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Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05970315
Enrollment
45
Registered
2023-08-01
Start date
2023-07-06
Completion date
2025-06-30
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Brief summary

The purpose of this study is to compare patient priorities care (PPC) and usual care (UC) patients to identify differences in post-encounter medication changes, treatment burden (TBQ), and shared decision making in Older Patient Assessment of Chronic Illness Care (OPACIC), to understand PPC participant's sense-making and communication approaches related to deprescribing decisions in relation to the identified health priorities and to identify and categorize adverse drug withdrawal events (ADWEs)

Interventions

BEHAVIORALPPC

Participants will have an encounter with a facilitator who will identify priorities (outcome goals and care preferences) from the dyads and transmits them in the electronic health records (EHR), and a follow-up encounter with their usual geriatric care provider to decide upon changes in their care that align with the identified priorities.

BEHAVIORALUsual care

Participants will have a geriatric clinic visit with a geriatrician that acts as their primary care provider (PCP) , in which the dyads will be encouraged by an unblinded study coordinator to ask about reducing medication burden.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Dementia listed as an active problem in the medical record, including Alzheimer's disease, vascular dementia, frontotemporal dementia, Parkinson's dementia, Lewy body disease. * The functional assessment staging tool (FAST) score of 5 or lower (This will be established by the patient's clinician). * 2 or more additional chronic conditions * Takes 5 or more regular medications and * A caregiver present during visits. Caregivers may include family members or unrelated caregivers and will be identified through chart review and confirmed by clinician, patient, and surrogate decision maker if necessary. Identified caregivers must be involved in decisions and care of People living with dementia (PLWD) and routinely attend clinic visits with patient

Exclusion criteria

* FAST score of 6 or more (This will be established by the patient's clinician). * Significant hearing, vision, or advanced cognitive impairment that limits ability to participate in PPC encounters, * Caregiver is unwilling or able to participate in visits, or * Deemed ineligible by their Primary care physician (PCP)

Design outcomes

Primary

MeasureTime frameDescription
Number of medication changesBaseline, 3 month
Type of medication changesBaseline, 3 month
Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)Baseline, 3 monthThis is a 15 item questionnaire and each is scored from 0(not a problem) to 10(big problem) for a maximum score of 150, higher number indicating more burden
Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale3 monthsNaranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.
Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale3 monthsNaranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.

Secondary

MeasureTime frameDescription
Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) scoreBaseline, 3 monthsThis is a 10 item questionnaire and each is scored from 1(almost never) to 5(almost always),for a maximum score of 50 ,higher scores indicate better perceived chronic disease care

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAanand D Naik, MD

The University of Texas Health Science Center, Houston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026