Autonomous At Home with Occupational Therapy Support and Assistive Devices

NCT06819982 | Recruiting

• 1 other identifier: AUDACE
• Study Type: interventional
• Target: 3,900
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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

  At enrolment and six months follow up.

Secondary Outcomes (7)

• Short FES-I

  At enrolment and six months follow up.

• Health-related QoL

  At enrolment and six months follow up.

• Hospitalisation

  At enrolment and six months follow up.

• Use of assistive devices

  At enrolment and six months follow up.

• Sense of security

  At enrolment and six months follow up.

Study Arms (1)

BCM2.0

EXPERIMENTAL

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

Other: BCM2.0

Interventions

BCM2.0 OTHER

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

BCM2.0

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Ergo2.0

Yvoir, B-5530, Belgium

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thérèse Van Durme

CONTACT

+32 (0)2 764 30 99; therese.vandurme@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 11, 2025
• Study Start: March 4, 2024
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be shared after the complete study data has been collected and anonymised (expected data: january 2026). This data will remain available on dataverse.uclouvain.be with no end date. ICF and study protocol will be published in a scientific journal. This data will remain available on the journal website with no end date.

Locations

BE (1)