FrAilty Care and wEll-funcTion in Community Dwelling Older Adults

Participants will be individually randomised using randomisation service on a 1:1 allocation ratio to either group. There will be 4 groups, with differences in the consultation design and online support available.

Participant assessments consists of questionnaires and physical tasks completed during two visits at the university facilities. During the second visit, a one-hour consultation with a health care professional will take place to develop a twelve-week action plan to promote a healthier lifestyle.

Frailty status will be defined from the Fried frailty phenotype criteria. Exercise status will be based on current physical activity levels and the Short Physical Performance Battery score derived from the chair-stands, gait speed and balance assessments.

Participants in the experimental group will receive the assessment, and the consultation will aim to promote to empower them, plus access to the online support platform, termed 'FACET'.

Participants in the empowerment groups are provided with a structured booklet prior to the consultation to help the participant actively contribute to their own intervention programme, whereas in the other groups,the professional will lead the consultation.

Participants in the online support groups are provided with FACET, which will provide a diary of recommended activities to do, assessments to complete, as well as information about healthy lifestyles, diet and physical activity recommendations. Details on the recommended exercises and diet will be provided (including demonstrations and examples, also sourced from reputable websites) via FACET and will enable the participant to engage with them. The exercises require no special equipment and can be performed without professional supervision. Participants will be able to monitor themselves regularly and progress or amend recommendations to tailor their needs. Progress will also be monitored by the initial assessors and these can also amend the recommendations based on participant feedback. In short, FACET enables the participants in these groups to engage with their own intervention, amend it and set their own priorities, goals and targets, emphasising prudent health care principles.

Participants in all groups are followed up after 12 weeks. Assessments will be completed face-to-face at the facilities, or at home, dependent upon the participant's needs.

• Consultation (Behavioral), also known as Diet, exercise and physical activity advice: The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
• Online Support (Behavioral): The participant will have access to an online platform 'FACET', to monitor themselves periodically, obtain feedback about their functional ability, receive recommended diet, exercise and physical activity interventions and record the adherence to any intervention.
• Empowered (Behavioral): The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.

Primary outcomes

• Pilot Evaluation - Percentage of Participants Retained at Follow up [3 Months]: Percentage of participants returned at follow up, reflects the ability to recruit and retain participants. Recruitment took place over a period of 3 months, to recruit 42 participants, with a recruitment rate of 14 participants per month.
• Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [3 months]: Scored with the total score ( range of 14-70), and higher scores reflecting better well-being.
• Short Physical Performance Battery [3 months]: Consists of Walking speed, balance, and chair stand test performance. Scored based on a score of 0-4 on each test, which are then added. A total maximum score of 12 reflecting good physical performance and thus higher scores indicate better outcome..

Secondary outcomes

• SNAQ -Dietary Analysis [3 months]: The SNAQ was used to provide a single outcome variable for this. Was originally: Food diary and urine metabolomics for the ingestion of food components (meats, fish, legumes and fruits), with emphasis on the quantification of the total protein intake. SNAQ: Simplified Nutritional Appetite Questionnaire. Scale from 5-25, with higher scores indicating better outcome
• Timed-up-and go [3 months]: The ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again.
• Quality of Life SF36 [3 months]: the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life.
• Grip Strength [3 months]: Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength

Other outcomes

• Six Minute Walking Performance [3 months]: Quantifies the distance able to walk during six minutes

Sex: All, ages: 60 Years to 110 Years, accepts healthy volunteers

Inclusion Criteria:

* Age 60 years and over
* Willingness to give informed consent, to be randomized to one of the study groups, and comply with all study requirements
* Community dwelling, assisted living conditions or care home residents.
* Ability to walk 10 m independently, or with support if using a cane or walker.
* Ability to understand instructions regarding the use of the technology and execution of the exercise program.

