Planning and optimising a digital intervention to protect older adults' cognitive health.

BackgroundBy 2050, worldwide dementia prevalence is expected to triple. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the theory-, evidence- and person-based development of 'Active Brains': a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults.MethodsDuring the initial planning phase, scoping reviews, consultation with PPI contributors and expert co-investigators and behavioural analysis collated and recorded evidence that was triangulated to inform provisional 'guiding principles' and an intervention logic model. The following optimisation phase involved qualitative think aloud and semi-structured interviews with 52 older adults with higher and lower cognitive performance scores. Data were analysed thematically and informed changes and additions to guiding principles, the behavioural analysis and the logic model which, in turn, informed changes to intervention content.ResultsScoping reviews and qualitative interviews suggested that the same intervention content may be suitable for individuals with higher and lower cognitive performance. Qualitative findings revealed that maintaining independence and enjoyment motivated engagement in intervention-targeted behaviours, whereas managing ill health was a potential barrier. Social support for engaging in such activities could provide motivation, but was not desirable for all. These findings informed development of intervention content and functionality that appeared highly acceptable amongst a sample of target users.ConclusionsA digitally delivered intervention with minimal support appears acceptable and potentially engaging to older adults with higher and lower levels of cognitive performance. As well as informing our own intervention development, insights obtained through this process may be useful for others working with, and developing interventions for, older adults and/or those with cognitive impairment

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. OBJECTIVE: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. METHODS: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). RESULTS: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. CONCLUSIONS: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18929

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors

Background: Many cancer survivors following primary treatment have prolonged poor quality of life.Aim: To determine the effectiveness of a bespoke digital intervention to support cancer survivors.Design: Pragmatic parallel open randomised trial.Setting: UK general practices.Methods: People having finished primary treatment (&lt;= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score &lt;85, were randomised by online software to: 1) detailed ‘generic’ digital NHS support (‘LiveWell’;n=906), 2) a bespoke complex digital intervention (‘Renewed’;n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) ‘Renewed-with-support’ (n=903): ‘Renewed’ with additional brief email and telephone support. Results: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n’s respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified.Conclusion: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global healthenablement and symptom management, with substantially lower NHS costs.<br/

A randomised controlled trial of a digital intervention (renewed) to support symptom management, wellbeing and quality of life in cancer survivors

Background: Many cancer survivors following primary treatment have prolonged poor quality of life. Aim: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. Design: Pragmatic parallel open randomised trial. Setting: UK general practices. Methods: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed ‘generic’ digital NHS support (‘LiveWell’;n=906), 2) a bespoke complex digital intervention (‘Renewed’;n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) ‘Renewed-with-support’ (n=903): ‘Renewed’ with additional brief email and telephone support. Results: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n’s respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. Conclusion: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs

An investigation into cortical activity associated with robotic upper limb rehabilitation after stroke

