NCT04175977

The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)

Completed NA Last updated 19 December 2024

What this trial tests

NA trial testing Aliviado Dementia Care-Hospice Edition QAPI program in Dementia in 44,143 participants. Completed in 13 August 2024.

Timeline

1 January 2020

Primary endpoint
13 August 2024

13 August 2024

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	supportive care
Enrollment	44,143
Start date	1 January 2020
Primary completion	13 August 2024
Estimated completion	13 August 2024
Sites	1 location across United States

Drugs / interventions tested

• Aliviado Dementia Care-Hospice Edition QAPI program
• Usual Care

Conditions studied

• Dementia — all drugs for Dementia →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Aliviado Dementia Care Program (formerly known as the Dementia Symptom Management at Home Program, or DSM-H) was developed to implement dementia friendly care for persons with Dementia and their caregivers living in the community. Aliviado Dementia Care-Hospice Edition is a systems level quality assurance performance improvement program that includes interdisciplinary team training, validated assessment instruments, patient-centered care plans, treatment algorithms for behavioral and psychological symptoms of dementia and terminal delirium, and caregiver education pamphlets. Utilizing the R61/R33 mechanism, the Aliviado Dementia Care-Hospice Edition was successfully implemented in 2 sequential pilot trials in the hospice setting in 2019 (R61 phase). Following the successful pilot trials and the attainment of the R61 milestones, the investigators now seek to test the effectiveness of Aliviado Dementia Care-Hospice Edition in a pragmatic RCT in 25 hospice agencies across the nation (R33 phase) on its ability to reduce antipsychotic use (primary outcome) and effect quality (secondary and exploratory outcomes).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial.
   Lin SY, Schneider CE, Bristol AA, Clancy M, et al · · 2022 · cited 14× · PMID 33377138 · DOI 10.1093/geront/gnaa220
2. Potential sources of moral distress during COVID-19: Perspectives of hospice interdisciplinary teams.
   Jones T, Lin SY, Durga A, Luth EA, et al · · 2023 · cited 4× · PMID 35574710 · DOI 10.1017/s1478951522000633
3. A Pilot Observational Exploratory Study of Well-Being in Hospice Interdisciplinary Team Members.
   Schneider C, Bristol A, Ford A, Lin SY, et al · · 2022 · cited 2× · PMID 35164534 · DOI 10.1177/10499091211023480
4. Aliviado Mobile App for Hospice Providers: A Usability Study.
   David D, Lin SY, Groom LL, Ford A, et al · · 2022 · cited 2× · PMID 34389414 · DOI 10.1016/j.jpainsymman.2021.07.019
5. Supporting dementia family care partners during COVID-19: Perspectives from hospice staff.
   Lin SY, Jones T, David D, Lassell RKF, et al · · 2022 · cited 1× · PMID 36030641 · DOI 10.1016/j.gerinurse.2022.08.003