Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.
Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.
Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.
Carers of people with non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) face unique challenges. Yet, little evidence-based support and guidance are available for this population. To address this gap in services, we have developed a novel, web-based educational programme: the Better Living with Non-memory-led Dementia programme (BELIDE). BELIDE was co-designed with people with lived experience of non-memory-led dementia and a previous pilot study confirmed its feasibility as an online intervention. This protocol outlines the randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of BELIDE.
This is a parallel-group, single-blind, RCT of 238 unpaid caregivers of people diagnosed with PCA, PPA or bvFTD recruited internationally among members of the UK-based organisation Rare Dementia Support. The intervention (BELIDE programme) consists of six structured online educational modules tailored to each phenotype, a virtual onboarding session, real-life practice tasks and up to two follow-up facilitation sessions. The group receiving the intervention will be given access to the programme, while the control group will receive treatment as usual and be placed on a wait-list to receive access to the programme once they complete their participation in the trial. The allocation ratio will be 1:1 stratified by dementia diagnosis and gender. The primary outcome is reduction in caregiver depressive symptoms. Secondary outcomes include stress, anxiety, self-efficacy, quality of life and caregiver-patient relationship quality. Data will be collected online via Qualtrics surveys at baseline, 8 weeks and 6 months post-randomisation. A mixed-method process evaluation with a subgroup of intervention participants will explore barriers and facilitators for engagement. A health economics evaluation will also be conducted to assess cost-effectiveness. If effective, this programme could improve access to caregiver support for non-memory-led dementias by providing scalable, tailored education.
Ethical approval has been granted by University College London Research Ethics Committee (8545/007). The results will be disseminated via peer-reviewed publications, conferences, stakeholder events and open-access resources.
This trial has been registered prospectively on the Clinical Trials registry, first posted on 5 February 2024 under registration number NCT06241287.
Spinal manipulative therapy (SMT) is a common manual therapy intervention provided by healthcare providers for patients with low back pain (LBP). Responses to SMT are influenced by interactions between the patient and provider. Contextual factors may be specific to the patient, provider, patient-provider relationship or environment in which treatment is provided, with all capable of influencing clinical outcomes. The overall goal of this study is to gain a deeper understanding of contextual factors associated with manual therapy utilisation, perception and outcomes, from both patient and provider perspectives. A better understanding of modifiable contextual factors will inform future studies testing the impact on how SMT is delivered to patients influences clinical outcomes that could potentially advance the clinical science of manual therapy.
A prospective, single-arm study design with follow-up measures assessed up to 26 weeks after initiation of physical therapy for LBP will be used to assess relationships between physical therapy clinical outcomes and contextual factors related to the patient (preference, expectation, pain beliefs, pain associated distress and prior manual therapy experiences), the provider (equipoise, expectation, pain beliefs and clinical experience) and the interaction between the two (therapeutic alliance). Multimodal treatment approach of SMT (required during initial three treatment sessions within a 2week period), exercise and education supported by recent clinical practice guidelines will be encouraged for this study.
Ethics approval for the study was obtained from the University of Florida Institutional Review Board. Informed consent is required for physical therapist and patient participant enrolment in this project. The results of this study will be disseminated at professional scientific conferences and submitted for publication in peer-reviewed journals. Reference or approval number: IRB#: IRB202301700
To estimate the prevalence of dementia and mild cognitive impairment (MCI) in the older prisoner population in England and Wales and to establish risk of harm to self and others, activity of daily living needs and social networks of prisoners with likely MCI and dementia.
We screened 869 older prisoners (aged 50 years and older) using the Montreal Cognitive Assessment (MoCA). Participants testing positive on the MoCA (≤23) were interviewed using the Addenbrooke’s Cognitive Examination, Third Revision (ACE-III) and a range of standardised assessments were used to assess risks of externalised violence and of self-harm; activities of daily living needs; mental health needs; history and symptoms of brain injury (if applicable) and social networks.
The sample was drawn randomly from women’s prisons (n=10) and a representative range of adult men’s prisons (n=11) across England and Wales.
Participants were aged 50 or over and resident in one of the participating prison establishments on the study’s census day.
ACE-III.
We recruited 596 men and 273 women prisoners. Across the whole sample of older prisoners, the prevalence of dementia was 7.0% (95% CI 5.5%, 8.9%) (when weighted for sex and age), with the highest prevalence found among prisoners aged 70 years and older at 11.8% (95% CI 8.0%, 17.1%). The prevalence of dementia for men was 7.0% (95% CI 5.2%, 9.4%) and for women was 6.0% (95% CI 3.8%, 9.5%). Only two individuals (3%) who screened positively on the MoCA had a diagnosis of dementia in their prison healthcare notes, suggesting current under-recognition. The prevalence of MCI was 0.8% (95% CI 0.4% to 1.7%, weighted by age). Of those who screened positively on the MoCA, 32 (46%) participants had a high or very high risk of harm to self or others, and 70 (35%) had no friends with whom they could talk to about private matters or to call on for help (n=35, 50%).
Approximately 1020 older adults living in prison have symptoms of likely dementia, and service provision for this group is inadequate.
Engaging people in advance care planning is a challenging systemic problem that requires a social innovation approach and a conceptual framework to guide behavioural and social change efforts.
To identify stakeholders' perspectives on barriers to advance care planning engagement, options for overcoming these barriers, and user needs. The findings will inform the design of a health behaviour change intervention for engaging older adults (50+) in advance care planning.
To advance co-production and intervention design goals, the study used collective intelligence and scenario-based design methods.
Following a systematic stakeholder analysis, 22 participants were recruited to three online collective intelligence sessions. The socioecological perspective informed framing of integrated findings and specifying factors at the individual, interpersonal, service, and system levels.
Identified barriers (n = 109) were grouped into seven categories: (i) Psychological, (ii) Advance Care Planning Literacy, (iii) Interpersonal and Interprofessional, (iv) Service-Related, (v) Resources and Supports, (vi) Advance Care Planning Process and Methods, (vii) Cultural and Societal. Stakeholders generated 222 options for overcoming these barriers and specified 230 service user needs. The need to change perceptions of advance care planning, increase psychological readiness, and target advance care planning literacy was highlighted (individual-level). Timely, focused, and meaningful interaction between the key ACP actors must be facilitated using creative strategies (interpersonal-level). Need- and value-based services, including high quality resources, support systems, and infrastructure, should be co-designed (service-level). Cultural and societal transformation is required (system-level).
Findings integration offered insight into the complexity of the design context and problem situation and identified directions for context-specific advance care planning intervention development. The use of design thinking methodologies is recommended for the next phase of complex intervention development.
The study presents a roadmap of actions required from policy-makers, practitioners, and researchers to ensure the design of adequate advance care planning interventions.
Quality of reporting was assured by adherence to Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines (International Journal for Quality in Health Care, 19, 2007, 349).
Patient and public representatives participated in the collective intelligence sessions. Members of the All Ireland Institute of Hospice and Palliative Care Voices4Care facilitated that process. Findings from the first CI session (involving patients and caregivers) informed the content, format, and methods used in subsequent CI sessions.