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Recruiting NCT06819982

Autonomous At Home with Occupational Therapy Support and Assistive Devices

No phase Interventional Frailty Aging Home Care Services

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BCM2.0.
Who it may be relevant to
Registry conditions: Frailty, Aging, Home Care Services. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Autonome À Domicile Grâce À Un Appareil Connecté Et À Un Suivi Ergo

Overview

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.

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.

Interventions

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

Primary outcome measures

  • COPM [Time frame: At enrolment and six months follow up.]
Secondary outcome measures (7)
  • Short FES-I [Time frame: At enrolment and six months follow up.]
  • Health-related QoL [Time frame: At enrolment and six months follow up.]
  • Hospitalisation [Time frame: At enrolment and six months follow up.]
  • Use of assistive devices [Time frame: At enrolment and six months follow up.]
  • Sense of security [Time frame: At enrolment and six months follow up.]
  • Entry in nursing home [Time frame: Any time within the first six months after enrolment.]
  • (I)ADL [Time frame: At enrolment and at six month follow up.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Belgium · 1 center
  • Ergo2.0 — Yvoir

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. PMID 41965516

Identifiers

NCT: NCT06819982 · AUDACE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