Effect of Online Support and Patient Empowerment on Functional Ability and Well-being in Older Adults: a Pilot Study
Phase: NA
Conditions: Frailty, Sarcopenia, Aging
Sponsor: Aberystwyth University

 
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Brief Title: 
FrAilty Care and wEll-funcTion in 
Community Dwelling Older Adults 
(FACET) 
Official Title: 
Effect of Online Support and Patient 
Empowerment on Functional Ability and 
Well-being in Older Adults: a Pilot Study 
 
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Date of document: 28-3-2018 
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Uploaded to Clinicaltrials.gov: 19-9-2018 
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Method  
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Participants 
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Forty older adults (n-female: 6, n-male: 10, age: xx years, height: xx m, mass: xx kg), residing in the 
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community and recruited via convenience sampling, participated in the study. Participants were 
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excluded if they had moderate/severe dementia at baseline (defined as Mini Mental State 
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Examination < 23), severe, disabling stroke at baseline within the previous 6 months (defined as new 
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or previous stroke with Barthel Index < 9), or a recent (< 3 months prior randomisation) myocardial 
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infarction, or unstable angina. In addition, participants were excluded if they were currently 
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undergoing treatment that includes exercise and diet advice by health professionals and were referred 
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at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation) 
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within the previous 6 months. The study received ethical approval from the University ethics 
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committee and all participants were made aware of the nature of the study and their right to withdraw 
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at any time, before providing written informed consent. All aspects of the study were conducted in 
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accordance with the Declaration of Helsinki. 
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Procedures 
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The trial used a parallel-group design with four intervention arms in a two-by-two factorial design. 
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Arms were based on the factors of ‘consultation type’ and ‘intervention support’ and consisted of 
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professional led consultation with online support (PLOS), professional led consultation without online 
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support (PLNS), participant empowered consultation with online support (PEOS) and participant 
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empowered consultation without online support (PENS). Participants were randomly allocated to a 
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group based on minimization for frailty status, age and gender.   
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Participants attended 2 visits prior to the intervention and 1 visits following the intervention. Various 
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functional ability assessments and health related questionnaires were completed prior to the trial 
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during visit 1 and 2 and repeated after 12-14 weeks during visit 3. During the second visit, participants 
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received a consultation with advice on making lifestyle changes to promote healthy ageing. Between 
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the first visit and second visit and a week before the third visit, participants collected 3 morning void 
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urine samples at home for the determination of their nutritional status.  
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For PLOS and PLNS, the consultation was led by the professional and lifestyle recommendations were 
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based on ViviFrail recommendations and personal experience. In contrast, during PEOS and PENS, the 
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consultation was led by the participant, and started with the questions ‘What matters to you’, and 
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‘What are your goals’. The professional based the lifestyle recommendations based on these 
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responses.  
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For PLOS and PEOS, the 12-week intervention included access to an online monitoring platform. The 
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online platform provided the lifestyle recommendations and consisted of a diary of activities, 
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examples of exercises, general advice and instructions for monitoring and self-assessment.  For PLNS 
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and PENS, there was no access to the online monitoring platform, and lifestyle recommendations were 
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provided on paper to the participant. 
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The consultation was based on the physical ability assessment, risk of falling, and completed 
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questionnaires. Behaviour change advice as part of the lifestyle recommendations were derived from 
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the COM-B model, which assumes that behaviour (B) is determined by capability (C), Opportunity (O) 
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and motivation (M). The capability was offered as feedback from the physical ability assessment and 
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the motivation was assessed with the ‘stages of change ladder’.  The opportunities were in the form 
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of personalized and individually tailored recommendations. Altogether, SMART goal setting and 
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implementation intentions formed the methods of the lifestyle recommendations.  The lifestyle 
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recommendations made were recorded and included characteristics of type of exercises included 
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(balance, strength, flexibility, multi-component, equipment used, nutrition, physical activity tasks), 
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identified goals and action plans (frequency, duration, etc.).  
