Feasibility and Usability of Intrinsic Capacity Monitoring With Eforto and Its Predictive Value for Health Outcomes in Older Community-dwelling Persons

NCT05368337 | Unknown

• 1 other identifier: FORTO 2.0
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

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. 1.to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the eforto® system in the home setting.
2. 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. 3.to explore whether intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue) is related to circulating inflammatory biomarkers.

Conditions

Frailty

Keywords

muscle fatigability; self-monitoring; prevention; self-perceived fatigue

Outcome Measures

Primary Outcomes (53)

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 1

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 2

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 3

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 4

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 5

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 6

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 7

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 8

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 9

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 10

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 11

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 12

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 13

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 14

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 15

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 16

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 17

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 18

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 19

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 20

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 21

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 22

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 23

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 24

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 25

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 26

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 27

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 28

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 29

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 30

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 31

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 32

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 33

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 34

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 35

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 36

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 37

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 38

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 39

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 40

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 41

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 42

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 43

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 44

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 45

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 46

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 47

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 48

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 49

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 50

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 51

• Usability of the eforto® system

  A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' =\> clarify the technical problem.

  Week 52

• Feasibility of the eforto® system

  An self-reported questionnaire (12 questions) based on the technology acceptance model (the Unified Theory of Acceptance Use of Technology (UTAUT)). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.

  End of the study (week 52)

Secondary Outcomes (24)

• The correlation between muscle fatigability and frailty status.

  Baseline

• The correlation between self-perceived fatigue and frailty status.

  Baseline

• The correlation between muscle fatigability and frailty status.

  6 months

• The correlation between self-perceived fatigue and frailty status.

  6 months

• The correlation between muscle fatigability and frailty status.

  12 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling older people aged 65 years and over.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• INNOVIRIS: collaborator
• AAL: collaborator

Related Publications (11)

• 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.

  PMID: 32766674 BACKGROUND

• Frimat M, Teissier T, Boulanger E. Is RAGE the receptor for inflammaging? Aging (Albany NY). 2019 Sep 8;11(17):6620-6621. doi: 10.18632/aging.102256. Epub 2019 Sep 8. No abstract available.

  PMID: 31494645 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Bautmans I, Mets T. A fatigue resistance test for elderly persons based on grip strength: reliability and comparison with healthy young subjects. Aging Clin Exp Res. 2005 Jun;17(3):217-22. doi: 10.1007/BF03324600.

  PMID: 16110735 BACKGROUND

• KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

  PMID: 14044222 BACKGROUND

• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

  PMID: 5349366 BACKGROUND

• Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.

  PMID: 27897430 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

  PMID: 18696313 BACKGROUND

• van Hooff ML, Geurts SA, Kompier MA, Taris TW. "How fatigued do you currently feel?" Convergent and discriminant validity of a single-item fatigue measure. J Occup Health. 2007 May;49(3):224-34. doi: 10.1539/joh.49.224.

  PMID: 17575403 BACKGROUND

• Alberts M, Smets EM, Vercoulen JH, Garssen B, Bleijenberg G. ['Abbreviated fatigue questionnaire': a practical tool in the classification of fatigue]. Ned Tijdschr Geneeskd. 1997 Aug 2;141(31):1526-30. Dutch.

  PMID: 9543741 BACKGROUND

Related Links

• FORTO-aal site
• Frailty in ageing research group VUB site

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ivan Bautmans, Prof Dr

CONTACT

+32 (0)2 477 42 07; ivan.bautmans@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: May 10, 2022
• Study Start: May 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05