Evidence map›Paper›PMID 32320844›Full record

ArticleContemporary clinical trials2020

Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers.

Alycia A Bristol, Kimberly A Convery, Victor Sotelo, Catherine E Schneider, Shih-Yin Lin, Jason Fletcher, Randall Rupper, James E Galvin, Abraham A Brody

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03255967 (A Multisite Cluster RCT of the Dementia Symptom Management at Home Program), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03255967 nacompletednot on this map

A Multisite Cluster RCT of the Dementia Symptom Management at Home Program

TypeinterventionalSponsorNYU Langone HealthRan2018 to 2022Enrolled217ConditionsDementiaArmsDSM-H, Standard of Care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Aliviado Mobile App for Hospice Providers: A Usability Study.Journal of pain and symptom management · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Alycia A BristolNYU Rory Meyers College of Nursing, United States.
Kimberly A ConveryThe Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.
Victor SoteloThe Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.
Catherine E SchneiderNYU Rory Meyers College of Nursing, United States.
Shih-Yin LinNYU Rory Meyers College of Nursing, United States.
Jason FletcherNYU Rory Meyers College of Nursing, United States.
Randall RupperUniversity of Utah School of Medicine, United States; George E. Wahlen Department of Veterans Affairs Medical Center, VA Salt Lake City Health Care System, Geriatric Research, Education and Clinical Center, Salt Lake City, UT, United States.
James E GalvinComprehensive Center for Brain Health, University of Miami Miller School of Medicine, United States.
Abraham A BrodyThe Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States. Electronic address: Ab.Brody@nyu.edu.

Funding

The Hospice Advanced dementia Symptom Management and Quality of Life Trial (HAS-QOL)R33AG061904 · NIA · NEW YORK UNIVERSITY · PI BRODY, ABRAHAM AIZER · 2019 to 2022
$5.1M
A Multi-Site Cluster RCT of the Dementia Symptom Management At Home ProgramR01AG056610 · NIA · NEW YORK UNIVERSITY · PI BRODY, ABRAHAM AIZER · 2017 to 2021
$3.7M
NIA NIH HHS R01 AG056610NIA NIH HHS R33 AG061904
6 · The paper itself

Abstract

introductionPersons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD.

interventionThis protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies.

methodsThis embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization.

conclusionThis study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.

trial registrationClinical Trials.gov: NCT03255967.

Indexed as

Alzheimer DiseaseCaregiversHealth EducationQuality of LifeAdaptation, PsychologicalAnalgesicsAntipsychotic AgentsCaregiver BurdenDementiaDepressionEmergency Service, HospitalHealth ServicesHealth StatusHome Care AgenciesHumansMental HealthAnalgesicsAntipsychotic AgentsBehavioral and psychological symptoms of dementiaDementiaHome healthcareInformal caregiversPragmatic clinical trialQuality of life

Identifiers

PMID32320844
PMCPMC7269690

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.