DementiaNCT05970315
Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
A study testing PPC in people with Dementia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- PPC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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)
- Conditions
- Dementia
- Being tested
- PPC, Usual care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPCBehavioural
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.
Usual careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PPC | Experimental | Not described Receives: Behavioral: PPC |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medication changes
Measured: Baseline, 3 month
Type of medication changes
Measured: Baseline, 3 month
Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)
This 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
Measured: Baseline, 3 month
Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale
Naranjo 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.
Measured: 3 months
Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale
Naranjo 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.
Measured: 3 months
Secondary outcomes (1)
Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score
This 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
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start6 Jul 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Aanand Dinkar Naik, The University of Texas Health Science Center, Houston
- Investigators
- Aanand D Naik, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970315
- Sponsor's protocol ID
- HSC-SPH-22-0639
- Other IDs
- 5R24AG064025-05
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
- ClinicalTrials.gov ID
- NCT05970315
- Acronym / sponsor ID
- HSC-SPH-22-0639
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPC | Experimental | Behavioral: PPC |
| Usual Care | Active comparator | Behavioral: Usual care |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPCParticipants 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. | Behavioural | PPC |
| Usual careParticipants 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. | Behavioural | Usual Care |
Primary outcome
Number of medication changes
Time frame: Baseline, 3 month
Type of medication changes
Time frame: Baseline, 3 month
Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)
Time frame: Baseline, 3 month
This 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 scale
Time frame: 3 months
Naranjo 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 scale
Time frame: 3 months
Naranjo 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.
1 secondary outcome
Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aanand D Naik, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPC in people with Dementia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of medication changes (time frame: Baseline, 3 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.