NCT06270979

Brief Summary

In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal 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 ISHA system in rehabilitation and nursing home settings.
  2. 2.to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.
  3. 3.to explore individual trajectories of intrinsic capacity with the ISHA system.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

January 12, 2024

Last Update Submit

February 13, 2024

Conditions

Frailty

Keywords

Self-monitoringIntrinsic capacityPrevention

Outcome Measures

Primary Outcomes (17)

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Potential technical problems of the ISHA system

    A checklist of potential technical problems (12 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

  • Experiences with ISHA (usability, feasibility and acceptability outcome)

    An self-reported questionnaire (19 questions) based on the System Usability Scale (SUS). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.

    End of the study (week 16)

Secondary Outcomes (48)

  • The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB

    Baseline

  • The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB

    2 months

  • The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB

    4 months

  • The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB

    Baseline

  • The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB

    2 months

  • +43 more secondary outcomes

Study Arms (2)

Leiehome vzw

Participant recruitment entails including persons aged 65 years or older living in an assisted housing or a nursing home.

Device: ISHA

University Hospital Antwerp/University of Antwerp

Participant recruitment entails including persons aged 65 years or older undergoing rehabilitation at University Hospital Antwerp.

Device: ISHA

Interventions

ISHADEVICE

Participants will be provided with an Eforto® device and ISHA mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver).

Leiehome vzwUniversity Hospital Antwerp/University of Antwerp

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing rehabilitation and nursing home residents, all aged 65 years or older.

You may qualify if:

  • Aged 65 years or older.
  • Patients living independently at home and undergoing rehabilitation, or older persons living in the residential care community (in a nursing home or in assisted 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.

You may not qualify if:

  • Being unable to perform the physical (self)tests (e.g., unable to stand up or walk);
  • Being unable to understand the test instructions;
  • Functional disability of the dominant upper extremity (paresis/paralysis, tremor or recent surgery);
  • Patients undergoing neurological rehabilitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ivan Bautmans, Prof. Dr.

    VUB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Bautmans, Prof. Dr.

CONTACT

+32 (0)2 477 42 07Ivan.Bautmans@vub.be

Study Design

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

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 21, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

February 21, 2024

Record last verified: 2024-02