FrAilty Care and wEll-funcTion in Community Dwelling Older Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Frailty, Sarcopenia, Aging

Intervention / Treatment
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* Behavioral: Consultation
* Behavioral: Online Support
* Behavioral: Empowered


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Professional led with online support<br>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<br>* The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual<br>* Other names: Diet, exercise and physical activity advice;Behavioral: Online Support<br>* 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.<br>|
| Active Comparator: Professional led without online support<br>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<br>* The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual<br>* Other names: Diet, exercise and physical activity advice;|
| Experimental: Patient empowered with online support<br>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<br>* The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual<br>* Other names: Diet, exercise and physical activity advice;Behavioral: Online Support<br>* 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.<br>Behavioral: Empowered<br>* The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.<br>|
| Active Comparator: Patient empowered without online support<br>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<br>* The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual<br>* Other names: Diet, exercise and physical activity advice;Behavioral: Empowered<br>* The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot evaluation - Percentage of participants retained at follow up | Percentage of participants returned at follow up, reflects the ability to recruit and retain participants. | 3 Months | 
| Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | Scored with the total score ( range of 0-70), and higher scores reflecting better well-being. | 3 months | 
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| 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. | 3 months | 
| 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. | 3 months | 
| Grip strength | Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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well-being, exercise, physical activity, nutrition, gait