journals Library website for further project information.
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Abstract.
Snowsill TM, Stathi A, Green C, Withall J, Greaves CJ, Thompson JL, Taylor G, Gray S, Johansen-Berg H, Bilzon JLJ, et al (2022). Cost-effectiveness of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: an economic evaluation of the REACT (Retirement in Action) trial.
Lancet Public Health,
7(4), e327-e334.
Abstract:
Cost-effectiveness of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: an economic evaluation of the REACT (Retirement in Action) trial.
BACKGROUND: Mobility limitations in older populations have a substantial impact on health outcomes, quality of life, and social care costs. The Retirement in Action (REACT) randomised controlled trial assessed a 12-month community-based group physical activity and behaviour maintenance intervention to help prevent decline in physical functioning in older adults at increased risk of mobility limitation. We aimed to do an economic evaluation of the REACT trial to investigate whether the intervention is cost-effective. METHODS: in this health economic evaluation, we did cost-effectiveness and cost-utility analyses of the REACT programme versus standard care on the basis of resource use, primary outcome, and health-related quality-of-life data measured in the REACT trial. We also developed a decision analytic Markov model that forecasts the mobility of recipients beyond the 24-month follow-up of the trial and translated this into future costs and potential benefit to health-related quality of life using the National Health Service and Personal Social Services perspective. Participants completed questionnaire booklets at baseline, and at 6, 12, and 24 months after randomisation, which included a resource use questionnaire and the EQ-5D-5L and 36-item short-form survey (SF-36) health-related quality-of-life instruments. The cost of delivering the intervention was estimated by identifying key resources, such as REACT session leader time, time of an individual to coordinate the programme, and venue hire. EQ-5D-5L and SF-36 responses were converted to preference-based utility values, which were used to estimate quality-adjusted life-years (QALYs) over the 24-month trial follow-up using the area-under-the-curve method. We used generalised linear models to examine the effect of the REACT programme on costs and QALYs and adjust for baseline covariates. Costs and QALYs beyond 12 months were discounted at 3·5% per year. This is a pre-planned analysis of the REACT trial; the trial itself is registered with ISRCTN (ISRCTN45627165). FINDINGS: the 12-month REACT programme was estimated to cost £622 per recipient to deliver. The most substantial cost components are the REACT session leader time (£309 per participant), venue hire (£109), and the REACT coordinator time (£80). The base-case analysis of the trial-based economic evaluation showed that reductions in health and social care usage due to the REACT programme could offset the REACT delivery costs (£3943 in the intervention group vs £4043 in the control group; difference: -£103 [95% CI -£695 to £489]) with a health benefit of 0·04 QALYs (0·009-0·071; 1·354 QALYs in the intervention group vs 1·314 QALYs in the control group) within the 24-month timeframe of the trial. INTERPRETATION: the REACT programme could be considered a cost-effective approach for improving the health-related quality of life of older adults at risk of mobility limitations. FUNDING: National Institute for Health Research Public Health Research Programme.
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Richards DA, Sugg HVR, Cockcroft E, Cooper J, Cruickshank S, Doris F, Hulme C, Logan P, Iles-Smith H, Melendez-Torres GJ, et al (2021). COVID-NURSE: evaluation of a fundamental nursing care protocol compared with care as usual on experience of care for noninvasively ventilated patients in hospital with the SARS-CoV-2 virus—protocol for a cluster randomised controlled trial.
BMJ Open,
11(5), e046436-e046436.
Abstract:
COVID-NURSE: evaluation of a fundamental nursing care protocol compared with care as usual on experience of care for noninvasively ventilated patients in hospital with the SARS-CoV-2 virus—protocol for a cluster randomised controlled trial
IntroductionPatient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse–patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs.Methods and analysiswe aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual and a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared with care as usual. Our coprimary outcomes are patient-reported experience (Quality from the Patients’ Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression Patient Health Questionnaire-2 (PHQ-2), anxiety General Anxiety Disorder-2 (GAD-2), health utility (EQ5D) and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis, we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned subgroup analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations.Ethics and disseminationResearch governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer-reviewed scientific journals, study website, press and online media, including free online training materials on the Open University’s FutureLearn web platform.Trial registration numberISRCTN13177364; Pre-results.
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Gaboury I, Tousignant M, Corriveau H, Menear M, Le Dorze G, Rochefort C, Vachon B, Rochette A, Gosselin S, Michaud F, et al (2021). Effects of Telerehabilitation on Patient Adherence to a Rehabilitation Plan: Protocol for a Mixed Methods Trial.
JMIR Res Protoc,
10(10).
Abstract:
Effects of Telerehabilitation on Patient Adherence to a Rehabilitation Plan: Protocol for a Mixed Methods Trial.
