DementiaIN-PEACENCT03773757
Indiana Palliative Excellence in Alzheimer's Care Efforts
A study testing IN-PEACE Dementia Care Coordination in people with Dementia, run by Indiana University at 1 site in United States.
Trial summary
The overarching goal of this research is to improve the care of community dwelling patients with dementia and their family caregivers through an innovative model of supportive care that combines an existing, evidence-based intervention for dementia care with an innovative intervention for palliative care in dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- IN-PEACE Dementia Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 7 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Inclusion Criteria: Community-dwelling and living in the Indianapolis metropolitan area; Patient with an established diagnosis of dementia of any etiology; Dementia in the moderate (FAST stage 5) to severe stage (FAST 6-7); and English-speaking Primary caregiver informant enrolled in study.
Exclusion Criteria: Patient with dementia residing in a nursing facility or receiving hospice care; Patient or Caregiver with long-standing history of severe mental illness or Psychiatric disorder preexisting the dementia diagnosis. Initially, non-English speaking patients were excluded. On April 14, 2020, Institutional Review Board (IRB) Amendment eliminated this exclusion so non-English speaking patients could be enrolled as long as their Caregiver was English-speaking and able to complete assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sandra Eskenazi Center for Brain Care Innovation
Indianapolis, Indiana, 46202
About this study
Official title: Indiana Palliative Excellence in Alzheimer's Care Efforts- Randomized Control Trial
The overarching goal of this research is to improve the care of community dwelling patients with dementia and their family caregivers through an innovative model of supportive care that combines an existing, evidence-based intervention for dementia care with an innovative intervention for palliative care in dementia. The intervention projects this care into the homes of patients and caregivers, empowering caregivers, and integrating with ongoing care. IN-PEACE will enroll 200 patient-caregiver dyads, randomizing 100 dyads each to the intervention and usual care arms and follow for 24 months with quarterly outcome assessments. The core of the multi-component intervention is regular, proactive telephone contact by a dementia care coordinator (DCC; social worker or RN) to anticipate and identify patients' symptoms and caregivers needs and address by utilizing specific, evidence-based protocols. Protocols cover basic dementia care, caregiver distress, neuropsychiatric symptoms, pain, navigating the hospital, feeding difficulties, and transition to hospice. The intervention also involves advance care planning and support with caregivers tailored to decisions faced in dementia care, highlighting where palliative care options can replace the default that often results in burdensome treatments.
The primary aim of IN-PEACE is to test the effect of the intervention on patients' neuropsychiatric symptoms. Other aims include testing the effect of IN-PEACE on patients' overall symptom outcomes, caregiver mood and distress, and the provision of burdensome treatments to patients (hospitalizations and emergency room visits).
Read the detailed description
Dementia is an increasingly prevalent, costly and burdensome condition. The dramatic aging of the US population is creating a dementia "epidemic" that our health care system is poorly prepared to handle. More than 5 million people are affected by Alzheimer's disease (AD) and related dementias in 2016, with that number estimated to nearly triple to 13.8 million by 2050. The direct health care costs alone for dementia care are projected to increase from $236 billion in 2016 to more than $1 trillion in 2050. In addition to cognitive and functional deterioration, patients with dementia experience behavioral and psychological complications such as agitation and depression. Family caregivers of patients with dementia experience higher levels of anxiety, depression, chronic fatigue, and an increased mortality risk.
Dementia and palliative care are national research priorities. Both dementia and palliative care have been identified as priority conditions for research and quality improvement by numerous organizations such as the Institute of Medicine, National Quality Forum, the Centers for Medicare and Medicaid Services, and Agency for Healthcare Research and Quality and National Institute on Aging. In addition, a workgroup developing milestones for care and support under the U.S. National Alzheimer's Plan has explicitly stated that palliative care needs to be incorporated throughout the course of caring for patients and families affected by dementia.
2.0 Rationale and Specific Aims
Aim 1: To test the effect of the IN-PEACE intervention on patients' neuropsychiatric symptoms (e.g., agitation/aggression, anxiety, repetitive behaviors). Mixed effects models will be used to compare repeated Neuropsychiatric Inventory Questionnaire (NPI-Q) scores obtained at 3, 6, 9, 12, 15, 18, 21, and 24 months. Repeatedly measured NPI-Q scores will be the dependent variable in the model.
Aim 2: To test the effect of the IN-PEACE intervention on patients' overall symptom outcomes. Analyses in this aim will use repeatedly measured Symptom Measures in End-of-Life Dementia (SM-EOLD) scores over 24 months of follow-up as the dependent variable in the mixed effects model, similarly to the approach described for Aim 1.
Aim 3: To test the effect of the IN-PEACE intervention on caregivers' distress and mood. Aim 3 analyses will use repeatedly measured caregiver NPI-Q distress scores and caregiver Patient Health Questionnaire (PHQ-9) over 24 months of follow-up as the dependent variables in separate mixed effects models, similar to the approach for Aim 1.
Aim 4: Evaluate the effect of the IN-PEACE intervention on ER/hospital use. ER/hospitalization events will be obtained from accessing electronic medical records maintained by the Indiana Health Information Exchange (IHIE) and the Indiana Network for Patient Care (INPC). Poisson regression models will be used to compare rates of any ER/hospitalization event between the two groups while adjusting for dementia severity and significant baseline variables that differ between the two groups.
- Conditions
- Dementia
- Being tested
- IN-PEACE Dementia Care Coordination
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-PEACE Dementia Care CoordinationBehavioural
Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
| Study group | Role | What they receive |
|---|---|---|
| IN-PEACE Dementia Care Coordination | Experimental | In-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. Receives: Behavioral: IN-PEACE Dementia Care Coordination |
| Usual Care | No intervention | The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity
The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms.
Measured: 0-24 months
Secondary outcomes (4)
Symptom Management - End of Life for Dementia (SM-EOLD)
The Symptom Measures in End-of-Life Dementia (SM-EOLD) measures the presence and frequency of 9 symptoms experienced by the person with dementia (PWD) in the previous 90 days per caregiver report: pain, shortness of breath, depression, fear, anxiety, agitation, calm, skin breakdown, and resistance to care. Each symptom is scored on a scale ranging 0 - 5 (daily, several days a week, once a week, 2 or 3 days a month, once a month, never) with higher scores indicating better symptom control. The SM-EOLD total score is constructed by summing the value of each item, and ranges from 0-45 with higher scores indicating better symptom control (comfort).
Measured: 0-24 months
Patient Health Questionnaire (PHQ-8) Caregiver
The Patient Health Questionnaire-8 item measures the frequency of depressive symptoms experienced by the caregiver in the last two weeks per caregiver report. Each symptom is scored on a scale of 0-3 (not at all, several days, more than half the days, nearly every day) with higher scores indicating more frequency of depressive symptoms. The PHQ-8 Caregiver total score is constructed by summing the value of each item and ranges from 0-24 with higher scores indicating more frequent depressive symptoms in the caregiver.
Measured: 0-24 months
Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress
The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. If the symptom was reported as present, then the caregiver rated the level of distress they experienced related to the patient's symptom on a scale of 0-5 with higher scores indicating more distress. The NPI-Q Caregiver Distress total score is constructed by summing the value of each distress item and ranges from 0-60 with higher scores indicating more caregiver distress.
Measured: 0-24 months
Emergency Department Visits and Hospitalizations
Combined measure of counts of emergency department (ED) visits and hospital admissions drawn from hospital reported data in the Indiana Network for Patient Care (INPC) database, managed by the Indiana Health Information Exchange (IHIE). As pre-specified, this data only includes the patient from each dyad and not the caregiver.
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start14 Mar 2019
- Primary completion7 Jan 2023
- Study completion7 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Regenstrief Institute, Inc., National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Greg Sachs, Indiana University
- Investigators
- Greg A Sachs, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773757
- Sponsor's protocol ID
- 1707549593
- Other IDs
- 1R01AG057733-01A1
- Acronym
- IN-PEACE
- Status last verified
- Jul 2024
- First submitted
- 21 Nov 2018
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
PubMed 11001602Volicer L, Hurley AC, Blasi ZV. Scales for evaluation of End-of-Life Care in Dementia. Alzheimer Dis Assoc Disord. 2001 Oct-Dec;15(4):194-200. doi: 10.1097/00002093-200110000-00005.
PubMed 11723370Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
PubMed 15550799Sachs GA, Johnson NM, Gao S, Torke AM, Hickman SE, Pemberton A, Vrobel A, Pan M, West J, Kroenke K. Palliative Care Program for Community-Dwelling Individuals With Dementia and Caregivers: The IN-PEACE Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):962-971. doi: 10.1001/jama.2024.25845.
PubMed 39878993Holtz LR, Kroenke K, Gao S, Hickman SE, Torke AM, Johnson NM, Pemberton A, Vrobel A, Pan M, Sachs GA. Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia. Contemp Clin Trials. 2023 Jul;130:107217. doi: 10.1016/j.cct.2023.107217. Epub 2023 May 4.
PubMed 37149000
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indiana Palliative Excellence in Alzheimer's Care Efforts- Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03773757
- Acronym / sponsor ID
- IN-PEACE / 1707549593
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Regenstrief Institute, Inc., National Institute on Aging (NIA)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 7 Jan 2023 (actual)
- Study completion
- 7 Jan 2023 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this research is to improve the care of community dwelling patients with dementia and their family caregivers through an innovative model of supportive care that combines an existing, evidence-based intervention for dementia care with an innovative intervention for palliative care in dementia. The intervention projects this care into the homes of patients and caregivers, empowering caregivers, and integrating with ongoing care. IN-PEACE will enroll 200 patient-caregiver dyads, randomizing 100 dyads each to the intervention and usual care arms and follow for 24 months with quarterly outcome assessments. The core of the multi-component intervention is regular, proactive telephone contact by a dementia care coordinator (DCC; social worker or RN) to anticipate and identify patients' symptoms and caregivers needs and address by utilizing specific, evidence-based protocols. Protocols cover basic dementia care, caregiver distress, neuropsychiatric symptoms, pain, navigating the hospital, feeding difficulties, and transition to hospice. The intervention also involves advance care planning and support with caregivers tailored to decisions faced in dementia care, highlighting where palliative care options can replace the default that often results in burdensome treatments.
