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

NCT06592404 | Recruiting

• 2 other identifiers: AHD23.01910310012210009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (1)

• Frequency of professional caregiver support per week

  This concerns support provided by professional caregivers to the participant regarding the selected activities for which the social robot is used. This support is recorded daily by professional caregivers during the entire study period of 13 weeks and during the two-week follow-up measurement.

  During the whole study period (13 weeks) and 2 weeks follow-up

Secondary Outcomes (3)

• Psychosocial impact of technology assessed by PIADS-10

  week 13, follow-up

• Work engagement and added value of the social robot as experienced by professional caregivers

  week 13, follow-up

• Wellbeing assessed by PWI-ID

  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)

Study Arms (4)

Cluster 1

EXPERIMENTAL

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)

Device: Robot Tessa

Cluster 2

EXPERIMENTAL

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)

Device: Robot Tessa

Cluster 3

EXPERIMENTAL

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)

Device: Robot Tessa

Cluster 4

EXPERIMENTAL

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)

Device: Robot Tessa

Interventions

Robot Tessa 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.

Also known as: Tinybot Tessa

Cluster 1; Cluster 2; Cluster 3; Cluster 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Academy Het Dorp: lead
• Tilburg University: collaborator
• Maastricht University: collaborator
• KU Leuven: collaborator
• Ipse de Bruggen, disability care organisation: collaborator
• SGL, disability care organisation: collaborator
• Hartekamp Groep, disability care organisation: collaborator
• Disability Studies in Nederland, foundation for disability studies in the Netherlands: collaborator
• ZoTeG, academic workplace on technology in disability care: collaborator

Study Sites (3)

SGL

Sittard, Limburg, Netherlands

RECRUITING

Hartekamp Groep

Velserbroek, North Holland, Netherlands

RECRUITING

Ipse de Bruggen

Zoetermeer, South Holland, Netherlands

RECRUITING

MeSH Terms

Conditions

Brain Injury, Chronic; Intellectual Disability; Autism Spectrum Disorder; Down Syndrome

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Brigitte JF Boon, Prof. Dr.

  Academy Het Dorp, Arnhem, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstin N Dam, van, MSc.

CONTACT

+31 88 37 79 999; info@academyhetdorp.nl

Marieke FM Gielissen, Dr.

CONTACT

+31 88 37 79 999; info@academyhetdorp.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: September 19, 2024
• Study Start: November 29, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (3)