Clinical trial NCT05368337: Feasibility and Usability of Intrinsic Capacity Monitoring With Eforto and Its Predictive Value for Health Outcomes in Older Community-dwelling Persons
Official title: Feasibility and Usability of Intrinsic Capacity Monitoring With Eforto and Its Predictive Value for Health Outcomes in Older Community-dwelling Persons
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Keywords: muscle fatigability
self-monitoring
prevention
self-perceived fatigue
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: INNOVIRIS
name: AAL
First posted: 2022-05-10
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling older people aged 65 years and over.

Brief summary: In this study, 160 community-dwelling older adults (65 years and older) will be provided with an eforto® system to self-monitor their muscle fatigability and self-perceived fatigue for 2 consecutive days per week during 12 months (if needed with assistance by an informal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.

The aims of the study are:

1. to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the eforto® system in the home setting.
2. to investigate if changes and variability in intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue), are related to changes in frailty status, functional independency and quality of life.
3. to explore whether intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue) is related to circulating inflammatory biomarkers.

Detailed description: Investigational device:

The eforto® system was developed based on approximatively 20 years of scientific research on handgrip muscle fatigability performed by the Frailty in Ageing research department (see https://fria.research.vub.be/) and in collaboration with top-level international partners.

The eforto® system allows self-assessment of muscle fatigability and self-perceived fatigue in older adults and functions as a monitoring tool for intrinsic capacity. It is a small device, easy to use, and suitable for home measurements as well as hospital settings. When used correctly, the measurements cause no discomfort and can be performed repeatedly. The rubber bulb connects to a smartphone application that provides verbal test instructions to the participant. The app will guide the participant during the test and automatically provide motivational cues via audio. The test results are aggregated and stored in a cloud platform where the researcher can manage subjects, access the test data and export it for further analysis. The mobile app supports Dutch, French and English.

In a previous study, eforto® was clinically validated against a gold-standard pressure gauge in n=61 community-dwelling older adults, n=26 hospitalized geriatric patients and n=25 older hip fracture patients. Moreover, the usability and acceptance of eforto® self-monitoring (1 week) was demonstrated in a sample of n=30 community dwelling older persons aged between 83 and 95 years old. (paper submitted for publication in international peer-reviewed journal)

Procedures:

After the recruitment, a researcher will estimate whether the participant is eligible for the study during a eligibility check by a telephone call and legally capable to provide consent. After informed consent is given, baseline measurements will take place. These measurements will be reassessed after 6 months and 12 months. After an individual information session explaining how to use eforto®, the participant will be instructed to perform the eforto® measurements for 2 consecutive days per week for 12 months at home (if needed with assistance by an informal caregiver). Preferentially, the researcher will install the eforto® application on the smartphone of the participant. The home measurements will be continued for 12 months or until withdrawal of the participant. During the study, there will be a monthly telephone contact between participants and researchers in order to register technical problems, and self-reported changes in health situation.

Eligibility criteria: Inclusion Criteria:

* Aged 65 years and over
* Living in the community (independently at home or at home assisted by an informal caregiver or in assistive housing)
* Being able to operate the basic functions of a smartphone (if needed with assistance by an informal caregiver): using a smartphone at least for calls and minimum 1 other application
* Understanding Dutch or French
* Simple Frail Scale score \<3

Exclusion Criteria:

Being unable to participate in the assessments due to:

* Physical impairments (e.g. unable to stand up or walk)
* Cognitive impairments (unable to understand the test instructions and/or Mini Mental State Examination (MMSE) score \<23/30)
* Functional disability of the dominant upper extremity (pare-sis/paralysis, tremor or recent surgery)

