Autonomous At Home with Occupational Therapy Support and Assistive Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversité Catholique de Louvain
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
People benefiting from other AViQ autonomy programmes of this project are excluded
Trial design
Design model
Single group
Treatments tested in this trial
BCM2.0
Other interventionThe BCM2.0 programme provides occupational therapy sessions and assistive devices to support older people who want to age in place.
Treatment groups
3,900 Participants
are divided into 1 treatment groupGroup A: BCM2.0Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
At enrolment and six months follow up.Secondary outcomes
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
Time frame
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
Time frame
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
Time frame
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).
Time frame
At enrolment and six months follow up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov