跳至主要内容
临床试验/NCT05919355
NCT05919355Unknown不适用

BoVEL: Bo Lenger Hjemme Med Sosial Velferdsteknologi [Live Longer at Home With Social Welfare-Technology]

Oslo Metropolitan University6 个研究点 分布在 1 个国家目标入组 1,114 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,114
试验地点
6
主要终点
Number of days participants live at home

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

There are no other parties.

入排标准

年龄范围
67 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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.

结局指标

主要结局

Number of days participants live at home

时间窗: 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.

次要结局

  • Amount and type of care services received(From enrollment and up to 24 months.)

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Sponsor

研究点 (6)

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