Social IsolationBoVELNCT05919355
Effectiveness of a Communication Device in Home Care Services in Norway: Does Komp Make Older Adults Feel Happier, Safer and More Connected, and Able to Live Longer at Home.
A study testing Offer to try Komp in people with Social Isolation and Well-being, run by Oslo Metropolitan University at 3 sites in Norway.
Trial summary
This study is a field trial where "Komp" is implemented and tested as part of Oslo Municipality's home care services for older adults. Komp is a "one button" communication device designed specifically for older adults who are unfamiliar with or struggle to use conventional digital technologies such as smart phones… Read more about this study
- Who is it for?
- Ages 67 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Well-being, Quality of Life
- What is being tested?
- Offer to try Komp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,114 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Dec 2022to 31 Dec 2024
- 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 67 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Must be a recipient of municipal home care services
- Must dwell in a private home (i.e., not in a permanent care or nursing home)
- Must have a registered address in one of the three burroughs
Who cannot join
- Must not score 1 on all of the following "IPLOS variables", as assessed by the municipal services: "mobility outdoors", "memory", and "cooking". IPLOS stands for Individual-based nurse and care statistics ["Individbasert pleie- og omsorgsstatistikk"], and the IPLOS variables are a set of officially sanctioned variables, the assessment of which are supposed to help municipal health and care services ascertain whether a person's performance of various functions suggests the need of assistance. Level 1 is the lowest level, meaning that there are no problems concerning this function. In a pre-study of historical data from one of the municipalities, scoring 1 on all these three variables correlated strongly with a low risk of moving to a long term care facility. By excluding them, the investigators increase the relative number of decisions to move to a long-term care facility within the study period.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Oslo Municipality, Borough 4 St. Hanshaugen
Oslo, 0130
Oslo Municipality, Borough 13 Østensjø
Oslo, 0621
Oslo Municipality, Borough 14 Nordstrand
Oslo, 1112
About this study
Official title: BoVEL: Bo Lenger Hjemme Med Sosial Velferdsteknologi [Live Longer at Home With Social Welfare-Technology]
This study is a field trial where "Komp" is implemented and tested as part of Oslo Municipality's home care services for older adults. Komp is a "one button" communication device designed specifically for older adults who are unfamiliar with or struggle to use conventional digital technologies such as smart phones, computers, or tablets. The aim of the trial is to study the effects of increased social contact with family and care services via Komp. In a randomized design, 300 Komp units will be offered to a sample of older municipal home care service recipients. By comparing the intervention group (who are offered to test Komp for free) with the control group (who receive services as usual), the study will uncover if, on average, users of Komp 1) can live longer at home than non-users, 2) have lesser need of home care services, and 3) are happier, safer, and more socially connected.
Read the detailed description
This randomized "intention-to-treat" study is a field trial where "Komp" is implemented and tested as part of Oslo Municipality's home care services for older adults.
Komp is a simple communication solution that was created by the Norwegian start-up No Isolation (ltd.) to prevent social isolation among older adults. It was designed specifically for users who are unfamiliar with or struggle to use conventional digital technologies such as smart phones, computers, or tablets. The solution consists of a screen, an app and a web-platform. The screen is a "one button" computer with a large (non-touch) screen, that can be turned on and off. As long as its on, the user can see text- or image content that have been sent to the screen from connected users, and can also receive video calls. Friends and family can connect with the screen and send pictures or messages, and make video calls, using the Komp app. Likewise, the care services can send content or make video calls using the web-based Komp platform.
The aim of the trial is to study the effects of increased social contact with family and care services via social technologies such as Komp. Specifically, the study will uncover if, on average, users of Komp 1) can live longer at home than non-users, 2) have lesser need of home care services, and 3) are happier, safer, and more socially connected. In doing so, the project will contribute systematic knowledge to facilitate evidence-based initiatives focused on social needs of older adults and the public health benefits of human interaction.
