DementiaNCT05439304
RoboCare - Technology in Care Homes
An observational study of Dementia, run by Helse Stavanger HF.
Trial summary
This study primary objective of this study is to identify promoting and hindering factors that affect the implementation of a smart robot in a care home setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be recruited from two care homes also included in the cluster RCT. For diversity purposes, we seek to include both large and smaller care homes from larger cities and rural areas and purposely include two different units from each care to reflect the variety of experiences.
Who may be able to join
- Dementia diagnosis at the time of inclusion equivalent with stage 5 (Moderately severe cognitive decline) on the Functional Assessment Staging Tool (FAST)
Who cannot join
- Any participants who are not able to give informed consent themselves or through a consultee will not be included in the project.
- Family member
- All family members of included residents will be invited to participate in the project
Trial locations and contacts
No sites are listed yet.
About this study
Official title: RoboCare - Implementation of a Smart Robot in Care Homes
This study primary objective of this study is to identify promoting and hindering factors that affect the implementation of a smart robot in a care home setting.
Read the detailed description
People living with dementia represents a vulnerable group with a high need for person centred care to maintain a high quality of life. Loneliness and social isolation is already a common problem in care homes and has become a global challenge during the pandemic because of its negative effect on health. As a response to missing social interactions, technology with the intent to enhance communication and encourage activities have been introduced in care homes. However, there is a lack of knowledge about the introduction and use of technology. To gain insight into this, Centre for Age-Related Medicine at Stavanger University Hospital SESAM has carried out a pilot project made possible by DAM Foundation, where the smart robot Berntsen (hereinafter referred to as Berntsen) was used for video communication. The pilot project show that the use requires organizational leadership, motivated care staff and a well-organized introduction, and that there is a great need for more knowledge about these factors in order to develop a good implementation strategy.
Hence, SESAM has started the ground breaking project "RoboCare - Effectiveness, efficiency, uptake and use of a smart robot in care homes: A cluster randomized trial and implementation study" to investigate if Berntsen can reduce loneliness and social isolation, increase residents' quality of life and increase staff job satisfaction. Berntsen is an iPad on a stand with wheels or a tripod suitable for tabled tops, with content that can be customized to the user. It can promote person centred activities, tailored schedules and facilitate video communication. Berntsen can also act as a personal trainer with customized exercise videos in collaboration with a physical therapist.
This study will be part of the cluster RCT to explore which factors are important for implementation from the micro-level (person with dementia, family member and staff) perspective, and what must be set for optimal use of Berntsen in a care home.
It is of vital importance that all stakeholders are involved in an implementation process to integrate technology. These aspects are however less described in research concerning development of technological interventions in care homes. Consequently, knowledge concerning care staff, residents and informal carers is scarce.
Design: An explorative qualitative study consisting of 3 sub studies:
- A qualitative study to investigate the resident, family member and care staff perspective on implementation and use of technology in a care home setting
- A qualitative study to investigate the resident, family member and care staff experience using Berntsen as part of daily practice and for communication.
- A qualitative observational study to investigate the dynamic between people living with dementia and family member during communication through Berntsen.
- Conditions
- Dementia
- Being tested
- No intervention
- Keywords
- Care home, Technology, Person centred care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Care staff | Not described Receives: Other: No intervention | |
| Residents | Not described Receives: Other: No intervention | |
| Family members | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hindering and promoting factors to technology implementation
Measured using qualitative interviews with care staff, residents and family members and observation of residents and family members
Measured: Three years
Secondary outcomes (3)
Implementation and use of technology in a care home setting
Measured by qualitative focus group interviews with care staff, and individual interviews with residents and family members in dyads. Interviews will be based on semi-structured interview guide.
Measured: July - December 2022
User perspective on Berntsen
Measured by qualitative focus group interviews with care staff, and individual interviews with residents and family members in dyads. Interviews will be based on semi-structured interview guide.
Measured: January - June 2023
People with dementia and family member communication through Berntsen
Measured by observation of people living with dementia and family members during communication through Berntsen. Observations will be based on an observation guide.
Measured: July - December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- The Dam Foundation, Norwegian Health Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439304
- Sponsor's protocol ID
- 401080
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ballard C, Corbett A, Orrell M, Williams G, Moniz-Cook E, Romeo R, Woods B, Garrod L, Testad I, Woodward-Carlton B, Wenborn J, Knapp M, Fossey J. Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial. PLoS Med. 2018 Feb 6;15(2):e1002500. doi: 10.1371/journal.pmed.1002500. eCollection 2018 Feb.
PubMed 29408901Barbosa Neves B, Sanders A, Kokanovic R. "It's the worst bloody feeling in the world": Experiences of loneliness and social isolation among older people living in care homes. J Aging Stud. 2019 Jun;49:74-84. doi: 10.1016/j.jaging.2019.100785. Epub 2019 Jun 6.
PubMed 31229221Ko M, Wagner L, Spetz J. Nursing Home Implementation of Health Information Technology: Review of the Literature Finds Inadequate Investment in Preparation, Infrastructure, and Training. Inquiry. 2018 Jan-Dec;55:46958018778902. doi: 10.1177/0046958018778902.
PubMed 29888677Khosravi P, Ghapanchi AH. Investigating the effectiveness of technologies applied to assist seniors: A systematic literature review. Int J Med Inform. 2016 Jan;85(1):17-26. doi: 10.1016/j.ijmedinf.2015.05.014. Epub 2015 Jun 11.
