Caregiver BurdenSTELLA-RNCT06460012
Support Via Technology: Living and Learning With Advancing Dementia-REVISED
A study testing STELLA-R Curriculum, Unrestricted Access and Limited Access in people with Caregiver Burden, run by Oregon Health and Science University at 1 site in United States.
Trial summary
STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that are common in many types of dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- STELLA-R Curriculum, Unrestricted Access and Limited Access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult caring for family member with ADRD
- Age of 18 years or older
- Speaks and understands English to be able to participate in intervention
- Owns a telephone (smartphone, cell phone or landline)
- Has email and mailing address to receive study materials and surveys
- Provides informed consent to participate in the research
- Lives in Oregon, Washington or Idaho
- Identifies two or more behavioral symptoms that are distressing to them (care partner)
Who cannot join
- Vision problems severe enough to prevent participation
- Unwilling or unable to adequately follow study instructions and participate in study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University, Layton Aging and Alzheimer's Disease Research Center
Portland, Oregon, 97239
Allison Lindauer, PhD, 503-494-6976, lindauer@ohsu.edu
Allison Lindauer, PhD
About this study
STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that are common in many types of dementia. The curriculum instructs care partners to use the ABC approach, a cognitive behavioral technique that teaches care partners to describe a Behavior, then consider the Activators and Consequences of a care recipient behavior. The goal of this intervention is to reduce care partner burden and decrease reactivity to upsetting behaviors.
Read the detailed description
Providing care for a family member with Alzheimer's disease and related dementias (ADRD, aka, "dementia") is both rewarding and risky. Care partners exposed to chronic stress, often over years, are susceptible to physical and psychological ailments. Dementia involves neurodegeneration and those affected typically depend on family members for support and physical care. The "care partners" for those with dementia often experience concerning psychological and physical outcomes due to the demands of caregiving. No matter what type of dementia, most care partners experience some burden. The burden is often related to the behavioral symptoms that most people with dementia experience.
Care partners for those with dementia experience burden, grief, exhaustion and physical ailments. Programs for these care partners are more available. Effective interventions that reduce care partner burden and health risks are also available, but various factors impede participation, including distance, cost, behavioral symptoms of dementia, stigma and social anxiety. Recognizing the need to reduce barriers to access, scientists have turned to internet-based interventions.
The STELLA suite of research studies addresses the need for easily accessible, effective interventions designed to reduce burden in care partners for those with dementia. These studies examine the acceptability, feasibility, and efficacy of interventions modeled on Teri's psychoeducational behavior change intervention. We have completed two pilot studies for care partners for those with dementia using interventions with the STELLA-R precursor. These studies found early efficacy and acceptability for the intervention. We are currently testing a STELLA intervention which uses objective, technology-based assessments (OHSU IRB # 19306) and another, larger study which tests a STELLA intervention with a large national sample (OHSU IRB # 22288; NIA R01AG067546). In addition, with funding from the Association for Frontotemporal Degeneration (AFTD) we tested a similar intervention (STELLA-FTD) for care partners caring for a family member with frontotemporal dementia (OHSU IRB # 22721).
In all STELLA studies care partners work with professional guides to use the ABC analytic approach to describe a distressing behavior, then identify its activators and consequences. With this information, care partners can develop plans to reduce behavioral symptoms. In this proposed study, we will assess an online version of Tele-STELLA.
STELLA-R is informed by the World Health Organization (WHO) guidance to include rehabilitation science in dementia care to facilitate effective management of the advancing behavioral, communication, physical and social changes that come with progressive neurodegenerative dementias (e.g., Alzheimer's disease, frontotemporal degeneration, Lewy Body dementia). Grounded in self-efficacy theory and foundational research, STELLA-R will train care partners to address current behavioral symptoms and prepare for future ones.
The specific aims of this study are:
Aim 1. Assess feasibility and acceptability of STELLA-R
Aim 2. Compare the efficacy of STELLA-R in reducing care partner reactivity to dementia-related behavioral symptoms between two groups.