In a randomized design, 300 Komp units will be offered to a sample of older municipal home care service recipients in three Oslo boroughs. Based on the eligibility criteria (67+, recipient of municipal home care services), a recruitment list was compiled in each borough and randomized. The procedure was as follows: A search-algorithm was created to identify eligible participants. Jointly and under supervision, the boroughs applied the search-algorithm and compiled lists of service recipients. The resulting lists were then randomized under supervision. Because the three boroughs had uneven numbers of eligible inhabitants - boroughs A and B had more than twice the number of the smallest, C (N=234) - the procedure yielded disproportionately sized lists. To ensure equal chance in being offered a Komp across boroughs, the list size and number of Komp units were adjusted. C was given 60 Komp units to distribute among a randomized list of 234 eligible inhabitants, whereas boroughs A and B were each given 120 units to distribute among a randomized list of 468 of their eligible inhabitants.
Local project coordinators in each burrough systematically recruited participants by offering Komp to all names on the randomized list, working down from the top. The investigators register responses. In some instances no offer can be given, either because the participants have died or because they have moved to a care facility in the burrough or away from the burrough. In these cases, the investigators register this and move on to the next name. To avoid bias, however, these participants are included in the intervention group (as the control group will also contain participants who have died or moved during the study).
When all Komp units are distributed, or when a burrough has offered Komp to half its list, recruitment stops. All names up until then are in the intervention group; all remaining names on the list are in the control group. By comparing the intervention group (who are offered to test Komp for free) from the control group (who receive services as usual), the study will investigate if, on average, users of Komp 1) can live longer at home than non-users, 2) have lesser need of home care services, and 3) are happier, safer, and more socially connected.
- Conditions
- Social Isolation, Well-being, Quality of Life, Mental Health, Dementia, Older Adults
- Being tested
- Offer to try Komp
- Keywords
- Social isolation, Komp, Communication technology, Oslo, Older adults, Home care services, Ageing in place, Gerontechnology
- Medical subject headings
- Social Isolation, Psychological Well-Being, Dementia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offer to try KompOther
The participants are offered services using the communication solution Komp. If they accept, they will receive one unit at home.
| Study group | Role | What they receive |
|---|---|---|
| Offered to try Komp | Experimental | The intervention group consists of eligible service recipients in the three boroughs, who are given the offer to try Komp. Upon receiving the offer, the participant may take up to 14 days to decide. Participants who accept, receive a Komp and use it freely; participants who decline receive services as usual. Responses are documented. Participants who accepted the offer may at any point decide to stop and return the Komp to the municipality. The actual uses and effects of the technology, being a communication technology, depends on the actions of the app users (family and friends) and platform users (care services). The investigators record the types of use and the frequency of use, but not the actual content that is transferred (e.g., pictures are counted but not seen). The investigators can also distinguish between transfers originating from the app and the platform respectively, meaning that they can analyse the effects of private and professional use separately. Receives: Other: Offer to try Komp |
| Services as usual | No intervention | At a certain point, because the burrough runs out of Komp units to distribute or because they get halfway through the list, recruitment stops and no one else is offered to try Komp. All names on the burrough's list below this juncture are in the "services as normal" arm, which is the control group in this "intention-to-treat" trial. "Services as normal" means that the trial has no bearing on the participant (apart from having been informed about the project and being given the chance to opt out). They continue to receive needs-based services from their municipality, like they would have if there was no trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days participants live at home
The main outcome concerns the number of days elapsed from the day each participant first received municipal care services, to the day they die or move to a care facility, or when the study ends.
Measured: From the date participants were given a decision to receive home care services to the date when the participant dies, moves to a care facility, or up to a maximum of 24 months.
Secondary outcomes (1)
Amount and type of care services received
A secondary outcome measure concerns the level and type of care services the participants need. The investigators will record both the amount of time and the types of service that individual participants receive and how it correlates with Komp use.
Measured: From enrollment and up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Social IsolationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "Intention-to-treat" (ITT)
- Masking
- None (open label)
- Enrolment
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Municipality, No Isolation limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919355
- Sponsor's protocol ID
- 202916
- Other IDs
- 331810
- Acronym
- BoVEL
- Status last verified
- Nov 2023
- First submitted
- 16 Jun 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eikemo K, Malmberg-Heimonen I, Rasmussen EB, Thordardottir BSA, Toge AG, van der Wel KA. The effect of digital communication technology on older adults' formal care use in Norway: a randomized controlled trial. BMC Geriatr. 2026 Apr 11;26(1):713. doi: 10.1186/s12877-026-07322-z.
PubMed 41963815
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BoVEL: Bo Lenger Hjemme Med Sosial Velferdsteknologi [Live Longer at Home With Social Welfare-Technology]
- ClinicalTrials.gov ID
- NCT05919355
- Acronym / sponsor ID
- BoVEL / 202916
- Conditions
- Social Isolation, Well-being, Quality of Life, Mental Health, Dementia, Older Adults
- Keywords
- Social isolation, Komp, Communication technology, Oslo, Older adults, Home care services, Ageing in place, Gerontechnology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Oslo Municipality, No Isolation limited
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jun 2023 (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 is a field trial where "Komp" is implemented and tested as part of Oslo Municipality's home care services for older adults. Komp is a "one button" communication device designed specifically for older adults who are unfamiliar with or struggle to use conventional digital technologies such as smart phones, computers, or tablets. The aim of the trial is to study the effects of increased social contact with family and care services via Komp. In a randomized design, 300 Komp units will be offered to a sample of older municipal home care service recipients. By comparing the intervention group (who are offered to test Komp for free) with the control group (who receive services as usual), the study will uncover if, on average, users of Komp 1) can live longer at home than non-users, 2) have lesser need of home care services, and 3) are happier, safer, and more socially connected.
Detailed description
This randomized "intention-to-treat" study is a field trial where "Komp" is implemented and tested as part of Oslo Municipality's home care services for older adults.
Komp is a simple communication solution that was created by the Norwegian start-up No Isolation (ltd.) to prevent social isolation among older adults. It was designed specifically for users who are unfamiliar with or struggle to use conventional digital technologies such as smart phones, computers, or tablets. The solution consists of a screen, an app and a web-platform. The screen is a "one button" computer with a large (non-touch) screen, that can be turned on and off. As long as its on, the user can see text- or image content that have been sent to the screen from connected users, and can also receive video calls. Friends and family can connect with the screen and send pictures or messages, and make video calls, using the Komp app. Likewise, the care services can send content or make video calls using the web-based Komp platform.
The aim of the trial is to study the effects of increased social contact with family and care services via social technologies such as Komp. Specifically, the study will uncover if, on average, users of Komp 1) can live longer at home than non-users, 2) have lesser need of home care services, and 3) are happier, safer, and more socially connected. In doing so, the project will contribute systematic knowledge to facilitate evidence-based initiatives focused on social needs of older adults and the public health benefits of human interaction.
In a randomized design, 300 Komp units will be offered to a sample of older municipal home care service recipients in three Oslo boroughs. Based on the eligibility criteria (67+, recipient of municipal home care services), a recruitment list was compiled in each borough and randomized. The procedure was as follows: A search-algorithm was created to identify eligible participants. Jointly and under supervision, the boroughs applied the search-algorithm and compiled lists of service recipients. The resulting lists were then randomized under supervision. Because the three boroughs had uneven numbers of eligible inhabitants - boroughs A and B had more than twice the number of the smallest, C (N=234) - the procedure yielded disproportionately sized lists. To ensure equal chance in being offered a Komp across boroughs, the list size and number of Komp units were adjusted. C was given 60 Komp units to distribute among a randomized list of 234 eligible inhabitants, whereas boroughs A and B were each given 120 units to distribute among a randomized list of 468 of their eligible inhabitants.
Local project coordinators in each burrough systematically recruited participants by offering Komp to all names on the randomized list, working down from the top. The investigators register responses. In some instances no offer can be given, either because the participants have died or because they have moved to a care facility in the burrough or away from the burrough. In these cases, the investigators register this and move on to the next name. To avoid bias, however, these participants are included in the intervention group (as the control group will also contain participants who have died or moved during the study).
When all Komp units are distributed, or when a burrough has offered Komp to half its list, recruitment stops. All names up until then are in the intervention group; all remaining names on the list are in the control group. By comparing the intervention group (who are offered to test Komp for free) from the control group (who receive services as usual), the study will investigate if, on average, users of Komp 1) can live longer at home than non-users, 2) have lesser need of home care services, and 3) are happier, safer, and more socially connected.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "Intention-to-treat" (ITT)
| Arm | Type | Receives |
|---|---|---|
| Offered to try Komp | Experimental | Other: Offer to try KompThe intervention group consists of eligible service recipients in the three boroughs, who are given the offer to try Komp. Upon receiving the offer, the participant may take up to 14 days to decide. Participants who accept, receive a Komp and use it freely; participants who decline receive services as usual. Responses are documented. Participants who accepted the offer may at any point decide to stop and return the Komp to the municipality. The actual uses and effects of the technology, being a communication technology, depends on the actions of the app users (family and friends) and platform users (care services). The investigators record the types of use and the frequency of use, but not the actual content that is transferred (e.g., pictures are counted but not seen). The investigators can also distinguish between transfers originating from the app and the platform respectively, meaning that they can analyse the effects of private and professional use separately. |
| Services as usual | No intervention | –At a certain point, because the burrough runs out of Komp units to distribute or because they get halfway through the list, recruitment stops and no one else is offered to try Komp. All names on the burrough's list below this juncture are in the "services as normal" arm, which is the control group in this "intention-to-treat" trial. "Services as normal" means that the trial has no bearing on the participant (apart from having been informed about the project and being given the chance to opt out). They continue to receive needs-based services from their municipality, like they would have if there was no trial. |
Who may qualify
- Ages
- 67 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Must be a recipient of municipal home care services
- Must dwell in a private home (i.e., not in a permanent care or nursing home)
- Must have a registered address in one of the three burroughs
Key exclusion criteria (1 listed)
- Must not score 1 on all of the following "IPLOS variables", as assessed by the municipal services: "mobility outdoors", "memory", and "cooking". IPLOS stands for Individual-based nurse and care statistics ["Individbasert pleie- og omsorgsstatistikk"], and the IPLOS variables are a set of officially sanctioned variables, the assessment of which are supposed to help municipal health and care services ascertain whether a person's performance of various functions suggests the need of assistance. Level 1 is the lowest level, meaning that there are no problems concerning this function. In a pre-study of historical data from one of the municipalities, scoring 1 on all these three variables correlated strongly with a low risk of moving to a long term care facility. By excluding them, the investigators increase the relative number of decisions to move to a long-term care facility within the study period.
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 |
|---|---|---|
| Offer to try KompThe participants are offered services using the communication solution Komp. If they accept, they will receive one unit at home. | Other | Offered to try Komp |
Primary outcome
Number of days participants live at home
Time frame: From the date participants were given a decision to receive home care services to the date when the participant dies, moves to a care facility, or up to a maximum of 24 months.
The main outcome concerns the number of days elapsed from the day each participant first received municipal care services, to the day they die or move to a care facility, or when the study ends.
1 secondary outcome
Amount and type of care services received
Time frame: From enrollment and up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 41963815Eikemo K, Malmberg-Heimonen I, Rasmussen EB, Thordardottir BSA, Toge AG, van der Wel KA. The effect of digital communication technology on older adults' formal care use in Norway: a randomized controlled trial. BMC Geriatr. 2026 Apr 11;26(1):713. doi: 10.1186/s12877-026-07322-z.
- Individual participant dataSharing planned: No
Related trials for Social Isolation
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Recruiting
Does Attachment Anxiety Moderate the Influence of Social Rejection on Alcohol Use Among Young Adults?
Social Rejection, Attachement Style
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty
Recruiting
Social Connection Collective for Older Adults in Subsidized Housing
Social Isolation in Older Adults, Social Isolation or Loneliness
Not yet recruiting
Improving Diet Quality of Community-Dwelling Seniors Using a Community-Based Participatory Approach
Diet Quality, Social Isolation in Older Adults
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offer to try Komp in people with Social Isolation and Well-being, run by Oslo Metropolitan University at 3 sites in Norway.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
Results are not available in the source record.
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?
Number of days participants live at home (time frame: From the date participants were given a decision to receive home care services to the date when the participant dies, moves to a care facility, or up to a maximum of 24 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 NCT05919355, 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 5 Apr 2024.