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Completed

NCT Number: NCT03707145

FrAilty Care and wEll-funcTion in Community Dwelling Older Adults

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.

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Key information

Age range

60 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aberystwyth University

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultation

Behavioral

The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual

Other names: Diet, exercise and physical activity advice

Online Support

Behavioral

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

Behavioral

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

Primary outcomes

  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.

    Recruitment took place over a period of 3 months, to recruit 42 participants, with a recruitment rate of 14 participants per month.

  2. Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    Time frame: 3 months

    Scored with the total score ( range of 14-70), 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, which are then added. A total maximum score of 12 reflecting good physical performance and thus higher scores indicate better outcome..

Secondary outcomes

  1. SNAQ -Dietary Analysis

    Time frame: 3 months

    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

  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 outcomes

  1. Six Minute Walking Performance

    Time frame: 3 months

    Quantifies the distance able to walk during six minutes

Sponsors and collaborators

Lead sponsor

Aberystwyth University

Other

Collaborators

  • EIT Health

Registry information

Official study title

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

Acronym: FACET

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Oct 16, 2018
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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