PubMed 26216463
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RoboCare - Implementation of a Smart Robot in Care Homes
- ClinicalTrials.gov ID
- NCT05439304
- Acronym / sponsor ID
- 401080
- Conditions
- Dementia
- Keywords
- Care home, Technology, Person centred care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- The Dam Foundation, Norwegian Health Association
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Jun 2022 (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 primary objective of this study is to identify promoting and hindering factors that affect the implementation of a smart robot in a care home setting.
Detailed description
People living with dementia represents a vulnerable group with a high need for person centred care to maintain a high quality of life. Loneliness and social isolation is already a common problem in care homes and has become a global challenge during the pandemic because of its negative effect on health. As a response to missing social interactions, technology with the intent to enhance communication and encourage activities have been introduced in care homes. However, there is a lack of knowledge about the introduction and use of technology. To gain insight into this, Centre for Age-Related Medicine at Stavanger University Hospital SESAM has carried out a pilot project made possible by DAM Foundation, where the smart robot Berntsen (hereinafter referred to as Berntsen) was used for video communication. The pilot project show that the use requires organizational leadership, motivated care staff and a well-organized introduction, and that there is a great need for more knowledge about these factors in order to develop a good implementation strategy.
Hence, SESAM has started the ground breaking project "RoboCare - Effectiveness, efficiency, uptake and use of a smart robot in care homes: A cluster randomized trial and implementation study" to investigate if Berntsen can reduce loneliness and social isolation, increase residents' quality of life and increase staff job satisfaction. Berntsen is an iPad on a stand with wheels or a tripod suitable for tabled tops, with content that can be customized to the user. It can promote person centred activities, tailored schedules and facilitate video communication. Berntsen can also act as a personal trainer with customized exercise videos in collaboration with a physical therapist.
This study will be part of the cluster RCT to explore which factors are important for implementation from the micro-level (person with dementia, family member and staff) perspective, and what must be set for optimal use of Berntsen in a care home.
It is of vital importance that all stakeholders are involved in an implementation process to integrate technology. These aspects are however less described in research concerning development of technological interventions in care homes. Consequently, knowledge concerning care staff, residents and informal carers is scarce.
Design: An explorative qualitative study consisting of 3 sub studies:
- A qualitative study to investigate the resident, family member and care staff perspective on implementation and use of technology in a care home setting
- A qualitative study to investigate the resident, family member and care staff experience using Berntsen as part of daily practice and for communication.
- A qualitative observational study to investigate the dynamic between people living with dementia and family member during communication through Berntsen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care staff | – | Other: No intervention |
| Residents | – | Other: No intervention |
| Family members | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be recruited from two care homes also included in the cluster RCT. For diversity purposes, we seek to include both large and smaller care homes from larger cities and rural areas and purposely include two different units from each care to reflect the variety of experiences.
Key inclusion criteria (1 listed)
- Dementia diagnosis at the time of inclusion equivalent with stage 5 (Moderately severe cognitive decline) on the Functional Assessment Staging Tool (FAST)
Key exclusion criteria (3 listed)
- Any participants who are not able to give informed consent themselves or through a consultee will not be included in the project.
- Family member
- All family members of included residents will be invited to participate in the project
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 |
|---|---|---|
| No interventionNo intervention | Other | Care staff, Family members, Residents |
Primary outcome
Hindering and promoting factors to technology implementation
Time frame: Three years
Measured using qualitative interviews with care staff, residents and family members and observation of residents and family members
3 secondary outcomes
Implementation and use of technology in a care home setting
Time frame: July - December 2022
User perspective on Berntsen
Time frame: January - June 2023
People with dementia and family member communication through Berntsen
Time frame: July - December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 29408901Ballard C, Corbett A, Orrell M, Williams G, Moniz-Cook E, Romeo R, Woods B, Garrod L, Testad I, Woodward-Carlton B, Wenborn J, Knapp M, Fossey J. Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial. PLoS Med. 2018 Feb 6;15(2):e1002500. doi: 10.1371/journal.pmed.1002500. eCollection 2018 Feb.
- Background: PubMed 31229221Barbosa Neves B, Sanders A, Kokanovic R. "It's the worst bloody feeling in the world": Experiences of loneliness and social isolation among older people living in care homes. J Aging Stud. 2019 Jun;49:74-84. doi: 10.1016/j.jaging.2019.100785. Epub 2019 Jun 6.
- Background: PubMed 29888677Ko M, Wagner L, Spetz J. Nursing Home Implementation of Health Information Technology: Review of the Literature Finds Inadequate Investment in Preparation, Infrastructure, and Training. Inquiry. 2018 Jan-Dec;55:46958018778902. doi: 10.1177/0046958018778902.
- Background: PubMed 26216463Khosravi P, Ghapanchi AH. Investigating the effectiveness of technologies applied to assist seniors: A systematic literature review. Int J Med Inform. 2016 Jan;85(1):17-26. doi: 10.1016/j.ijmedinf.2015.05.014. Epub 2015 Jun 11.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Helse Stavanger HF.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Birgitte Holteng (0047 40063238, lise.birgitte.austbo.holteng@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hindering and promoting factors to technology implementation (time frame: Three years). 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 NCT05439304, which also lists 4 linked publications.
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 30 Jun 2022; AzTrials last refreshed its copy on 29 Oct 2026.