Publications by year
In Press
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 Full text.
2021
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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2020
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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2018
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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2017
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 Full text.
2014
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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