Exclusion Criteria:

* Moderate/severe dementia at baseline (defined as Mini Mental State Examination < 23),
* Severe, disabling stroke at baseline within the previous 6 months (defined as new or previous stroke with Barthel Index < 9),
* Recent (< 3 months prior randomisation) myocardial infarction, or unstable angina.
* Currently undergoing treatment that includes exercise and diet advice by health professionals
* Referred at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation) within the previous 6 months.
* Currently taking part in another study or taken part in an intervention study in the previous six months

Participant flow

Outcome results

• Pilot Evaluation - Percentage of Participants Retained at Follow up (Primary), Count of participants, Participants: Professional Led With Online Support 10; Professional Led Without Online Support 10; Patient Empowered With Online Support 9; Patient Empowered Without Online Support 11
• Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Primary), Mean, score on a scale: Professional Led With Online Support 55 +/- 7; Professional Led Without Online Support 54 +/- 8; Patient Empowered With Online Support 53 +/- 7; Patient Empowered Without Online Support 50 +/- 11
• Short Physical Performance Battery (Primary), Mean, score on a scale: Professional Led With Online Support 11.4 +/- 1.0; Professional Led Without Online Support 10.3 +/- 2.5; Patient Empowered With Online Support 10.4 +/- 3.0; Patient Empowered Without Online Support 11.1 +/- 1.0
• SNAQ -Dietary Analysis (Secondary), Mean, units on a scale: Professional Led With Online Support 16 +/- 2.1; Professional Led Without Online Support 15.6 +/- 2.3; Patient Empowered With Online Support 17.4 +/- 1.1; Patient Empowered Without Online Support 16.4 +/- 2.4
• Timed-up-and go (Secondary), Mean, seconds: Professional Led With Online Support 7.11 +/- 1.56; Professional Led Without Online Support 10.55 +/- 7.04; Patient Empowered With Online Support 10.00 +/- 9.31; Patient Empowered Without Online Support 8.46 +/- 2.29
• Quality of Life SF36 (Secondary), Mean, units on a scale: Professional Led With Online Support 72 +/- 21; Professional Led Without Online Support 69 +/- 19; Patient Empowered With Online Support 64 +/- 18; Patient Empowered Without Online Support 60 +/- 19
• Grip Strength (Secondary), Mean, kilogram: Professional Led With Online Support 30.0 +/- 3.7; Professional Led Without Online Support 24.7 +/- 7.6; Patient Empowered With Online Support 28.0 +/- 9.4; Patient Empowered Without Online Support 27.4 +/- 8.1
• Six Minute Walking Performance (Other pre specified), Mean, meter: Professional Led With Online Support 480 +/- 89; Professional Led Without Online Support 396 +/- 102; Patient Empowered With Online Support 407 +/- 163; Patient Empowered Without Online Support 439 +/- 102

Adverse events

Time frame: Three months, the duration of the intervention and the time between baseline and follow up assessment

Serious adverse events by term

Other adverse events by term

Limitations and caveats: The incomplete data comprised questionnaires that were completed at home and returned subsequently. Adverse events were not recorded by 13 out of 40 participants, but the documentation did not contain a confirmation box to indicate that 'no adverse events' took place. Thus, although it was assumed that these individuals had no adverse events, it is an assumption, based on non-reporting of adverse events and conversations, but not verified in writing.

• Results publication: Valdes-Aragones M, Perez-Rodriguez R, Carnicero JA, Moreno-Sanchez PA, Oviedo-Briones M, Villalba-Mora E, Abizanda-Soler P, Rodriguez-Manas L. Effects of Monitoring Frailty Through a Mobile/Web-Based Application and a Sensor Kit to Prevent Functional Decline in Frail and Prefrail Older Adults: FACET (Frailty Care and Well Function) Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Oct 22;26:e58312. doi: 10.2196/58312. PMID 39436684

• Study Protocol and Statistical Analysis Plan (PDF, 2018-03-28)

• John Draper, PhD, Study director, Aberystwyth University