Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05919355 |
| Other study ID # |
202916 |
| Secondary ID |
331810 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Oslo Metropolitan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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, 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.
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.