- Conditions
- Caregiver Burden
- Being tested
- STELLA-R Curriculum, Unrestricted Access, Limited Access
- Keywords
- caregivers, dementia, RMBPC, caregiver support
- Medical subject headings
- Caregiver Burden, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STELLA-R CurriculumBehavioural
The STELLA-R curriculum is presented utilizing the ABC analytic approach to address care recipient's distressing behaviors. Using the scaffold of the ABC pyramid, they will receive video instructions on how to fully define the Behaviors they want to address by observing, describing, and writing about them. The care partners will learn to identify the Activators, the triggers for the behaviors. Next, care partners will learn to consider what happens after the behaviors, the Consequences. This is an 8-week self-directed, online weekly curriculum.
Unrestricted AccessBehavioural
Also called Post-Intervention Phase, Review Phase
Following the STELLA-R curriculum, care partners will receive 8 weeks of unrestricted access to all lessons and resources.
Limited AccessBehavioural
Also called Restricted Access
Experimental and Waitlist Control group will experience 8 consecutive weeks of limited access to the STELLA-R website and resources. Waitlist Control will experience this from Week 1 to Week 8 while the Experimental Group will reach this phase from Week 17 to Week 24.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Care partners start the STELLA-R Curriculum immediately after enrollment. Receives: Behavioral: STELLA-R Curriculum; Behavioral: Unrestricted Access; Behavioral: Limited Access |
| Waitlist Control Group | Active comparator | Care partners start the STELLA-R Curriculum 8 weeks after enrollment. Receives: Behavioral: STELLA-R Curriculum; Behavioral: Unrestricted Access; Behavioral: Limited Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Memory and Behavior Problems Checklist (RMBPC)
The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms.
The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.
Measured: Week 1, Week 8, Week 16, Week 24
Feasibility of STELLA-R Intervention
We will assess the feasibility of implementing STELLA-R across Oregon, Washington and Idaho. We will analyze metadata from the STELLA-R website to assess care partner usage of intervention materials. We will assess data from the surveys to characterize the sample, assess program acceptability, and measure treatment fidelity. We will compare demographic information, computer use, health-care usage, behavioral symptom frequency, medication use, care partner reactivity, burden and depression.
Measured: 10 months
Acceptability of STELLA-R Intervention
For acceptability, we will utilize the STELLA-R Experience Survey which is a 16-item survey on satisfaction, privacy, and ease of use. We will analyze the STELLA-R Experience Survey results using descriptive statistics. We will identify themes of acceptance, or lack thereof, of STELLA-R and the underpinnings of their impressions.
Measured: Week 24
Secondary outcomes (13)
Fortinsky's Measurement of Family Care Partner Self-Efficacy for Managing Dementia
Self-efficacy, the mediating variable, will be assessed using Fortinsky's measurement of family care partner self-efficacy for managing dementia. Fortinsky's assess the targets in STELLA-R: behavior symptom management and service use.
Fortinsky's measurement is a 9-item Likert scale ranging from 1 (not at all certain) to 10 (very certain). Higher scores are associated with fewer depressive symptoms and fewer physical health symptoms.
Measured: Week 1, Week 8, Week 16, Week 24
Preparedness for Caregiving Scale
The Preparedness for Caregiving Scale is a 10-item Likert scale ranging from 0 (not at all prepared) to 4 (very well prepared). We will measure care partner preparedness for current and future challenges to test the effect of a group-based intervention.
Measured: Week 1, Week 8, Week 16, Week 24
Ten-Item Personality Inventory (TIPI)
The Ten-Item Personality Inventory is a 10-item Likert scale measure to assess introversion and extraversion. Choices range from 1 (disagree strongly) to 7 (agree strongly) with reverse scoring on items 2, 4, 6, 8 and 10. Scoring on items are as follows: extraversion: 1, 6R; agreeableness: 2R, 7; conscientiousness: 3, 8R; emotional stability: 4R, 9; openness to experiences: 5, 10R. We will use this measure to test the effect of a group-based intervention.
