NCT05550727Fut, nem toboroz
The PorchLight Project
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 2.
Rövid összefoglaló (regiszter, angolul)
The proposed project is a fully embedded pragmatic trial (R01), following an R61 pilot collaboration with Lutheran Social Service of Minnesota (LSS-MN). For this project: a) the training program for Senior Companions that was developed in the R61 Phase will now be delivered as part of a routine onboarding process provided by LSS-MN to all senior support volunteers in half of their program regions across Minnesota; LSS-MN will offer the PorchLight Project program to all regions and volunteers in the state during the final months of the proposed NIA project, consistent with quality improvement approaches; and b) LSS-MN will administer regular surveys to volunteers, clients, and caregivers as part of ongoing tracking and quality improvement efforts. The University of Minnesota investigators will not collect data nor administer training, as these activities will be fully integrated into the workflow of LSS-MN. [Note: Since it was learned that caregivers receiving services/affiliated with LSS-MN programming who receive surveys are for the most part not providing care to LSS-MN clients, as of fall 2024, UMN will no longer request and analyze data on LSS-MN caregivers.] UNIVERSITY OF MINNESOTA INVOLVEMENT: The University of Minnesota and collaborating investigators outside of LSS-MN will only 1) assist in survey item selection, 2) randomize the LSS-MN regions for the initial phases of the real-world trial for evaluation purposes, 3) analyze the de-identified data shared by LSS-MN, and 4) disseminate the project results in scientific, practice, and policy outlets/contexts.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 342 (tervezett)
- Első benyújtás
- 2022. aug. 8.
- Kezdés
- 2022. szept. 23.
- Elsődleges befejezés
- 2027. jan. 31.
- Fő szponzor
- University of Minnesota
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT05550727
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 342
- 2022. szept. 23. és az elsődleges befejezés (2027. jan. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Életkor
- Please note: Due to the eligibility criteria for volunteers and clients in the LSS-MN program, we do not anticipate any data for those under 18 years of age.
Egyéb
- As data is made available, the UMN research team expects to receive survey data from all the clients and volunteers in LSS-MN Caregiver \& Companion Services programming who complete the surveys, and those included in the LSS database. Since LSS-MN administers surveys to every client and volunteer involved in their LSS-MN Caregiver \& Companion program (as able), data likely will be obtained from individuals who do not meet the memory-specific criteria. However, as needed, UMN may choose to exclude one or more of the following from analysis. Again, the researcher/research staff best judgement will be used when conducting analyses and will document decisions accordingly:
- ● Clients who do not have memory loss
- In addition, any client and volunteer can choose to not complete surveys, so we would not have survey data from those individuals, and may continue with routine attempts at surveying at the next data collection time-point. Missing surveys may be considered during analysis.
Kiket keres a vizsgálat
- In keeping with the incorporation of pragmatic design elements, the eligibility criteria of volunteers and persons with AD/ADRD is deliberately lax in order to best reflect LSS-MN "routine practice." Participants must be either a volunteer or client involved in the LSS-MN standard Caregiver \& Companion Program service programs. Programmatic and survey data on the volunteers, clients, and proxies involved will be shared with the UMN team. While all data received may be analyzed (see analysis section below), data analysis is expected to focus on those who meet the following additional criteria:
- Volunteers who are listed in the LSS database.
- Clients with cognitive concerns (i.e. minor confusion, memory loss, diagnosis for their memory loss, or concerns about cognition) via the LSS-MN surveys and/or the LSS-MN CRM database.
- If memory loss is indicated via the database or survey, it will be assumed that the client has memory loss, even if there are discrepancies. Due to the nature of the data, we expect discrepancies to exist and will document other decisions made during analysis.
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Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Minnesota (with Lutheran Social Service of Minnesota) | Minneapolis | Egyesült Államok | Ismeretlen állapot |
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