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NCT Number: NCT06592404

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

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

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Key information

Conditions

Brain Injury, Chronic Abnormalities, Multiple Autism Spectrum Disorder Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Child Development Disorders, Pervasive Chromosome Disorders Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Disease Attributes Down Syndrome Genetic Diseases, Inborn Intellectual Disability Intellectual Disability, Mild to Moderate Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SGL, Sittard, Limburg, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Tinybot Tessa

Primary outcomes

  1. Frequency of professional caregiver support per week

    Time frame: During the whole study period (13 weeks) and follow-up 6 months after start of the intervention (2 weeks)

    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.

Secondary outcomes

  1. Goal attainment assessed by Goal Attainment Scaling (GAS)

    Time frame: Differs per cluster: week 4-13 (cluster 1), week 5-13 (cluster 2), week 6-13 (cluster 3), and week 7-13 (cluster 4) and follow-up 6 months after start of the intervention (2 weeks)

    For each participant, 3-5 personal goals are formulated and scored weekly using the Goal Attainment Scaling (GAS) method. The goals have to do with the independent initiation or execution of daily or weekly tasks or activities, such as household tasks, intake of food or medicine, or personal hygiene. After the start of the intervention (using the social robot), the improvement on goals is scored weekly by the professional caregiver using the scale that was formulated for each goal.

    Scores range from -1 to +3, where -1 indicates deterioration compared with the starting situation, 0 indicates no change, 1 indicates improvement below the predefined goal, 2 indicates goal attainment, and 3 indicates improvement exceeding the goal.

  2. Psychosocial impact of technology assessed by the 10-item Psychosocial Impact of Assistive Devices Scale (PIADS-10)

    Time frame: week 13, and follow-up 6 months after start of the intervention

    Conducted in the form of a structured interview at two moments (effect measurement and follow-up period). The 10-item version of the PIADS (Psychosocial Impact of Assistive Device Scale) measures the impact of the social robot on the ability to adapt to the activities of daily living, ability to participate, ability to take advantage of opportunities, eagerness to try new things, happiness, independence, productivity, quality of life, self-esteem, and sense of control.

    The items are scored on a scale from -3 (maximum negative impact) to +3 (maximum positive impact), with negative scores indicating deterioration, neutral scores (0) indicating no change, and positive scores indicating improvement.

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

    Time frame: week 13, and follow-up 6 months after start of the intervention

    Based on a questionnaire filled in at two moments (effect measurement and follow-up period) with the professional caregivers. The questionnaire asks about the social robot's effect on work engagement and about the perceived added value of the social robot for each participant from the perspective of the professional caregiver and the added value for the professional caregiver (the pros and cons of using the social robot).

    The survey questionnaire consists of eight perception statements inspired by the Utrecht Engagement Scale (UBES) covering four conceptual domains: 1) time impact, 2) client outcomes, 3) quality of support provided, and 4) attitudes toward technology. Responses are recorded using a five-point Likert scale ranging from strongly disagree to strongly agree, coded numerically from 0 (strongly disagree) to 4 (strongly agree).

  4. Wellbeing assessed by the Personal Wellbeing Index - Intellectual Disability (PWI-ID)

    Time frame: 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 6 months after intervention starts

    The PWI-ID (Personal Welbeing Index - Intellectual Disability) is administered five times during the study period. The PWI-ID is designed for people who have an intellectual disability or other form of cognitive impairment. The scale measures eight items, each one corresponding to a quality of life domain: life satisfaction, standard of living, health, life achievement, personal relationships, personal safety, community-connectedness, and future security. Responses are recorded using a five-point scale using emojis ranging from very unhappy to very happy, coded numerically as -2 (very unhappy), -1 (unhappy), 0 (neutral), +1 (happy), and +2 (very happy).

  5. Quality of life assessed by the ICEpop CAPability measure for Adults (ICECAP-A)

    Time frame: At start of baseline, in week 13, and follow-up 6 months after start of intervention

    The ICEpop CAPability measure for Adults (ICECAP-A) is recommended in performing cost effectiveness studies. The scale contains five items measuring stability, attachment, autonomy, achievement, and enjoyment. Responses are recorded using a four-point scale ranging from totally unable to totally able, coded numerically from 1 (totally unable) to 4 (totally able).The ICECAP-A is administered three times during the study.

  6. Medical consumption assessed by the iMTA Medical Cost Questionnaire (iMCQ)

    Time frame: At start of baseline, in week 13, and follow-up 6 months after start of intervention

    To measure medical consumption, a questionnaire containing relevant items from the Institute for Medical Technology Assessment (iMTA) Medical Cost Questionnaire (iMCQ) will be used. The iMCQ captures healthcare utilization including general practitioner visits, paramedical care (e.g., physiotherapy), hospital admissions, outpatient visits, and informal care provided by family members with a 12-week recall period. This questionnaire is commonly used to study cost-effectiveness and can be adjusted by selecting relevant items.

  7. Productivity cost assessed by the iMTA Productivity Cost Questionnaire (iPCQ)

    Time frame: At start of baseline, in week 13, and follow-up 6 months after start of intervention

    To measure productivity cost, a questionnaire containing relevant items from the Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) will be used. The iPCQ) records normal working hours and days (paid or unpaid), short-term absenteeism, and long-term work absence by applying a 4-week recal period. This questionnaire is commonly used to study cost-effectiveness and can be adjusted by selecting relevant items.

Sponsors and collaborators

Lead sponsor

Academy Het Dorp

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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