A Digital Human for Delivering a Remote Loneliness and Stress Intervention to At-Risk Younger and Older Adults During the COVID-19 Pandemic: A Randomised Pilot Trial (Preprint)

2021 ◽  
Author(s):  
Kate Loveys ◽  
Mark Sagar ◽  
Isabella Pickering ◽  
Elizabeth Broadbent

BACKGROUND Loneliness is a growing public health issue that has been exacerbated in vulnerable groups during the COVID-19 pandemic. Computer agents are capable of delivering psychological therapies through the internet, however, there is little research on their acceptability to date. OBJECTIVE The objectives of this study were to evaluate: (1) the feasibility and acceptability of a remote loneliness and stress intervention with digital human delivery to at-risk adults; and (2) the feasibility of the trial methods in preparation for a randomised controlled trial. METHODS A parallel, randomised pilot trial with a mixed design was conducted. Participants were adults aged 18–69 years with an underlying medical condition, or aged 70 years or older with a >24 MMSE score (i.e., at greater risk of developing severe COVID-19). Participants took part from their place of residence (20= independent living retirement village, 7= community dwelling, 3= nursing home). Participants were randomly allocated to the intervention or waitlist control group, who received the intervention one week later. The intervention involved completing cognitive behavioural (e.g., psychoeducation on stress awareness, deep breathing) and positive psychology exercises with a digital human facilitator on a website for at least 15-minutes per day over one week. The exercises used evidence-based strategies to improve loneliness, stress, and psychological well-being. Feasibility was evaluated using dropout rates and behavioural observation data. Acceptability was evaluated using behavioural engagement data, the Friendship Questionnaire (adapted), self-report items and qualitative questions. Psychological outcomes were measured to evaluate feasibility of trial methods and included loneliness (UCLA Loneliness Scale), stress (Perceived Stress Scale), COVID-19 distress, well-being (Flourishing Scale), and affect (Scale of Positive and Negative Experiences). RESULTS 30 participants (15 per group) were recruited. Participants were 22 older adults, and 8 younger adults with a health condition. 6 participants dropped out of the study. 24 participants’ data were analysed (12= intervention group; 12= waitlist group). The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently. Slow internet speed reduced intervention feasibility for some participants. Suggestions for improvement included: additional content, tailoring to the population, and changes for the digital human’s design. The intervention and trial methods were less feasible to nursing home residents who required caregiver assistance. CONCLUSIONS The digital human was a feasible and acceptable way of delivering a remote loneliness and stress intervention to at-risk adults during the COVID-19 pandemic. The intervention and trial methods were most feasible for people living independently. Support was found for further testing of digital humans to deliver remote psychological interventions. Findings will inform expansion of intervention content and the design of a randomised controlled trial to evaluate intervention effectiveness. CLINICALTRIAL Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000786998

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e025167 ◽  
Author(s):  
Mark Tarrant ◽  
Mary Carter ◽  
Sarah Gerard Dean ◽  
Rod S Taylor ◽  
Fiona C Warren ◽  
...  

IntroductionThe singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases.Trial registration numberNCT03076736.


2021 ◽  
Author(s):  
Ruth McLaren ◽  
Paul F. Smith ◽  
Sue Lord ◽  
Preet Kamal Kaur ◽  
Yiwen Zheng ◽  
...  

UNSTRUCTURED Background: Reduced mobility and falls are common in older adults. Balance retraining programmes are effective in reducing falls and improving balance and mobility. Noisy galvanic stimulation (nGVS) is a low level electrical stimulation used to reduce the threshold for firing of vestibular neurons via a mechanism of stochastic resonance. We hypothesise that nGVS will enhance the effects of balance retraining in older adults at risk of falls. Methods: This 3- armed randomised controlled trial assesses the feasibility of augmenting balance retraining with nGVS. Community dwelling older adults at risk of falling will be randomly assigned to either an nGVS plus balance programme (nGVS group), sham plus balance programme (sham group) or a no treatment group (Control). Participants will attend the exercise group twice a week for 8 weeks with assessment of balance and gait pre-treatment, post-treatment and at 3-months post-intervention. Primary outcome measures include postural sway, measured by Centre of Pressure (COP) velocity, area and root mean square and gait parameters of speed, step width, step variability and double support time. Spatial memory will also be measured using the Triangle Completion and 4 Mountains Tests. Discussion: This study will evaluate the feasibility of using nGVS alongside balance retraining in older adults at risk of falls and will inform the design of a fully powered randomised controlled trial. Trial registration: This trial has been prospectively registered with the Australia New Zealand Clinical Trials Registry (ACTRN12620001172998) and has a UTN of U1111-1241-2231.


BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027386 ◽  
Author(s):  
Josefine Östh ◽  
Vinod Diwan ◽  
Maria Jirwe ◽  
Vishal Diwan ◽  
Anita Choudhary ◽  
...  

IntroductionDue to ageing populations worldwide, the burden of disability is increasing. It is therefore important to develop interventions that improve healthy ageing, reduce disability onset and enhance life quality. Physical activity can promote healthy ageing and help maintain independence, yet many older adults are inactive. Yoga is a form of physical activity that aims to improve health and may be particularly suitable for older adults. Research indicates positive effects of yoga on several health-related outcomes; however, empirical studies examining the benefits of yoga on well-being among the elderly remain scarce. This study protocol reports the methodology for a 12-week yoga programme aimed to improve health and well-being among physically inactive older adults.Methods and analysisThree group parallel, single-blind randomised controlled trial. Two comparison groups are included: aerobic exercise and a non-active wait-list control. In total, 180 participants aged 65–85 years will be recruited. Assessments will be performed at baseline and postintervention (12-week follow-up). The primary outcome is subjective well-being. Secondary outcomes include physical activity/sedentary behaviour, mobility/fall risk, cognition, depression, anxiety, mood, stress, pain, sleep quality, social support and cardiometabolic risk factors. Data will be analysed using intention-to-treat analyses, with mixed linear modelling.Ethics and disseminationThis study is approved by the Ethical Review Board in Stockholm (2017/1862-31/2). All participants must voluntarily agree to participate and are free to withdraw from the study at any point. Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences. A summary of key results will be publicly available through newspaper articles.Trial registration numberDRKS00015093, U1111-1217-4248


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