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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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1114
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 67 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Offer to try Komp
The participants are offered services using the communication solution Komp. If they accept, they will receive one unit at home.

Locations

Country Name City State
Norway Oslo Municipality, Borough 13 Østensjø Oslo
Norway Oslo Municipality, Borough 14 Nordstrand Oslo
Norway Oslo Municipality, Borough 4 St. Hanshaugen Oslo

Sponsors (3)

Lead Sponsor Collaborator
Oslo Metropolitan University No Isolation limited, Oslo Municipality

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Participants' feelings of safety Participants are asked to self-assess their feelings of safety using a standardized scale. Assessment happens at one point between enrollment and up to 18 months after.
Other Participants' social connectedness Participants' level and satisfaction with their social contentedness are measured using a standardized scale. In addition, the activity on the Komp is measured for Komp users. Assessment happens at one point between enrollment and up to 18 months after.
Other Participants' feelings of loneliness Participants are asked to self-assess their feelings of loneliness using a standardized scale. Assessment happens at one point between enrollment and up to 18 months after.
Other Participants' self-assessed quality of life Participants are asked to self-assess their overall quality of life using a standardized scale. Assessment happens at one point between enrollment and up to 18 months after.
Other Participants' difficulties remembering Care service providers are routinely asked to assess how much service recipients struggle to remember everyday things, on a scale of 1-5. The investigators will compare measures over time. Assessment is supposed to happen routinely every three months, from enrollment and up to 18 months after.
Other Participants' difficulties taking care of their health Care service providers are routinely asked to assess how much service recipients struggle to take care of their health, on a scale of 1-5. The investigators will compare measures over time. Assessment is supposed to happen routinely every three months, from enrollment and up to 18 months after.
Primary 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. 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 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. From enrollment and up to 24 months.
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