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CompletedNCT03707145FACETUpdated Oct 21, 2024Results posted

FrAilty Care and wEll-funcTion in Community Dwelling Older Adults

An interventional study of Consultation and Online Support in Frailty, Sarcopenia and Aging, sponsored by Aberystwyth University. Completed at 1 site in United Kingdom. Open to participants aged 60 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.

Sponsored by Aberystwyth University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2018, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
60 Years to 110 Years
Sex
All
01

Study summary

This study is looking at whether older people could benefit from an online monitoring platform to support their individual ambitions to maintain or improve functional ability. It is hypothesized this will enable the individual 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. All information can be linked back to the health care professional for official support and intervene when a decline is noticed, in order to prevent frailty from developing. The aim of this study is to find out if providing more support and greater empowerment can help older people improve their functional ability by self-monitoring and personalised interventions.

Read the detailed description

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.

02

Conditions studied

  • Frailty
  • Sarcopenia
  • Aging

Keywords

  • well-being
  • exercise
  • physical activity
  • nutrition
  • gait
03

In context

Frailty

1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.

This study's enrollment of 43 is below the median of 80 across 704 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Aberystwyth University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    Professional led with online support

    The consultation is led by the professional and lifestyle recommendations are based on ViviFrail recommendations and personal experience of the professional. The 12-week intervention includes access to an online monitoring platform. The online platform provides the lifestyle recommendations and consists of a diary of activities, examples of exercises, general advice and instructions for monitoring and self-assessment.

    Behavioral: Consultation · Behavioral: Online Support

  • Active comparator
    Professional led without online support

    The consultation is led by the professional and lifestyle recommendations are based on ViviFrail recommendations and personal experience of the professional. There is no access to the online monitoring platform, and lifestyle recommendations were provided on paper to the participant.

    Behavioral: Consultation

  • Experimental
    Patient empowered with online support

    The consultation is led by the participant, and started with the questions 'What matters to you', and 'What are your goals'. The professional based the lifestyle recommendations based on these responses. The 12-week intervention includes access to an online monitoring platform. The online platform provides the lifestyle recommendations and consists of a diary of activities, examples of exercises, general advice and instructions for monitoring and self-assessment.

    Behavioral: Consultation · Behavioral: Online Support · Behavioral: Empowered

  • Active comparator
    Patient empowered without online support

    The consultation is led by the participant, and started with the questions 'What matters to you', and 'What are your goals'. The professional based the lifestyle recommendations based on these responses. There is no access to the online monitoring platform, and lifestyle recommendations were provided on paper to the participant.

    Behavioral: Consultation · Behavioral: Empowered

Interventions

  • BehavioralConsultation

    The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual

    Also known as: Diet, exercise and physical activity advice

  • BehavioralOnline Support

    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.

  • BehavioralEmpowered

    The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.

06

What researchers measure

Primary outcomes

  1. Pilot Evaluation - Percentage of Participants Retained at Follow up

    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.

    Time frame: 3 Months

  2. Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    Scored with the total score ( range of 14-70), and higher scores reflecting better well-being.

    Time frame: 3 months

  3. Short Physical Performance Battery

    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..

    Time frame: 3 months

Secondary outcomes

  1. SNAQ -Dietary Analysis

    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

    Time frame: 3 months

  2. Timed-up-and go

    The ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again.

    Time frame: 3 months

  3. Quality of Life SF36

    the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life.

    Time frame: 3 months

  4. Grip Strength

    Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength

    Time frame: 3 months

Other outcomes

  1. Six Minute Walking Performance

    Quantifies the distance able to walk during six minutes

    Time frame: 3 months

07

Results

Posted Oct 21, 2024
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.

Participant flow

Recruitment was done via invitation of existing database from our Research Unit, word of mouth and local advertising and promotion.

Participant flow — Overall Study
MilestoneProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Started10111011
Completed1010911
Not completed0110
Withdrew: Lost to follow-up0110

Outcome measures

PrimaryPilot Evaluation - Percentage of Participants Retained at Follow up

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.

Time frame:
3 Months
Reported as:
Count of participants · Participants
Pilot Evaluation - Percentage of Participants Retained at Follow up
ParticipantsProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Pilot Evaluation - Percentage of Participants Retained at Follow up1010911
PrimaryWarwick-Edinburgh Mental Well-being Scale (WEMWBS)

Scored with the total score ( range of 14-70), and higher scores reflecting better well-being.

Time frame:
3 months
Reported as:
Mean · score on a scale
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
score on a scaleProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)55 ± 754 ± 853 ± 750 ± 11
Statistical analysis
  • Professional Led With Online Support vs Professional Led Without Online Support vs Patient Empowered With Online Support vs Patient Empowered Without Online Support · Partial eta squared: 0.058
PrimaryShort Physical Performance Battery

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..

Time frame:
3 months
Reported as:
Mean · score on a scale
Short Physical Performance Battery
score on a scaleProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Short Physical Performance Battery11.4 ± 1.010.3 ± 2.510.4 ± 3.011.1 ± 1.0
Statistical analysis
  • Professional Led With Online Support vs Professional Led Without Online Support vs Patient Empowered With Online Support vs Patient Empowered Without Online Support · Partial eta squared: 0.008
SecondarySNAQ -Dietary Analysis

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

Time frame:
3 months
Reported as:
Mean · units on a scale
SNAQ -Dietary Analysis
units on a scaleProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
SNAQ -Dietary Analysis16 ± 2.115.6 ± 2.317.4 ± 1.116.4 ± 2.4
SecondaryTimed-up-and go

The ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again.

Time frame:
3 months
Reported as:
Mean · seconds
Timed-up-and go
secondsProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Timed-up-and go7.11 ± 1.5610.55 ± 7.0410.00 ± 9.318.46 ± 2.29
SecondaryQuality of Life SF36

the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life.

Time frame:
3 months
Reported as:
Mean · units on a scale
Quality of Life SF36
units on a scaleProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Quality of Life SF3672 ± 2169 ± 1964 ± 1860 ± 19
SecondaryGrip Strength

Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength

Time frame:
3 months
Reported as:
Mean · kilogram
Grip Strength
kilogramProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Grip Strength30.0 ± 3.724.7 ± 7.628.0 ± 9.427.4 ± 8.1
Other pre-specifiedSix Minute Walking Performance

Quantifies the distance able to walk during six minutes

Time frame:
3 months
Reported as:
Mean · meter
Six Minute Walking Performance
meterProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Six Minute Walking Performance480 ± 89396 ± 102407 ± 163439 ± 102

Adverse events

Collected over Three months, the duration of the intervention and the time between baseline and follow up assessment. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Professional Led With Online Support0/10 (0%)0/10 (0%)1/10 (10%)
Professional Led Without Online Support0/11 (0%)3/11 (27.3%)3/11 (27.3%)
Patient Empowered With Online Support0/10 (0%)0/10 (0%)1/10 (10%)
Patient Empowered Without Online Support0/11 (0%)3/11 (27.3%)2/11 (18.2%)
Most frequent serious events
Most frequent serious events
EventProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
Hernia operation and complicationsMusculoskeletal and connective tissue disorders0/101/110/100/11
Progressed into disability and houseboundGeneral disorders0/101/110/100/11
Sepsis and bowel abscessGastrointestinal disorders0/100/110/101/11
Hip replacement surgeryMusculoskeletal and connective tissue disorders0/101/110/100/11
Mental ill-health: stressPsychiatric disorders0/100/110/101/11
DiarrhoeaGastrointestinal disorders0/100/110/101/11
Most frequent other events
Most frequent other events
EventProfessional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online Support
PainMusculoskeletal and connective tissue disorders1/101/110/102/11
Muscle InjuryMusculoskeletal and connective tissue disorders0/101/111/100/11
FallGeneral disorders0/101/110/100/11

Baseline characteristics

Two participants removed as part of the analysis as part of the pilot project. One participant was in Patient Empowered with Online Support (lost to follow up), and another one in Professional led without online support (lost to follow up). Another participant was excluded before group allocation due to not meeting the eligibility criteria identified during the pre-enrolment meeting. In total, 43 participants were recruited.

Age, Categorical
Age, Categorical(Participants)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
<=18 years00000
Between 18 and 65 years10113
>=65 years91191039
Age, Continuous
Age, Continuous(years)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
Mean74 ± 681 ± 474 ± 875 ± 676 ± 7
Age, Customized
Age, Customized(Participants)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
60-7020316
70-80643720
80-90274316
Sex: Female, Male
Sex: Female, Male(Participants)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
Female789933
Male33129
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
Count of participants————0
Region of Enrollment
Region of Enrollment(participants)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
United Kingdom1011101142
Warwick and Edinburgh Mental Well-being Scale
Warwick and Edinburgh Mental Well-being Scale(score on a scale)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
Mean58 ± 555 ± 552 ± 547 ± 1253 ± 9
Short Physical Performance Battery
Short Physical Performance Battery(score on a scale)Professional Led With Online SupportProfessional Led Without Online SupportPatient Empowered With Online SupportPatient Empowered Without Online SupportTotal
Mean11.1 ± 1.110.4 ± 1.510.7 ± 1.610.1 ± 1.410.6 ± 1.4

5 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Aberystwyth University
    Aberystwyth, Ceredigion SY23 3FD, United Kingdom
09

References and documents

Publications

  • 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. PubMed 39436684 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 28, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03707145
Lead sponsor
Aberystwyth University
Collaborators
EIT Health
Responsible party
Marco Arkesteijn (Lecturer in Sport and Exercise Biomechanics, Aberystwyth University) — Principal investigator
First posted
Oct 16, 2018
Start date
Mar 30, 2018
Primary completion
Dec 24, 2018
Completion
Jul 30, 2020
Results posted
Oct 21, 2024
Last update
Oct 21, 2024

Study contacts

John Draper, PhD
study director · Aberystwyth University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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