BACKGROUND: Strong evidence supports beginning stroke rehabilitation as soon as the patient's medical status has stabilized and continuing following discharge from acute care. However, adherence to rehabilitation treatments over the rehabilitation phase has been shown to be suboptimal. OBJECTIVE: the aim of this study is to assess the impact of a telerehabilitation platform on stroke patients' adherence to a rehabilitation plan and on their level of reintegration into normal social activities, in comparison with usual care. The primary outcome is patient adherence to stroke rehabilitation (up to 12 weeks), which is hypothesized to influence reintegration into normal living. Secondary outcomes for patients include functional recovery and independence, depression, adverse events related to telerehabilitation, use of services (up to 6 months), perception of interprofessional shared decision making, and quality of services received. Interprofessional collaboration as well as quality of interprofessional shared decision making will be measured with clinicians. METHODS: in this interrupted time series with a convergent qualitative component, rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to deliver the treatment. The intervention will be comprised of 220 patients who will take part in stroke telerehabilitation with an interdisciplinary group of clinicians (telerehabilitation group) versus face-to-face standard of care (control group: n=110 patients). RESULTS: Our Research Ethics Board approved the study in June 2020. Data collection for the control group is underway, with another year planned before we begin the intervention phase. CONCLUSIONS: This study will contribute to the minimization of both knowledge and practice gaps, while producing robust, in-depth data on the factors related to the effectiveness of telerehabilitation in a stroke rehabilitation continuum. Findings will inform best practice guidelines regarding telecare services and the provision of telerehabilitation, including recommendations for effective interdisciplinary collaboration regarding stroke rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04440215; https://clinicaltrials.gov/ct2/show/NCT04440215. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32134.
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Testad I, Clare L, Anstey K, Selbæk G, Bjørkløf GH, Henderson C, Dalen I, Gjestsen MT, Rhodes S, Røsvik J, et al (2020). Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial.
BMC Public Health,
20(1).
Abstract:
Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial.
BACKGROUND: with an increasing number of people with dementia worldwide and limited advancement in medical treatments, the call for new and cost-effective approaches is crucial. The utility of self-management has been proven in certain chronic conditions. However, very little work has been undertaken regarding self-management in people with dementia. METHODS: the SHAPE trial will include 372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners. The study is a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm is compared with treatment as usual. The intervention comprises a 10-week course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the nature of the condition and the development of healthy behaviours in a supportive learning environment. An e-learning course will be provided for care partners which covers similar and complementary material to that discussed in the group sessions for the participant with dementia. DISCUSSION: This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04286139, registered prospectively February 26, 2020, https://clinicaltrials.gov/ct2/show/NCT04286139.
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Stathi A, Withall J, Greaves CJ, Thompson JL, Taylor G, Medina-Lara A, Green C, Bilzon J, Gray S, Johansen-Berg H, et al (2018). A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial.
Trials,
19(1).
Abstract:
A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial.
BACKGROUND: the REtirement in ACTion (REACT) study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial (RCT) with an internal pilot phase. It aims to test the effectiveness and cost-effectiveness of a community, group-based physical activity intervention for reducing, or reversing, the progression of functional limitations in older people who are at high risk of mobility-related disability. METHODS/DESIGN: a sample of 768 sedentary, community-dwelling, older people aged 65 years and over with functional limitations, but who are still ambulatory (scores between 4 and 9 out of 12 in the Short Physical Performance Battery test (SPPB)) will be randomised to receive either the REACT intervention, delivered over a period of 12 months by trained facilitators, or a minimal control intervention. The REACT study incorporates comprehensive process and economic evaluation and a nested sub-study which will test the hypothesis that the REACT intervention will slow the rate of brain atrophy and of decline in cognitive function assessed using magnetic resonance imaging (MRI). Outcome data will be collected at baseline, 6, 12 and 24 months for the main study, with MRI sub-study data collected at baseline, 6 and 12 months. The primary outcome analysis (SPPB score at 24 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: REACT represents the first large-scale, pragmatic, community-based trial in the UK to target the non-disabled but high-risk segment of the older population with an intervention to reduce mobility-related disability. A programme that can successfully engage this population in sufficient activity to improve strength, aerobic capacity, coordination and balance would have a major impact on sustaining health and independence. REACT is also the first study of its kind to conduct a full economic and comprehensive process evaluation alongside the RCT. If effective and cost-effective, the REACT intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN45627165. Retrospectively registered on 13 June 2016. Trial sponsor: University of Bath. Protocol Version 1.5.
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Dickens CM, Bollen J, Trick L, Llewellyn D (2017). The effects of acute inflammation on cognitive functioning and emotional processing in humans: a systematic review of experimental studies. Journal of Psychosomatic Research
Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA (2014). A systematic review of measures of self-reported adherence to unsupervised home-based rehabilitation exercise programmes, and their psychometric properties.
BMJ Open,
4(6).
Abstract:
A systematic review of measures of self-reported adherence to unsupervised home-based rehabilitation exercise programmes, and their psychometric properties.
Adherence is an important factor contributing to the effectiveness of exercise-based rehabilitation. However, there appears to be a lack of reliable, validated measures to assess self-reported adherence to prescribed but unsupervised home-based rehabilitation exercises.
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