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FrAilty Care and wEll-funcTion in Community Dwelling Older Adults (FACET)

Primary Purpose

Frailty, Sarcopenia, Aging

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Consultation
Online Support
Empowered
Sponsored by
Aberystwyth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring well-being, exercise, physical activity, nutrition, gait

Eligibility Criteria

60 Years - 110 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Aberystwyth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

Professional led with online support

Professional led without online support

Patient empowered with online support

Patient empowered without online support

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Pilot evaluation - Percentage of participants retained at follow up
Percentage of participants returned at follow up, reflects the ability to recruit and retain participants.
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Scored with the total score ( range of 0-70), and higher scores reflecting better well-being.
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, with a total maximum score of 12 reflecting good physical performance.

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2018
Last Updated
October 13, 2018
Sponsor
Aberystwyth University
Collaborators
EIT Health
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1. Study Identification

Unique Protocol Identification Number
NCT03707145
Brief Title
FrAilty Care and wEll-funcTion in Community Dwelling Older Adults
Acronym
FACET
Official Title
Effect of Online Support and Patient Empowerment on Functional Ability and Well-being in Older Adults: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
December 24, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aberystwyth University
Collaborators
EIT Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Sarcopenia, Aging
Keywords
well-being, exercise, physical activity, nutrition, gait

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation
Masking
Participant
Masking Description
The participant is unaware of the other groups details. Assessor and investigator are not blinded due to the need for providing information to the participant about their group allocation in this pilot project
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Professional led with online support
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Professional led without online support
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patient empowered with online support
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient empowered without online support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Consultation
Other Intervention Name(s)
Diet, exercise and physical activity advice
Intervention Description
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Intervention Type
Behavioral
Intervention Name(s)
Online Support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empowered
Intervention Description
The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.
Primary Outcome Measure Information:
Title
Pilot evaluation - Percentage of participants retained at follow up
Description
Percentage of participants returned at follow up, reflects the ability to recruit and retain participants.
Time Frame
3 Months
Title
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Description
Scored with the total score ( range of 0-70), and higher scores reflecting better well-being.
Time Frame
3 months
Title
Short Physical Performance Battery
Description
Consists of Walking speed, balance, and chair stand test performance. Scored based on a score of 0-4 on each test, with a total maximum score of 12 reflecting good physical performance.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Dietary analysis
Description
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.
Time Frame
3 months
Title
Timed-up-and go
Description
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
Title
Quality of Life SF36
Description
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
Title
Grip strength
Description
Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Six minute walking performance
Description
Quantifies the distance able to walk during six minutes
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Draper, PhD
Organizational Affiliation
Aberystwyth University
Official's Role
Study Director
Facility Information:
Facility Name
Aberystwyth University
City
Aberystwyth
State/Province
Ceredigion
ZIP/Postal Code
SY23 3FD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://waru.org.uk/cms/projects/facet/
Description
Project website

Learn more about this trial

FrAilty Care and wEll-funcTion in Community Dwelling Older Adults

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