NCT05919355

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,114

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 5, 2024

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

June 16, 2023

Last Update Submit

April 4, 2024

Conditions

Keywords

Social isolationKompCommunication technologyOsloOlder adultsHome care servicesAgeing in placeGerontechnology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Amount and type of care services received

    From enrollment and up to 24 months.

Other Outcomes (6)

  • Participants' feelings of safety

    Assessment happens at one point between enrollment and up to 18 months after.

  • Participants' social connectedness

    Assessment happens at one point between enrollment and up to 18 months after.

  • Participants' feelings of loneliness

    Assessment happens at one point between enrollment and up to 18 months after.

  • +3 more other outcomes

Study Arms (2)

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.

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.

Interventions

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

Offered to try Komp

Eligibility Criteria

Age67 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oslo Municipality, Borough 4 St. Hanshaugen

Oslo, 0130, Norway

Location

Oslo Municipality, Borough 13 Østensjø

Oslo, 0621, Norway

Location

Oslo Municipality, Borough 14 Nordstrand

Oslo, 1112, Norway

Location

MeSH Terms

Conditions

Social IsolationPsychological Well-BeingDementiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPersonal SatisfactionBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There are no other parties.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: "Intention-to-treat" (ITT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2023

First Posted

June 26, 2023

Study Start

December 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 5, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations