AzTrials
AzTrials

FrailtyAUDACENCT06819982

Autonomous At Home with Occupational Therapy Support and Assistive Devices

A study testing BCM2.0 in people with Frailty and Aging, run by Université Catholique de Louvain at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of the AUDACE study is to evaluate the 'Bien chez Moi 2.0' programme, to assess how, for whom and why do assistive devices, integrated with occupational therapy support, enable older people to remain at home, and under what conditions? The study assesses the impact on areas such as the degree of autonomy, the… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty, Aging, Home Care Services
What is being tested?
BCM2.0
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,900 participants
Where
1 siteBelgium
Study dates
4 Mar 2024to 4 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • people aged 65 and over
  • living at home in the Walloon and Brussels regions
  • who are considered frail or at risk of frailty. The risk of frailty is defined as having at least one loss of intrinsic capacity measured by a trained occupational therapist using the ICOPE screening tool

Who cannot join

  • People benefiting from other AViQ autonomy programmes of this project are excluded

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thérèse Van Durme contact

+32 (0)2 764 30 99

therese.vandurme@uclouvain.be

Belgium1 site, 1 recruiting

  • Ergo2.0

    Yvoir, B-5530

    François Galand, +32 (0)4 79 22 65 83, ergo2.0.coordination@gmail.com

    Recruiting

Other trials in Belgium

About this study

Official title: Autonome À Domicile Grâce À Un Appareil Connecté Et À Un Suivi Ergo

The aim of the AUDACE study is to evaluate the 'Bien chez Moi 2.0' programme, to assess how, for whom and why do assistive devices, integrated with occupational therapy support, enable older people to remain at home, and under what conditions? The study assesses the impact on areas such as the degree of autonomy, the extent to which life goals are taken into account, the feeling of security at home, the use of hospital emergency services and the postponement of definitive institutionalisation in a nursing home. The expected results of this study are to be able to robustly describe the impact of the 'Bien chez moi 2.0' programme in the areas listed above.

Read the detailed description

Background The BCM2.0 programme provides occupational therapy sessions and assistive devices to support older people who want to age in place. The investigators designed the AUDACE evaluation to improve understanding of the programme and its effectiveness, and to promote a favourable context for the professional empowerment of occupational therapists as primary care providers.

Methods The investigators involved home care occupational therapists at every stage of the protocol design to ensure that the tools, training, and organisational structures put in place for the evaluation could also form the basis of their routine practice, harmonising their practices, ethos and processes.

The investigators designed a realist mixed methods evaluation to answer the following question: "How, for whom and why do assistive devices, integrated with occupational therapy support, enable older people to remain at home, and under what conditions?" Interrelated components addressed different research sub-questions: (1a) To describe the evaluation population, interventions, and contexts: a descriptive quantitative study using baseline data from all BCM2.0 beneficiaries. (1b) To describe the frailty process in older people receiving the programme: a qualitative study using semi-structured individual interviews with a biographical dimension. (2) To explore the enrolment process: focus groups with occupational therapists, following a realist approach. (3) To assess effectiveness: a prospective cohort study with up to 12 months follow-up of all BCM2.0 beneficiaries. (4) To identify barriers and facilitators to implementation: multiple nested case study in five areas, using a realist approach. (5) To build a learning community to clarify ethical considerations: communities of practice meetings.

Being tested
BCM2.0
Keywords
Education, Continuing, Home Care Services, Monitoring, Ambulatory, Occupational Therapy, Personal Autonomy, Primary Health Care / methods, Program Evaluation, Self-Help Devices
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCM2.0Other

    The BCM2.0 programme provides occupational therapy sessions and assistive devices to support older people who want to age in place.

Study groups in NCT06819982
Study groupRoleWhat they receive
BCM2.0ExperimentalThe BCM2.0 programme provides occupational therapy sessions and assistive devices to support older people who want to age in place.
Receives: Other: BCM2.0

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COPM

    Endpoints will be calculated as the within-subject difference in measurement between baseline and six-month follow-up in Canadian Occupational Performance Measure (COPM), assessing daily occupations of importance that people are unable to perform.

    Scale description:

    Canadian Occupational Performance Measure Range 1-10 Higher score = Better outcome

    Measured: At enrolment and six months follow up.

Secondary outcomes (7)

  1. Short FES-I

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for short FES-I (short Fall efficacy scale - international, measuring concern over the possibility of falling)

    Scale description:

    short Fall efficacy scale - international Range 7-28 Higher score = Worse outcome

    Measured: At enrolment and six months follow up.

  2. Health-related QoL

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for EQ-5D-5L mapped to Belgian utility scores.

    Scale description:

    EQ-5D-5L Range: Below 0 to 1 Higher score = Better outcome

    Measured: At enrolment and six months follow up.

  3. Hospitalisation

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for use of hospitalisation and institutionalisation in a nursing home (number of stay in the last six months).

    Scale description:

    Number of stay in hospital or nursing home Range: 0+ Higher score = Worse outcome

    Measured: At enrolment and six months follow up.

  4. Use of assistive devices

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for use of assistive devices (binary response).

    Measured: At enrolment and six months follow up.

  5. Sense of security

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for sense of security (on a 7-point Likert scale).

    Range: 1-7 Higher score = Better outcome

    Measured: At enrolment and six months follow up.

  6. Entry in nursing home

    Days since enrolment when the person entered a nursing home.

    Analysed as a right censored variable. The event happening in a worse outcome. Death is treated as censoring.

    Measured: Any time within the first six months after enrolment.

  7. (I)ADL

    Endpoint will be calculated as the within-subject difference in measurement between baseline and six-month follow-up for ad-hoc questions on assistance received on(I)ADL domains.

    (Instrumental) Activities of Daily Living How many of 15 activities need help to be performed? Two scores: informal caregiver help, and professional caregiver help.

    Range: 0-15 Higher value = Worse outcome

    Measured: At enrolment and at six month follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start4 Mar 2024
  3. Primary completion4 Sep 2025 (estimated)
  4. Study completion4 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06819982
Sponsor's protocol ID
AUDACE
Acronym
AUDACE
Status last verified
Jan 2025
First submitted
28 Jan 2025
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared for all collected data. Pseudonymised individual study data will undergo an anonymisation process with the help of an expert in data anonymity to ensure that no combination of data would allow re-identification of participants. The data will be publicly available on UCLouvain's public open data repository http://dataverse.uclouvain.be/.

Publications

  • Filipovic-Pierucci A, Alvarez Irusta L, de la Croix T, Ledoux A, Van Durme T. AUDACE: a study protocol for the realist mixed methods evaluation of the BCM2.0 occupational therapy and assistive device programme for older people aging in place. BMC Prim Care. 2026 Apr 11;27(1):201. doi: 10.1186/s12875-026-03306-5.

    PubMed 41965516

Questions about this trial

What is this clinical trial studying?

A study testing BCM2.0 in people with Frailty and Aging, run by Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thérèse Van Durme (+32 (0)2 764 30 99, therese.vandurme@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COPM (time frame: At enrolment and six months follow up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06819982, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in