Measured: Week 1
Personalized Target Behavior Survey
The Personalized Target Behavior Survey measure frequency and reactivity of up to 3 personalized behaviors identified by care partners. We will collect data on the number of ABC plans each care partner writes on the Orbit weekly survey and the STELLA-R website.
Measured: Week 1, Week 8
Emotional and Physical Strain
The Orbit weekly survey will measure emotional and physical strain for caregivers.
Measured: Weekly for 6 months
Healthcare Use
The Orbit weekly survey will measure service use and medication use for behavioral symptoms.
Measured: Weekly for 6 months
Zarit Burden Interview
The Orbit weekly survey will include the Zarit Burden Interview, a 4-item caregiver report measuring care partner burden. This measure is a 5-point Likert scale with a range of 0 (never) to 4 (nearly always) with higher scores meaning greater burden.
Measured: Weekly for 6 months
The Neuropsychiatric Inventory (NPI-Q)
The NPI-Q with Caregiver Self-Efficacy Scale evaluates 12 behavioral disturbances in dementia. Each domain captures severity of BPSD and caregiver self-efficacy. Severity is rated 1 (mild) to 3 (severe) and self-efficacy is reverse scored from 4 (not at all confident) to 1 (very confident). This measure assesses self-efficacy in addressing specific behavioral symptoms.
Measured: Week 1, Week 8, Week 16, Week 24
Placement Plan Scale
1-item Likert scale assessment of plans for placement of family member with dementia. Care partners will rate their likelihood of moving their family member with dementia to another living arrangement from 1 (not at all likely) to 5 (very likely).
Measured: Week 1, Week 8, Week 16, Week 24
Use of Professional Services
A 7-item binary assessment of professional services used to address their family member with dementia's needs in the past 2 months. Care partners will answer Yes or No to using a: dietitian, elder care attorney, occupational therapist, physical therapist, psychologist, social worker, speech therapist, and healthcare professional.
Measured: Week 1, Week 8, Week 16, Week 24
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
A 12-item assessment measuring mindfulness, distress, well-being, emotion-regulation, and problem-solving approaches. A Likert scale ranging from 1 (rarely/not at all) to 4 (almost always) with reverse scoring on items 2, 6 and 7.
Measured: Week 1, Week 24
Pittsburgh Sleep Quality Index (PSQI)
The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available) that assesses self-rated sleep quality and disturbances over a 1-month time interval. Only self-rated questions are included in scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. A score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points. "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Measured: Week 1, Week 24
ABC Plans
A 1-item measure to assess total quantity of ABC plans created. Options are 1 (1-3), 2 (4-6), 3 (7-9) or 4 (10 or more). Experimental group completes this measure on weeks 8, 16 and 24. Wait-list control group completes this measure on weeks 16 and 24.
Measured: Week 8, Week 16, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start2 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Care partners will participate in a self-directed, 8-week online course via the STELLA-R website, followed by 8-weeks of unrestricted access to the website, with 8 weeks of restricted access. One group will receive the 8-week online course followed by the 8-week unrestricted access immediately after enrolling. The other group will receive the 8-week online course and 8-week unrestricted access 2 months after enrolling.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hart Family Foundation
- Responsible party
- Principal investigator, Allison Lindauer, Oregon Health and Science University
- Investigators
- Allison Lindauer, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460012
- Sponsor's protocol ID
- STUDY00025741
- Acronym
- STELLA-R
- Status last verified
- Oct 2025
- First submitted
- 4 Jun 2024
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be available upon request to our Alzheimer's Disease Research Center.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Via Technology: Living and Learning With Advancing Dementia-REVISED
- ClinicalTrials.gov ID
- NCT06460012
- Acronym / sponsor ID
- STELLA-R / STUDY00025741
- Conditions
- Caregiver Burden
- Keywords
- caregivers, dementia, RMBPC, caregiver support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- The Hart Family Foundation
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jun 2024 (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.
STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that are common in many types of dementia. The curriculum instructs care partners to use the ABC approach, a cognitive behavioral technique that teaches care partners to describe a Behavior, then consider the Activators and Consequences of a care recipient behavior. The goal of this intervention is to reduce care partner burden and decrease reactivity to upsetting behaviors.
Detailed description
Providing care for a family member with Alzheimer's disease and related dementias (ADRD, aka, "dementia") is both rewarding and risky. Care partners exposed to chronic stress, often over years, are susceptible to physical and psychological ailments. Dementia involves neurodegeneration and those affected typically depend on family members for support and physical care. The "care partners" for those with dementia often experience concerning psychological and physical outcomes due to the demands of caregiving. No matter what type of dementia, most care partners experience some burden. The burden is often related to the behavioral symptoms that most people with dementia experience.
Care partners for those with dementia experience burden, grief, exhaustion and physical ailments. Programs for these care partners are more available. Effective interventions that reduce care partner burden and health risks are also available, but various factors impede participation, including distance, cost, behavioral symptoms of dementia, stigma and social anxiety. Recognizing the need to reduce barriers to access, scientists have turned to internet-based interventions.
The STELLA suite of research studies addresses the need for easily accessible, effective interventions designed to reduce burden in care partners for those with dementia. These studies examine the acceptability, feasibility, and efficacy of interventions modeled on Teri's psychoeducational behavior change intervention. We have completed two pilot studies for care partners for those with dementia using interventions with the STELLA-R precursor. These studies found early efficacy and acceptability for the intervention. We are currently testing a STELLA intervention which uses objective, technology-based assessments (OHSU IRB # 19306) and another, larger study which tests a STELLA intervention with a large national sample (OHSU IRB # 22288; NIA R01AG067546). In addition, with funding from the Association for Frontotemporal Degeneration (AFTD) we tested a similar intervention (STELLA-FTD) for care partners caring for a family member with frontotemporal dementia (OHSU IRB # 22721).
In all STELLA studies care partners work with professional guides to use the ABC analytic approach to describe a distressing behavior, then identify its activators and consequences. With this information, care partners can develop plans to reduce behavioral symptoms. In this proposed study, we will assess an online version of Tele-STELLA.
STELLA-R is informed by the World Health Organization (WHO) guidance to include rehabilitation science in dementia care to facilitate effective management of the advancing behavioral, communication, physical and social changes that come with progressive neurodegenerative dementias (e.g., Alzheimer's disease, frontotemporal degeneration, Lewy Body dementia). Grounded in self-efficacy theory and foundational research, STELLA-R will train care partners to address current behavioral symptoms and prepare for future ones.
The specific aims of this study are:
Aim 1. Assess feasibility and acceptability of STELLA-R
Aim 2. Compare the efficacy of STELLA-R in reducing care partner reactivity to dementia-related behavioral symptoms between two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Care partners will participate in a self-directed, 8-week online course via the STELLA-R website, followed by 8-weeks of unrestricted access to the website, with 8 weeks of restricted access. One group will receive the 8-week online course followed by the 8-week unrestricted access immediately after enrolling. The other group will receive the 8-week online course and 8-week unrestricted access 2 months after enrolling.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: STELLA-R Curriculum, Behavioral: Unrestricted Access, Behavioral: Limited AccessCare partners start the STELLA-R Curriculum immediately after enrollment. |
| Waitlist Control Group | Active comparator | Behavioral: STELLA-R Curriculum, Behavioral: Unrestricted Access, Behavioral: Limited AccessCare partners start the STELLA-R Curriculum 8 weeks after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult caring for family member with ADRD
- Age of 18 years or older
- Speaks and understands English to be able to participate in intervention
- Owns a telephone (smartphone, cell phone or landline)
- Has email and mailing address to receive study materials and surveys
Key exclusion criteria (2 listed)
- Vision problems severe enough to prevent participation
- Unwilling or unable to adequately follow study instructions and participate in study procedures
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 |
|---|---|---|
| STELLA-R CurriculumThe STELLA-R curriculum is presented utilizing the ABC analytic approach to address care recipient's distressing behaviors. Using the scaffold of the ABC pyramid, they will receive video instructions on how to fully define the Behaviors they want to address by observing, describing, and writing about them. The care partners will learn to identify the Activators, the triggers for the behaviors. Next, care partners will learn to consider what happens after the behaviors, the Consequences. This is an 8-week self-directed, online weekly curriculum. | Behavioural | Experimental Group, Waitlist Control Group |
| Unrestricted AccessAlso: Post-Intervention Phase, Review PhaseFollowing the STELLA-R curriculum, care partners will receive 8 weeks of unrestricted access to all lessons and resources. | Behavioural | Experimental Group, Waitlist Control Group |
| Limited AccessAlso: Restricted AccessExperimental and Waitlist Control group will experience 8 consecutive weeks of limited access to the STELLA-R website and resources. Waitlist Control will experience this from Week 1 to Week 8 while the Experimental Group will reach this phase from Week 17 to Week 24. | Behavioural | Experimental Group, Waitlist Control Group |
Primary outcome
Revised Memory and Behavior Problems Checklist (RMBPC)
Time frame: Week 1, Week 8, Week 16, Week 24
The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.
Feasibility of STELLA-R Intervention
Time frame: 10 months
We will assess the feasibility of implementing STELLA-R across Oregon, Washington and Idaho. We will analyze metadata from the STELLA-R website to assess care partner usage of intervention materials. We will assess data from the surveys to characterize the sample, assess program acceptability, and measure treatment fidelity. We will compare demographic information, computer use, health-care usage, behavioral symptom frequency, medication use, care partner reactivity, burden and depression.
Acceptability of STELLA-R Intervention
Time frame: Week 24
For acceptability, we will utilize the STELLA-R Experience Survey which is a 16-item survey on satisfaction, privacy, and ease of use. We will analyze the STELLA-R Experience Survey results using descriptive statistics. We will identify themes of acceptance, or lack thereof, of STELLA-R and the underpinnings of their impressions.
13 secondary outcomes
Fortinsky's Measurement of Family Care Partner Self-Efficacy for Managing Dementia
Time frame: Week 1, Week 8, Week 16, Week 24
Preparedness for Caregiving Scale
Time frame: Week 1, Week 8, Week 16, Week 24
Ten-Item Personality Inventory (TIPI)
Time frame: Week 1
Personalized Target Behavior Survey
Time frame: Week 1, Week 8
Emotional and Physical Strain
Time frame: Weekly for 6 months
Healthcare Use
Time frame: Weekly for 6 months
Zarit Burden Interview
Time frame: Weekly for 6 months
The Neuropsychiatric Inventory (NPI-Q)
Time frame: Week 1, Week 8, Week 16, Week 24
Placement Plan Scale
Time frame: Week 1, Week 8, Week 16, Week 24
Use of Professional Services
Time frame: Week 1, Week 8, Week 16, Week 24
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time frame: Week 1, Week 24
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 1, Week 24
ABC Plans
Time frame: Week 8, Week 16, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: Yes. De-identified IPD will be available upon request to our Alzheimer's Disease Research Center.
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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.
Allison Lindauer, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STELLA-R Curriculum, Unrestricted Access and Limited Access in people with Caregiver Burden, run by Oregon Health and Science University 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Lindauer, PhD ((503) 449-8151, lindauer@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Memory and Behavior Problems Checklist (RMBPC) (time frame: Week 1, Week 8, Week 16, Week 24). The study lists 3 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 23 Oct 2025.