The (Cost)Effectiveness of a Social Robot for Persons with Problems in Daily Structure and Planning in Disability Care

NCT ID: NCT06592404

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Brain Injury, Chronic Intellectual Disability, Mild to Moderate Autism Spectrum Disorder Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cluster 1

As explained earlier on, all clusters receive the person-oriented intervention, which involves deploying the social robot on personal goals related to selected activities.

In this study, randomization determines the duration of study periods.

For cluster 1, periods are planned as follows:

* Control: 2 weeks (week 1-2)
* Intervention: 6 weeks (week 3-8)
* Effect measurement: 5 weeks (week 9-13)
* Follow-up: 2 weeks (week 34-35)

Group Type EXPERIMENTAL

Robot Tessa

Intervention Type DEVICE

Tessa is a small flowerpot shaped robot with two amber LED-lit eyes. The robot is always connected to the power network and internet and speaks reminders at a preset time. These notifications are installed by the user, who can be the professional caregiver or in some cases the participant themselves, using an accessible web app.

Together with the participant and their professional caregiver, selected activities are translated into goals that the robot will support using Goal Attainment Scaling (Kiresuk \& Sherman, 1968), an individualized evaluation method to monitor the progress of (treatment) goals. The goals are evaluated weekly during the study period using a 5-point scale.

Cluster 2

For cluster 2, periods are planned as follows:

* Control: 3 weeks (week 1-3)
* Intervention: 6 weeks (week 4-9)
* Effect measurement: 4 weeks (week 10-13)
* Follow-up: 2 weeks (week 35-36)

Group Type EXPERIMENTAL

Robot Tessa

Intervention Type DEVICE

Tessa is a small flowerpot shaped robot with two amber LED-lit eyes. The robot is always connected to the power network and internet and speaks reminders at a preset time. These notifications are installed by the user, who can be the professional caregiver or in some cases the participant themselves, using an accessible web app.

Together with the participant and their professional caregiver, selected activities are translated into goals that the robot will support using Goal Attainment Scaling (Kiresuk \& Sherman, 1968), an individualized evaluation method to monitor the progress of (treatment) goals. The goals are evaluated weekly during the study period using a 5-point scale.

Cluster 3

For cluster 3, periods are planned as follows:

* Control: 4 weeks (week 1-4)
* Intervention: 6 weeks (week 5-10)
* Effect measurement: 3 weeks (week 11-13)
* Follow-up: 2 weeks (week 36-37)

Group Type EXPERIMENTAL

Robot Tessa

Intervention Type DEVICE

Tessa is a small flowerpot shaped robot with two amber LED-lit eyes. The robot is always connected to the power network and internet and speaks reminders at a preset time. These notifications are installed by the user, who can be the professional caregiver or in some cases the participant themselves, using an accessible web app.

Together with the participant and their professional caregiver, selected activities are translated into goals that the robot will support using Goal Attainment Scaling (Kiresuk \& Sherman, 1968), an individualized evaluation method to monitor the progress of (treatment) goals. The goals are evaluated weekly during the study period using a 5-point scale.

Cluster 4

For cluster 4, periods are planned as follows:

* Control: 5 weeks (week 1-5)
* Intervention: 6 weeks (week 6-11)
* Effect measurement: 2 weeks (week 12-13)
* Follow-up: 2 weeks (week 37-38)

Group Type EXPERIMENTAL

Robot Tessa

Intervention Type DEVICE

Tessa is a small flowerpot shaped robot with two amber LED-lit eyes. The robot is always connected to the power network and internet and speaks reminders at a preset time. These notifications are installed by the user, who can be the professional caregiver or in some cases the participant themselves, using an accessible web app.

Together with the participant and their professional caregiver, selected activities are translated into goals that the robot will support using Goal Attainment Scaling (Kiresuk \& Sherman, 1968), an individualized evaluation method to monitor the progress of (treatment) goals. The goals are evaluated weekly during the study period using a 5-point scale.

Interventions

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Robot Tessa

Tessa is a small flowerpot shaped robot with two amber LED-lit eyes. The robot is always connected to the power network and internet and speaks reminders at a preset time. These notifications are installed by the user, who can be the professional caregiver or in some cases the participant themselves, using an accessible web app.

Together with the participant and their professional caregiver, selected activities are translated into goals that the robot will support using Goal Attainment Scaling (Kiresuk \& Sherman, 1968), an individualized evaluation method to monitor the progress of (treatment) goals. The goals are evaluated weekly during the study period using a 5-point scale.

Intervention Type DEVICE

Other Intervention Names

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Tinybot Tessa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tilburg University

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

Ipse de Bruggen, disability care organisation

UNKNOWN

Sponsor Role collaborator

SGL, disability care organisation

UNKNOWN

Sponsor Role collaborator

Hartekamp Groep, disability care organisation

UNKNOWN

Sponsor Role collaborator

Disability Studies in Nederland, foundation for disability studies in the Netherlands

UNKNOWN

Sponsor Role collaborator

ZoTeG, academic workplace on technology in disability care

UNKNOWN

Sponsor Role collaborator

Academy Het Dorp

OTHER

Sponsor Role lead

Responsible Party

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Brigitte Boon

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brigitte JF Boon, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Academy Het Dorp, Arnhem, The Netherlands

Locations

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SGL

Sittard, Limburg, Netherlands

Site Status RECRUITING

Hartekamp Groep

Velserbroek, North Holland, Netherlands

Site Status RECRUITING

Ipse de Bruggen

Zoetermeer, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Kirstin N Dam, van, MSc.

Role: CONTACT

+31 88 37 79 999

Marieke FM Gielissen, Dr.

Role: CONTACT

+31 88 37 79 999

Facility Contacts

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Gielissen, Dr.

Role: primary

Gielissen, Dr.

Role: primary

Gielissen, Dr.

Role: primary

Other Identifiers

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10310012210009

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AHD23.019

Identifier Type: -

Identifier Source: org_study_id

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