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FrailtyFACETNCT03707145

FrAilty Care and wEll-funcTion in Community Dwelling Older Adults

A study testing Consultation, Online Support and Empowered in people with Frailty and Sarcopenia, run by Aberystwyth University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Frailty, Sarcopenia, Aging
What is being tested?
Consultation, Online Support and Empowered
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited Kingdom
Study dates
30 Mar 2018to 30 Jul 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Aberystwyth University

    Aberystwyth, Ceredigion, SY23 3FD

Other trials in United Kingdom

About this study

Official title: Effect of Online Support and Patient Empowerment on Functional Ability and Well-being in Older Adults: a Pilot Study

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.

Being tested
Consultation, Online Support, Empowered
Keywords
well-being, exercise, physical activity, nutrition, gait
Medical subject headings
Frailty, Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConsultationBehavioural

    Also called 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 SupportBehavioural

    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.

  • EmpoweredBehavioural

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

Study groups in NCT03707145
Study groupRoleWhat they receive
Professional led with online supportActive comparatorThe 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.
Receives: Behavioral: Consultation; Behavioral: Online Support
Professional led without online supportActive comparatorThe 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.
Receives: Behavioral: Consultation
Patient empowered with online supportExperimentalThe 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.
Receives: Behavioral: Consultation; Behavioral: Online Support; Behavioral: Empowered
Patient empowered without online supportActive comparatorThe 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.
Receives: Behavioral: Consultation; Behavioral: Empowered

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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..

    Measured: 3 months

Secondary outcomes (4)

  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

    Measured: 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.

    Measured: 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.

    Measured: 3 months

  4. Grip Strength

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start30 Mar 2018
  3. Primary completion24 Dec 2018
  4. Study completion30 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation
Masking
Single blind
Who is masked
Participant
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03707145
Sponsor's protocol ID
9526
Acronym
FACET
Status last verified
Jul 2024
First submitted
6 Sep 2018
Last updated
21 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Consultation, Online Support and Empowered in people with Frailty and Sarcopenia, run by Aberystwyth University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pilot Evaluation - Percentage of Participants Retained at Follow up (time frame: 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03707145, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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