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Functional ability assessments performed prior and following the intervention consisted of the Short 
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Physical Performance Battery (SPPB), timed-up-and-go (TUG), grip strength, usual walking speed, the 
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6 Minute Walk Test (6MWT),  the sematic fluency test and body composition analysis. The SPPB 
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consists of a scoring system based on the ability to complete 10 seconds of narrow, semi-tandem and 
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tandem stance position while standing upright, the time taken to complete 5 chair rises at maximum 
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speed, and usual walking speed. The TUG consists of the time taken using an accelerometer (G-Walk) 
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to get up from a chair, walk around a cone 3 meters away and return to sit down and is performed at 
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the participant’s usual and comfortable speed. Grip strength was assessed as the maximal value 
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obtained from three attempts with each hand using a dynamometer (Takei). Usual walking speed was 
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determined over a distance of 8 meters, with timing gates placed 4 meters interspaced in the middle 
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of the path. Spatio-temporal variables were derived from an accelerometer (G-walk) and consisted of 
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stance duration, swing phase duration, step length and propulsion of right and left leg. The 6MWT 
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consists of walking the further distance possible in 6 minutes around 2 cones places 10 meters apart. 
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The SFT consists of the ability to mention as many words starting with a particular letter in one minute. 
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Body composition analysis  and bone mineral density assessment of the hip and spine was performed 
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using whole-body DXA scanning (Hologic) to determine appendicular lean mass and body fat 
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percentage, and body impedance analysis (BodyStat) to determine hydration status.  
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Health related questionnaires consisted of the Lawton-Brody and Barthel index to assess the level of 
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abilities performed during daily living.  Frailty was assessed using the FRAIL scale, the Frailty Trait scale 
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and the frailty phenotype model. The frailty phenotype evaluation was derived from the usual walking 
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speed, grip strength, a physical activity questionnaire and two questions related to the presence of 
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unintentional weight loss and exhaustion.  Physical activity levels were assessed with the CHAMPS. 
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Well-being and quality of life were assessed with the WEMWBS, the SF-36 and EuroEQ-5d5L. 
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Healthcare Resource Use was assessed during the 12-week intervention. 
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Nutritional status was assessed based on urine metabolomics, the Mini-Nutritional Assessment, the 
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SNAQ and diet quality assessment. Urine was collected at home, using validated urine collection 
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techniques to store and transport urine samples. Urine was collected at the 2nd and 3rd visit and stored 
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in -80° until further analysis. Dried blood spot samples were collected at home using a Whatman 
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Protein Saver Card to determine lipid levels. During the first visit, a finger prick blood spot sample was 
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to determine Hba1C levels as an indicator of diabetes status, and assess LDL, HDL and total cholesterol.   
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Data analysis 
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All scores are standard derived from the tests itself, and data analyses processes have been published 
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previously. Standard Operating Procedures are available upon request. 
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Statistical Analysis 
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Evaluation of the pilot consisted of the number of participants refusing to be allocated to their original 
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group. If refused, participants were offered the alternative group (‘cross-over’), but excluded from 
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statistical analysis. Intervention recruitment, adherence (online platform usage, self-monitoring 
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frequency, usage of support materials provided) and retention were considered sufficient if: 
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with 3 participants per week (and relative to those  screened, the consent rate taken into 
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account), 
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adherence to the intervention program exceeding 70% and  
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95% retained at follow up, respectively.  
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The lifestyle recommendations made were recorded for subsequent qualitative analyses and 
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quantification of type of exercises included (balance, strength, flexibility, multi-component, 
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equipment used, nutrition, physical activity tasks) as part of the pilot study evaluation.  
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Adverse event occurrence will be recorded. Protocol evaluation will consider time needed for the 
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assessment and questionnaires and the consultation, support time needed for online monitoring and 
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engagement during the intervention, to enable appropriate costing for future trials and revise 
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accordingly.  Participant characteristics (frailty, disability) will be summarized to determine future 
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recruitment criteria. 
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 Estimated sample size and confidence intervals will be initially based on primary outcome measures: 
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Well-being (WEMWBS), Grip strength, Walking speed and SPPB. From those, but possible the 
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secondary outcome measures, a primary outcome variable would be determined for the future 
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randomized control trial. 
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Secondary outcome measures consist of:  
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Functional ability performance, including timed-up-and-go, chair-stand test, balance, 
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flexibility, 6MWT.  
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Dietary analyses  
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Healthcare Resource Use (i.e. hospital visits, GP appointments) assessed using a Healthcare 
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Resource Use questionnaire at baseline and 12 weeks, to assess potential follow up impact 
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due to inadvertent worrying of participants. 
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Qualitative feedback from assessors and participants about FACET 
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Quality of life derived from the Short Form 36 item health questionnaire (SF36) at baseline 
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and 12 weeks, including the Physical Component Summary (PCS)  
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