Primary outcomes:
measure: Usability of the eforto® system
timeFrame: Week 1
measure: Usability of the eforto® system
timeFrame: Week 2
measure: Usability of the eforto® system
timeFrame: Week 3
measure: Usability of the eforto® system
timeFrame: Week 4
measure: Usability of the eforto® system
timeFrame: Week 5
measure: Usability of the eforto® system
timeFrame: Week 6
measure: Usability of the eforto® system
timeFrame: Week 7
measure: Usability of the eforto® system
timeFrame: Week 8
measure: Usability of the eforto® system
timeFrame: Week 9
measure: Usability of the eforto® system
timeFrame: Week 10
measure: Usability of the eforto® system
timeFrame: Week 11
measure: Usability of the eforto® system
timeFrame: Week 12
measure: Usability of the eforto® system
timeFrame: Week 13
measure: Usability of the eforto® system
timeFrame: Week 14
measure: Usability of the eforto® system
timeFrame: Week 15
measure: Usability of the eforto® system
timeFrame: Week 16
measure: Usability of the eforto® system
timeFrame: Week 17
measure: Usability of the eforto® system
timeFrame: Week 18
measure: Usability of the eforto® system
timeFrame: Week 19
measure: Usability of the eforto® system
timeFrame: Week 20
measure: Usability of the eforto® system
timeFrame: Week 21
measure: Usability of the eforto® system
timeFrame: Week 22
measure: Usability of the eforto® system
timeFrame: Week 23
measure: Usability of the eforto® system
timeFrame: Week 24
measure: Usability of the eforto® system
timeFrame: Week 25
measure: Usability of the eforto® system
timeFrame: Week 26
measure: Usability of the eforto® system
timeFrame: Week 27
measure: Usability of the eforto® system
timeFrame: Week 28
measure: Usability of the eforto® system
timeFrame: Week 29
measure: Usability of the eforto® system
timeFrame: Week 30
measure: Usability of the eforto® system
timeFrame: Week 31
measure: Usability of the eforto® system
timeFrame: Week 32
measure: Usability of the eforto® system
timeFrame: Week 33
measure: Usability of the eforto® system
timeFrame: Week 34
measure: Usability of the eforto® system
timeFrame: Week 35
measure: Usability of the eforto® system
timeFrame: Week 36
measure: Usability of the eforto® system
timeFrame: Week 37
measure: Usability of the eforto® system
timeFrame: Week 38
measure: Usability of the eforto® system
timeFrame: Week 39
measure: Usability of the eforto® system
timeFrame: Week 40
measure: Usability of the eforto® system
timeFrame: Week 41
measure: Usability of the eforto® system
timeFrame: Week 42
measure: Usability of the eforto® system
timeFrame: Week 43
measure: Usability of the eforto® system
timeFrame: Week 44
measure: Usability of the eforto® system
timeFrame: Week 45
measure: Usability of the eforto® system
timeFrame: Week 46
measure: Usability of the eforto® system
timeFrame: Week 47
measure: Usability of the eforto® system
timeFrame: Week 48
measure: Usability of the eforto® system
timeFrame: Week 49
measure: Usability of the eforto® system
timeFrame: Week 50
measure: Usability of the eforto® system
timeFrame: Week 51
measure: Usability of the eforto® system
timeFrame: Week 52
measure: Feasibility of the eforto® system
timeFrame: End of the study (week 52)
Secondary outcomes:
measure: The correlation between muscle fatigability and frailty status.
timeFrame: Baseline
measure: The correlation between self-perceived fatigue and frailty status.
timeFrame: Baseline
measure: The correlation between muscle fatigability and frailty status.
timeFrame: 6 months
measure: The correlation between self-perceived fatigue and frailty status.
timeFrame: 6 months
measure: The correlation between muscle fatigability and frailty status.
timeFrame: 12 months
measure: The correlation between self-perceived fatigue and frailty status.
timeFrame: 12 months
measure: The correlation between muscle fatigability and functional independency.
timeFrame: At baseline
measure: The correlation between self-perceived fatigue and functional independency.
timeFrame: At baseline
measure: The correlation between muscle fatigability and functional independency.
timeFrame: 6 months
measure: The correlation between self-perceived fatigue and functional independency.
timeFrame: 6 months
measure: The correlation between muscle fatigability and functional independency.
timeFrame: 12 months
measure: The correlation between self-perceived fatigue and functional independency.
timeFrame: 12 months
measure: The correlation between muscle fatigability and quality of life.
timeFrame: At baseline
measure: The correlation between self-perceived fatigue and quality of life.
timeFrame: At baseline
measure: The correlation between muscle fatigability and quality of life.
timeFrame: 6 months
measure: The correlation between self-perceived fatigue and quality of life.
timeFrame: 6 months
measure: The correlation between muscle fatigability and quality of life.
timeFrame: 12 months
measure: The correlation between self-perceived fatigue and quality of life.
timeFrame: 12 months
measure: The correlation between muscle fatigability and circulating inflammatory biomarkers.
timeFrame: At baseline
measure: The correlation between muscle fatigability and circulating inflammatory biomarkers.
timeFrame: 6 months
measure: The correlation between muscle fatigability and circulating inflammatory biomarkers.
timeFrame: 12 months
measure: The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
timeFrame: At baseline
measure: The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
timeFrame: 6 months
measure: The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Rasmussen LJH, Caspi A, Ambler A, Danese A, Elliott M, Eugen-Olsen J, Hariri AR, Harrington H, Houts R, Poulton R, Ramrakha S, Sugden K, Williams B, Moffitt TE. Association Between Elevated suPAR, a New Biomarker of Inflammation, and Accelerated Aging. J Gerontol A Biol Sci Med Sci. 2021 Jan 18;76(2):318-327. doi: 10.1093/gerona/glaa178.
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