Clinical trial NCT06592404: The (Cost)Effectiveness of a Social Robot for Persons with Problems in Daily Structure and Planning in Disability Care
Official title: The (Cost)Effectiveness of a Social Robot in Decreasing Professional Caregiver Support and Increasing Independence for Persons in Disability Care Experiencing Problems in Daily Structure and Planning: a Multiple Baseline Case Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injury, Chronic
Intellectual Disability, Mild to Moderate
Autism Spectrum Disorder
Down Syndrome
Keywords: health care technology
disability care
goal attainment
daily structure and planning
social robot
independence
Lead sponsor: Academy Het Dorp
Sponsor class: OTHER
Collaborators: name: Tilburg University
name: Maastricht University
name: KU Leuven
name: Ipse de Bruggen, disability care organisation
name: SGL, disability care organisation
name: Hartekamp Groep, disability care organisation
name: Disability Studies in Nederland, foundation for disability studies in the Netherlands
name: ZoTeG, academic workplace on technology in disability care
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a multiple baseline single case (MBSC) study, involving individuals receiving long-term disability care and experiencing difficulties in daily structure and planning. Each participant serves as its own control and receives the person-oriented intervention involving a social robot. Participants are randomly assigned to one of four clusters. This randomization determines the duration of three phases during the 13-week study period:

* Control period (care as usual): 2, 3, 4 or 5 weeks, depending on cluster.
* Intervention period (start using the robot): 6 weeks.
* Effect measurement period: 5, 4, 3 or 2 weeks, depending on cluster.

The study period lasts 13 weeks, with a 2-week follow-up measurement scheduled 6 months after the intervention period. The goal is to integrate the social robot into the participants' care plan, with the intention that they continue using the social robot after the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this multiple baseline single case study is to study the (cost)effectiveness of a social robot in reducing professional caregiver support and promoting independence for individuals in long-term disability care experiencing problems with daily structure and planning. The main research questions it aims to answer are:

* What is the effect of the social robot on the frequency of moments professional caregivers support individuals experiencing problems with daily structure and planning with the execution of daily activities, compared to care as usual, after 6 weeks?
* Does the effect of the social robot persist in the long term (after 6 months)?
* What is the cost-effectiveness of the social robot?

Participants will:

* Use a social robot in their daily living environment
* Answer survey questions about their quality of life and wellbeing during the study period
* Share their experiences in interviews

Their profesional caregivers will:

* Register the frequency and duration of support they provide to the participant daily for 13 weeks and a 2-week follow-up
* Give weekly updates and score participants' goal attainment while using the social robot
* Fill in questionnaires on participants' productivity and health care consumption during the study period
* Share their experiences in interviews

Detailed description: Many individuals receiving long-term disability care experience problems in daily structure and planning. This includes people with autism spectrum disorder, mild to moderate intellectual disability, acquired brain injury and/or Down syndrome.

A large number of these individuals need assistance in carrying out daily activities due to these difficulties in planning and organisation. these difficulties include for example being on time for appointments, getting up and going to bed on time, self-care (forgetting to eat or take medication), performing household tasks, and remembering information. Both professional caregivers and clients invest a significant amount of effort, time, and enery into structuring and creating an overview in daily planning.

The use of a social robot that can be programmed to assist with reminders and guidance offers opportunities for both clients and professional caregivers:

* The use of the social robot is expected to lead to more independence and improved well-being for the participant.
* Because the social robot potentially shortens or takes over support moments, professional caregivers might, for example, be deployed more efficiently.
* Positive effects may also be observed in the relationship between professional caregiver and client: when the client functions more independently and their well-being improves, professional caregivers expectedly experience more job satisfaction, which is important for the quality of care and retention of care staff.

The purpose of this study is to research the effectiveness of a social robot in long-term disability care. The study follows participants and their professional caregivers in their daily care setting, first without the social robot (care as usual), then while using the social robot. This study contributes to knowledge about the effective deployment of technology in long-term disability care.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years
* Living in an inpatient long-term disability care facility
* Participant 1) has difficulty with planning and structuring and/or remembering tasks, appointments, and activities, and/or 2) needs outside activation to execute tasks, appointments, and activities
* Able to understand verbal instructions and willing to follow these
* Cognitive capacity to, together with their professional caregiver, set goals to work on with the social robot
* Motivated to work with the social robot on 3-5 goals, for which the participant receives daily or weekly guidance in their home
* Professional caregivers are motivated to participate in the study

Exclusion Criteria:

* Prone to express tension in physical aggression
* Highly sensitive to auditory stimuli

Primary outcomes:
measure: Frequency of professional caregiver support per week
timeFrame: During the whole study period (13 weeks) and 2 weeks follow-up
Secondary outcomes:
measure: Psychosocial impact of technology assessed by PIADS-10
timeFrame: week 13, follow-up
measure: Work engagement and added value of the social robot as experienced by professional caregivers
timeFrame: week 13, follow-up
measure: Wellbeing assessed by PWI-ID
timeFrame: Differs per cluster: week 2, week 8, week 9, week 13 (cluster 1); week 3, week 9, week 10, week 13 (cluster 2); week 4, week 10, week 11, week 13 (cluster 3), week 5, week 11, week 12, week 13 (cluster 4), and follow-up (all clusters)
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: SGL
state: Limburg
city: Velserbroek
country: Netherlands
facility: Hartekamp Groep
state: Noord-Holland
city: Zoetermeer
country: Netherlands
facility: Ipse de Bruggen
state: Zuid-Holland
Study officials:
affiliation: Academy Het Dorp, Arnhem, The Netherlands
name: Brigitte JF Boon, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: