Clinical trial NCT05919355: 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.
Official title: BoVEL: Bo Lenger Hjemme Med Sosial Velferdsteknologi [Live Longer at Home With Social Welfare-Technology]
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Social Isolation
Well-being
Quality of Life
Mental Health
Dementia
Older Adults
Loneliness
Safety
Feeling Anxious
Technology
Home Care
Keywords: Social isolation
Komp
Communication technology
Oslo
Older adults
Home care services
Ageing in place
Gerontechnology
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo Municipality
name: No Isolation limited
First posted: 2023-06-26
Enrollment: 1114
Sex: ALL
Minimum age (years): 67
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "Intention-to-treat" (ITT)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Number of days participants live at home
timeFrame: 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:
measure: Amount and type of care services received
timeFrame: From enrollment and up to 24 months.
Other outcomes:
measure: Participants' feelings of safety
timeFrame: Assessment happens at one point between enrollment and up to 18 months after.
measure: Participants' social connectedness
timeFrame: Assessment happens at one point between enrollment and up to 18 months after.
measure: Participants' feelings of loneliness
timeFrame: Assessment happens at one point between enrollment and up to 18 months after.
measure: Participants' self-assessed quality of life
timeFrame: Assessment happens at one point between enrollment and up to 18 months after.
measure: Participants' difficulties remembering
timeFrame: Assessment is supposed to happen routinely every three months, from enrollment and up to 18 months after.
measure: Participants' difficulties taking care of their health
timeFrame: Assessment is supposed to happen routinely every three months, from enrollment and up to 18 months after.
Locations:
city: Oslo
country: Norway
facility: Oslo Municipality, Borough 4 St. Hanshaugen
city: Oslo
country: Norway
facility: Oslo Municipality, Borough 13 Østensjø
city: Oslo
country: Norway
facility: Oslo Municipality, Borough 14 Nordstrand
Study officials:
References: