Frailty at Older AdultsNCT03857789
Social Robot Support for Healthcare Professionals
A study testing Questionnaire in people with Frailty at Older Adults, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the effectiveness of integrated care pathway steps supported by social robots. Half of the participants will receive regular care, while for the other half a social robot dialogue will be included as part of the pathway step. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty at Older Adults
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Apr 2019to 28 Feb 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Suspicion of need for quality of life support
Who cannot join
- Psychiatric Disorders
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GC
About this study
Official title: Supporting Health Care Professionals With a Social Robot in an Integrated Care Pathway: A Randomized Controlled Trial
This study evaluates the effectiveness of integrated care pathway steps supported by social robots. Half of the participants will receive regular care, while for the other half a social robot dialogue will be included as part of the pathway step.
Read the detailed description
There is a worldwide increasing shortage of adequately trained healthcare personnel, leading to the challenge for society to prevent a future "lack of care". At the same time the number of people requiring healthcare is expanding rapidly, amongst others due to the growing percentage of older adults in the population. New means of supporting the available healthcare professionals are therefore urgently required.
Modern healthcare is often implemented through "integrated care pathways". Certain steps in these pathways involve dialogues with patients. Speaking social robots are increasingly being advertised as supportive for healthcare professionals and may handle certain structured dialogue types, such as questionnaires. Based on previous positive preclinical experiences with social robots interviewing community-dwelling older subjects, the researchers want to investigate the implementation of a social robot in an integrated care pathway in the outpatient clinic.
- Conditions
- Frailty at Older Adults
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A 40 question frailty questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Regular care | Other | Participant will be received by Healthcare professional (HCP). The HCP will administer a questionnaire. The HCP will discuss the results. Receives: Other: Questionnaire |
| New care | Experimental | Participant will be received by Healthcare professional (HCP). The social robot will administer a questionnaire. The HCP will discuss the results. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumer Quality index (CQ-index)
The CQ-index records the quality of care from a patient perspective using answers to questions like "Would you recommend this outpatient clinic to your family?", "How did you experience the communication with your caregiver?" and "Were you adequately informed?".
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start30 Apr 2019
- Primary completion24 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty at Older AdultsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Delft University of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857789
- Sponsor's protocol ID
- 2018-5019
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boumans R, van Meulen F, van Aalst W, Albers J, Janssen M, Peters-Kop M, Huisman-de Waal G, van de Poll A, Hindriks K, Neerincx M, Olde Rikkert M. Quality of Care Perceived by Older Patients and Caregivers in Integrated Care Pathways With Interviewing Assistance From a Social Robot: Noninferiority Randomized Controlled Trial. J Med Internet Res. 2020 Sep 9;22(9):e18787. doi: 10.2196/18787.
PubMed 32902387
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Health Care Professionals With a Social Robot in an Integrated Care Pathway: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03857789
- Acronym / sponsor ID
- 2018-5019
- Conditions
- Frailty at Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Delft University of Technology
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 28 Feb 2019 (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.
This study evaluates the effectiveness of integrated care pathway steps supported by social robots. Half of the participants will receive regular care, while for the other half a social robot dialogue will be included as part of the pathway step.
Detailed description
There is a worldwide increasing shortage of adequately trained healthcare personnel, leading to the challenge for society to prevent a future "lack of care". At the same time the number of people requiring healthcare is expanding rapidly, amongst others due to the growing percentage of older adults in the population. New means of supporting the available healthcare professionals are therefore urgently required.
Modern healthcare is often implemented through "integrated care pathways". Certain steps in these pathways involve dialogues with patients. Speaking social robots are increasingly being advertised as supportive for healthcare professionals and may handle certain structured dialogue types, such as questionnaires. Based on previous positive preclinical experiences with social robots interviewing community-dwelling older subjects, the researchers want to investigate the implementation of a social robot in an integrated care pathway in the outpatient clinic.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular care | Other | Other: QuestionnaireParticipant will be received by Healthcare professional (HCP). The HCP will administer a questionnaire. The HCP will discuss the results. |
| New care | Experimental | Other: QuestionnaireParticipant will be received by Healthcare professional (HCP). The social robot will administer a questionnaire. The HCP will discuss the results. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Suspicion of need for quality of life support
Key exclusion criteria (1 listed)
- Psychiatric Disorders
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 |
|---|---|---|
| QuestionnaireA 40 question frailty questionnaire. | Other | New care, Regular care |
Primary outcome
Consumer Quality index (CQ-index)
Time frame: 4 Months
The CQ-index records the quality of care from a patient perspective using answers to questions like "Would you recommend this outpatient clinic to your family?", "How did you experience the communication with your caregiver?" and "Were you adequately informed?".
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 9 Mar 2020.
- Derived from this study: PubMed 32902387Boumans R, van Meulen F, van Aalst W, Albers J, Janssen M, Peters-Kop M, Huisman-de Waal G, van de Poll A, Hindriks K, Neerincx M, Olde Rikkert M. Quality of Care Perceived by Older Patients and Caregivers in Integrated Care Pathways With Interviewing Assistance From a Social Robot: Noninferiority Randomized Controlled Trial. J Med Internet Res. 2020 Sep 9;22(9):e18787. doi: 10.2196/18787.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Frailty at Older Adults, run by Radboud University Medical Center at 1 site 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 1 inclusion and 1 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Consumer Quality index (CQ-index) (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857789, which also lists 1 linked publication.
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 9 Mar 2020.