The primary aim of IN-PEACE is to test the effect of the intervention on patients' neuropsychiatric symptoms. Other aims include testing the effect of IN-PEACE on patients' overall symptom outcomes, caregiver mood and distress, and the provision of burdensome treatments to patients (hospitalizations and emergency room visits).
Detailed description
Dementia is an increasingly prevalent, costly and burdensome condition. The dramatic aging of the US population is creating a dementia "epidemic" that our health care system is poorly prepared to handle. More than 5 million people are affected by Alzheimer's disease (AD) and related dementias in 2016, with that number estimated to nearly triple to 13.8 million by 2050. The direct health care costs alone for dementia care are projected to increase from $236 billion in 2016 to more than $1 trillion in 2050. In addition to cognitive and functional deterioration, patients with dementia experience behavioral and psychological complications such as agitation and depression. Family caregivers of patients with dementia experience higher levels of anxiety, depression, chronic fatigue, and an increased mortality risk.
Dementia and palliative care are national research priorities. Both dementia and palliative care have been identified as priority conditions for research and quality improvement by numerous organizations such as the Institute of Medicine, National Quality Forum, the Centers for Medicare and Medicaid Services, and Agency for Healthcare Research and Quality and National Institute on Aging. In addition, a workgroup developing milestones for care and support under the U.S. National Alzheimer's Plan has explicitly stated that palliative care needs to be incorporated throughout the course of caring for patients and families affected by dementia.
2.0 Rationale and Specific Aims
Aim 1: To test the effect of the IN-PEACE intervention on patients' neuropsychiatric symptoms (e.g., agitation/aggression, anxiety, repetitive behaviors). Mixed effects models will be used to compare repeated Neuropsychiatric Inventory Questionnaire (NPI-Q) scores obtained at 3, 6, 9, 12, 15, 18, 21, and 24 months. Repeatedly measured NPI-Q scores will be the dependent variable in the model.
Aim 2: To test the effect of the IN-PEACE intervention on patients' overall symptom outcomes. Analyses in this aim will use repeatedly measured Symptom Measures in End-of-Life Dementia (SM-EOLD) scores over 24 months of follow-up as the dependent variable in the mixed effects model, similarly to the approach described for Aim 1.
Aim 3: To test the effect of the IN-PEACE intervention on caregivers' distress and mood. Aim 3 analyses will use repeatedly measured caregiver NPI-Q distress scores and caregiver Patient Health Questionnaire (PHQ-9) over 24 months of follow-up as the dependent variables in separate mixed effects models, similar to the approach for Aim 1.
Aim 4: Evaluate the effect of the IN-PEACE intervention on ER/hospital use. ER/hospitalization events will be obtained from accessing electronic medical records maintained by the Indiana Health Information Exchange (IHIE) and the Indiana Network for Patient Care (INPC). Poisson regression models will be used to compare rates of any ER/hospitalization event between the two groups while adjusting for dementia severity and significant baseline variables that differ between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN-PEACE Dementia Care Coordination | Experimental | Behavioral: IN-PEACE Dementia Care CoordinationIn-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. |
| Usual Care | No intervention | –The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| IN-PEACE Dementia Care CoordinationPatient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia. | Behavioural | IN-PEACE Dementia Care Coordination |
Primary outcome
Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity
Time frame: 0-24 months
The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms.
4 secondary outcomes
Symptom Management - End of Life for Dementia (SM-EOLD)
Time frame: 0-24 months
Patient Health Questionnaire (PHQ-8) Caregiver
Time frame: 0-24 months
Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress
Time frame: 0-24 months
Emergency Department Visits and Hospitalizations
Time frame: 0-24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 11001602Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
- Results publication: PubMed 11723370Volicer L, Hurley AC, Blasi ZV. Scales for evaluation of End-of-Life Care in Dementia. Alzheimer Dis Assoc Disord. 2001 Oct-Dec;15(4):194-200. doi: 10.1097/00002093-200110000-00005.
- Results publication: PubMed 15550799Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
- Derived from this study: PubMed 39878993Sachs GA, Johnson NM, Gao S, Torke AM, Hickman SE, Pemberton A, Vrobel A, Pan M, West J, Kroenke K. Palliative Care Program for Community-Dwelling Individuals With Dementia and Caregivers: The IN-PEACE Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):962-971. doi: 10.1001/jama.2024.25845.
- Derived from this study: PubMed 37149000Holtz LR, Kroenke K, Gao S, Hickman SE, Torke AM, Johnson NM, Pemberton A, Vrobel A, Pan M, Sachs GA. Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia. Contemp Clin Trials. 2023 Jul;130:107217. doi: 10.1016/j.cct.2023.107217. Epub 2023 May 4.
- 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.
Greg A Sachs, MD principal investigator
Indiana 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 IN-PEACE Dementia Care Coordination in people with Dementia, run by Indiana 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?
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 27 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity (time frame: 0-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773757, which also lists 5 linked publications.
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 27 Aug 2024.