FrAilty Care and wEll-funcTion in Community Dwelling Older Adults
NCT ID: NCT03707145
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2018-03-30
2020-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Consultation
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
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.
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.
Consultation
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
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.
Consultation
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
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.
Empowered
The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.
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.
Consultation
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Empowered
The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.
Interventions
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Consultation
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
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.
Empowered
The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
110 Years
ALL
Yes
Sponsors
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EIT Health
OTHER
Aberystwyth University
OTHER
Responsible Party
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Marco Arkesteijn
Lecturer in Sport and Exercise Biomechanics
Principal Investigators
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John Draper, PhD
Role: STUDY_DIRECTOR
Aberystwyth University
Locations
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Aberystwyth University
Aberystwyth, Ceredigion, United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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9526
Identifier Type: -
Identifier Source: org_study_id
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