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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707145
Recruitment Status : Unknown
Verified October 2018 by Marco Arkesteijn, Aberystwyth University.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
EIT Health
Information provided by (Responsible Party):
Marco Arkesteijn, Aberystwyth University

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.

Condition or disease Intervention/treatment Phase
Frailty Sarcopenia Aging Behavioral: Consultation Behavioral: Online Support Behavioral: Empowered Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation
Masking: Single (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
Primary Purpose: Prevention
Official Title: Effect of Online Support and Patient Empowerment on Functional Ability and Well-being in Older Adults: a Pilot Study
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : December 24, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Other Name: Diet, exercise and physical activity advice

Behavioral: Online 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.

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
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Other Name: Diet, exercise and physical activity advice

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
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Other Name: Diet, exercise and physical activity advice

Behavioral: Online 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.

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

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
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Other Name: Diet, exercise and physical activity advice

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




Primary Outcome Measures :
  1. Pilot evaluation - Percentage of participants retained at follow up [ Time Frame: 3 Months ]
    Percentage of participants returned at follow up, reflects the ability to recruit and retain participants.

  2. Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [ Time Frame: 3 months ]
    Scored with the total score ( range of 0-70), and higher scores reflecting better well-being.

  3. Short Physical Performance Battery [ Time Frame: 3 months ]
    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 :
  1. Dietary analysis [ Time Frame: 3 months ]
    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.

  2. Timed-up-and go [ Time Frame: 3 months ]
    The ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again.

  3. Quality of Life SF36 [ Time Frame: 3 months ]
    the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life.

  4. Grip strength [ Time Frame: 3 months ]
    Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength


Other Outcome Measures:
  1. Six minute walking performance [ Time Frame: 3 months ]
    Quantifies the distance able to walk during six minutes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707145


Locations
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United Kingdom
Aberystwyth University
Aberystwyth, Ceredigion, United Kingdom, SY23 3FD
Sponsors and Collaborators
Aberystwyth University
EIT Health
Investigators
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Study Director: John Draper, PhD Aberystwyth University
  Study Documents (Full-Text)

Documents provided by Marco Arkesteijn, Aberystwyth University:
Additional Information:
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Responsible Party: Marco Arkesteijn, Lecturer in Sport and Exercise Biomechanics, Aberystwyth University
ClinicalTrials.gov Identifier: NCT03707145    
Other Study ID Numbers: 9526
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Arkesteijn, Aberystwyth University:
well-being
exercise
physical activity
nutrition
gait
Additional relevant MeSH terms:
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Sarcopenia
Frailty
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical