Clinical trial NCT06819982: Autonomous At Home with Occupational Therapy Support and Assistive Devices
Official title: Autonome À Domicile Grâce À Un Appareil Connecté Et À Un Suivi Ergo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Aging
Home Care Services
Keywords: Education, Continuing
Home Care Services
Monitoring, Ambulatory
Occupational Therapy
Personal Autonomy
Primary Health Care / methods
Program Evaluation
Self-Help Devices
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 3900
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

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

Primary outcomes:
measure: COPM
timeFrame: At enrolment and six months follow up.
Secondary outcomes:
measure: Short FES-I
timeFrame: At enrolment and six months follow up.
measure: Health-related QoL
timeFrame: At enrolment and six months follow up.
measure: Hospitalisation
timeFrame: At enrolment and six months follow up.
measure: Use of assistive devices
timeFrame: At enrolment and six months follow up.
measure: Sense of security
timeFrame: At enrolment and six months follow up.
measure: Entry in nursing home
timeFrame: Any time within the first six months after enrolment.
measure: (I)ADL
timeFrame: At enrolment and at six month follow up.
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: Ergo2.0
Study officials:
References: