Brain Injury, ChronicNCT06592404
The (Cost)Effectiveness of a Social Robot for Persons With Problems in Daily Structure and Planning in Disability Care
A study testing Robot Tessa in people with Brain Injury, Chronic and Intellectual Disability, Mild to Moderate, run by Academy Het Dorp at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Chronic, Intellectual Disability, Mild to Moderate, Autism Spectrum Disorder
- What is being tested?
- Robot Tessa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesNetherlands
- Study dates
- 29 Nov 2023to 21 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prone to express tension in physical aggression
- Highly sensitive to auditory stimuli
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Abrona
Huis ter Heide, Utrecht
SGL
Sittard, Limburg
Hartekamp Groep
Velserbroek, North Holland
Ipse de Bruggen
Zoetermeer, South Holland
About this study
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
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?
Read more
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
Read the 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.
- Conditions
- Brain Injury, Chronic, Intellectual Disability, Mild to Moderate, Autism Spectrum Disorder, Down Syndrome
- Being tested
- Robot Tessa
- Keywords
- health care technology, disability care, goal attainment, daily structure and planning, social robot, independence
- Medical subject headings
- Brain Injury, Chronic, Intellectual Disability, Autism Spectrum Disorder, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot TessaDevice
Also called Tinybot 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Robot Tessa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the whole study period (13 weeks) and follow-up 6 months after start of the intervention (2 weeks)
Secondary outcomes (7)
Goal attainment assessed by Goal Attainment Scaling (GAS)
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.
Measured: 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)
Psychosocial impact of technology assessed by the 10-item Psychosocial Impact of Assistive Devices Scale (PIADS-10)
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.
Measured: week 13, and follow-up 6 months after start of the intervention
Work engagement and added value of the social robot as experienced by professional caregivers
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).
Measured: week 13, and follow-up 6 months after start of the intervention
Wellbeing assessed by the Personal Wellbeing Index - Intellectual Disability (PWI-ID)
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).
Measured: 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
Quality of life assessed by the ICEpop CAPability measure for Adults (ICECAP-A)
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.
Measured: At start of baseline, in week 13, and follow-up 6 months after start of intervention
Medical consumption assessed by the iMTA Medical Cost Questionnaire (iMCQ)
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.
Measured: At start of baseline, in week 13, and follow-up 6 months after start of intervention
Productivity cost assessed by the iMTA Productivity Cost Questionnaire (iPCQ)
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.
Measured: At start of baseline, in week 13, and follow-up 6 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Nov 2023
- Primary completion21 Sep 2025
- Study completion21 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy Het Dorp
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University, Maastricht University, KU Leuven, Ipse de Bruggen, disability care organisation, SGL, disability care organisation, Hartekamp Groep, disability care organisation, Disability Studies in Nederland, foundation for disability studies in the Netherlands, ZoTeG, academic workplace on technology in disability care
- Responsible party
- Principal investigator, Brigitte Boon, Academy Het Dorp
- Investigators
- Brigitte JF Boon, Prof. Dr., Principal investigator, Academy Het Dorp, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592404
- Sponsor's protocol ID
- AHD23.019
- Other IDs
- 10310012210009
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06592404
- Acronym / sponsor ID
- AHD23.019
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Academy Het DorpUniversity, hospital or other
- Collaborators
- Tilburg University, Maastricht University, KU Leuven, Ipse de Bruggen, disability care organisation, SGL, disability care organisation, Hartekamp Groep, disability care organisation, Disability Studies in Nederland, foundation for disability studies in the Netherlands, ZoTeG, academic workplace on technology in disability care
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 21 Sep 2025 (actual)
- Study completion
- 21 Sep 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cluster 1 | Experimental | Device: Robot TessaAs 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) |
| Cluster 2 | Experimental | Device: Robot TessaFor 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) |
| Cluster 3 | Experimental | Device: Robot TessaFor 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) |
| Cluster 4 | Experimental | Device: Robot TessaFor 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Prone to express tension in physical aggression
- Highly sensitive to auditory stimuli
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot TessaAlso: Tinybot TessaTessa 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. | Device | Cluster 1, Cluster 2, Cluster 3, Cluster 4 |
Primary outcome
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.
7 secondary outcomes
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)
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte JF Boon, Prof. Dr. principal investigator
Academy Het Dorp, Arnhem, The Netherlands
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Tessa in people with Brain Injury, Chronic and Intellectual Disability, Mild to Moderate, run by Academy Het Dorp at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.