Background: Many stroke survivors are left with upper limb impairments that affect their ability to carry out functional tasks. Using neuroimaging and electrophysiological technology, advances have been made in understanding brain function and reorganisation after stroke. These findings provide valuable insights and may provide the key to more effective rehabilitation practices. Objectives: This research aimed to improve understanding of cortical function recovery after stroke, as measured by electroencephalography (EEG) during a reaching movement, before and following robotic upper limb rehabilitation. In particular, the study looked for event-related changes in EEG waves commonly referred to as event-related desynchronisation (ERD) and event-related synchronisation (ERS), which are measured in the frequency domain. Methods: EEG was recorded over the sensorimotor cortex during a reaching movement with all participants using a customised experimental setup developed for this study. Four studies were carried out: 1) a feasibility study tested data collection methods with four participants, 2) test-retest variability of ERD/ERS measures over three sessions was determined with five healthy participants, 3) averaged ERD/ERS measures were examined in a group of ten healthy participants, 4) ERD/ERS measures of six stroke participants who underwent ten sessions of robotic upper limb rehabilitation over two weeks were examined, and changes following rehabilitation were compared to changes in measures of upper limb impairment (Fugl-Meyer Assessment) and function (Action Research Arm Test). Results: Results from the stroke participant study show that 1) two participants presented with reduced alpha ERD over the ipsilateral hemisphere, three participants had a predominant alpha and/or beta ERD over the ipsilateral hemisphere, and beta ERS following movement was predominantly found to occur over the ipsilateral hemisphere for four participants, and 2) two participants showed changes in ERD/ERS measures that could be attributed to the effects of rehabilitation, with associations made with measures of upper limb impairment and function. These changes related to hemispheric lateralisation of alpha ERD, as demonstrated by a decrease of excessive contralateral predominance (when compared to healthy participants) as well as to a hypothesised normalisation of interhemispheric inhibitory mechanisms demonstrated by a decrease in abnormal alpha and beta ERS during movement. Conclusions: Abnormal ERD/ERS measures of hemispheric laterality were a recurrent feature of stroke participants, with some changes that could be attributed to the effects of rehabilitation, indicating that measures of ERD/ERS during reaching using this experimental setup could be used to assess and monitor cortical activity recovery after stroke. Further work is however proposed to determine the responsiveness of the methods used, as improved motor function was not always accompanied by changes in measures of ERD/ERS

Data for &#39;An investigation into cortical activity associated with robotic upper limb rehabilitation after stroke&#39;

Research Data for the Thesis &#39;An investigation into cortical activity associated with robotic upper limb rehabilitation after stroke&#39; by Sebastien Pollet. Awarded 2018</span

Impact of a web-supported programme of Constraint Induced Therapy following stroke (LifeCIT)

Background: upper extremity (UE) movement is often compromised following a stroke. Constraint Induced Therapy (CIT) is an evidence-based intensive intervention (1) which involves people with stoke practicing activites with their affected hand whilst wearing a mitt on their other hand, but it relies on intensive therapy. A study trialling CIT in a community setting without a therapist present found key barriers to be lack of motivation to wear the mitt and comply with the exercise programme (2). A web supported CIT system (LifeCIT) for UE stroke rehabilitation was developed to address this barrier. Objective: to evaluate the impact of using LifeCIT for UE stroke rehabilitation compared to usual care in subacute/chronic stroke patients at home.Methods: subacute/chronic stroke patients were randomized into a three week intervention consisting of LifeCIT or control groups. UE impairment and function were assessed with the Motor activity log (MAL), Fugl-Meyer (FMA-UE) and Wolf Motor Function Test (WMFT) pre and post intervention and at a six month follow-up. Results: sixteen patients completed the trial. Between group differences, favouring the LifeCIT group in MAL (AOU and QOU) and WMFT (FAS) were identified post intervention (ANCOVA) and controlled for baseline clinical scores, Orpington score and Sub-acute/chronic. Mean improvement in the LifeCIT group MALfrom baseline to post treatment (1.02 AOU and QOU) and at six months (0.6 AOU and QOU) was above the minimally clinically important difference (MCID) for the MAL (MCID = 0.5) Improvement in the LifeCIT group WMFT (FAS) met MCID from baseline to post intervention (0.35) and at six months (0.3) FAS MCID=0.2 - 0.4. Interview data confirmed positive acceptance of LifeCIT. Conclusion: use of LifeCIT in the community improved UE function in subacute/chronic stroke patients following a three week intervention and at a six month follow-up, suggesting a larger scale study should be run. References(1) Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D et al. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. Journal of the American Medical Association 2006; 296(17):2095-2104.(2) Burns A, Burridge J.H., Pickering R.M. Does the use of a constraint mitten to encourage use of the hemiplegic upper limb improve arm function in adults with subacute stroke? Clin Rehabil 2007; 21:895-904.Supported by the National Institute for Health Research (NIHR) Research for Patient Benefit (RFPB) <br/