Clinical trial NCT03707145: FrAilty Care and wEll-funcTion in Community Dwelling Older Adults
Official title: Effect of Online Support and Patient Empowerment on Functional Ability and Well-being in Older Adults: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Sarcopenia
Aging
Keywords: well-being
exercise
physical activity
nutrition
gait
Lead sponsor: Aberystwyth University
Sponsor class: OTHER
Collaborators: name: EIT Health
First posted: 2018-10-16
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pilot Evaluation - Percentage of Participants Retained at Follow up
timeFrame: 3 Months
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: 3 months
measure: Short Physical Performance Battery
timeFrame: 3 months
Secondary outcomes:
measure: SNAQ -Dietary Analysis
timeFrame: 3 months
measure: Timed-up-and go
timeFrame: 3 months
measure: Quality of Life SF36
timeFrame: 3 months
measure: Grip Strength
timeFrame: 3 months
Other outcomes:
measure: Six Minute Walking Performance
timeFrame: 3 months
Locations:
city: Aberystwyth
country: United Kingdom
facility: Aberystwyth University
state: Ceredigion
Study officials:
affiliation: Aberystwyth University
name: John Draper, PhD
role: STUDY_DIRECTOR
References: