FrAilty Care and wEll-funcTion in Community Dwelling Older Adults

NCT03707145 | Completed Results

• 1 other identifier: 9526
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Sarcopenia; Aging

Keywords

well-being; exercise; physical activity; nutrition; gait

Outcome Measures

Primary Outcomes (3)

• Pilot Evaluation - Percentage of Participants Retained at Follow up

  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.

  3 Months

• Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

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

  3 months

Secondary Outcomes (4)

• SNAQ -Dietary Analysis

  3 months

• Timed-up-and go

  3 months

• Quality of Life SF36

  3 months

• Grip Strength

  3 months

Other Outcomes (1)

• Six Minute Walking Performance

  3 months

Study Arms (4)

Professional led with online support

ACTIVE COMPARATOR

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; Behavioral: Online Support

Professional led without online support

ACTIVE COMPARATOR

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

Patient empowered with online support

EXPERIMENTAL

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; Behavioral: Online Support; Behavioral: Empowered

Patient empowered without online support

ACTIVE COMPARATOR

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; Behavioral: Empowered

Interventions

Consultation BEHAVIORAL

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

Also known as: Diet, exercise and physical activity advice

Patient empowered with online support; Patient empowered without online support; Professional led with online support; Professional led without online support

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.

Patient empowered with online support; Professional led with online support

Empowered BEHAVIORAL

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

Patient empowered with online support; Patient empowered without online support

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aberystwyth University: lead
• EIT Health: collaborator

Study Sites (1)

Aberystwyth University

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39436684 DERIVED

MeSH Terms

Conditions

Frailty; Sarcopenia; Motor Activity

Interventions

Referral and Consultation; Diet; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The incomplete data comprised questionnaires that were completed at home and returned subsequently. Adverse events were not recorded by 13 out of 40 participants, but the documentation did not contain a confirmation box to indicate that 'no adverse events' took place. Thus, although it was assumed that these individuals had no adverse events, it is an assumption, based on non-reporting of adverse events and conversations, but not verified in writing.

Results Point of Contact

• Title: Dr Marco Arkesteijn
• Organization: Aberystwyth University

maa36@aber.ac.uk

+44(0)1970628559

Study Officials

• John Draper, PhD

  Aberystwyth University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Sport and Exercise Biomechanics

Model Details: Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: October 16, 2018
• Study Start: March 30, 2018
• Primary Completion: December 24, 2018
• Study Completion: July 30, 2020
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)