Normal Pressure HydrocephalusNPHNCT06426004
Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland
A study testing patients will receive NPH education, primary care physicians (PCPs) will receive professional NPH education and A community health worker will assist PCP in people with Normal Pressure Hydrocephalus and Hakim Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial summary
The study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race, with a focus on the Black community. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Pressure Hydrocephalus, Hakim Syndrome
- What is being tested?
- patients will receive NPH education, primary care physicians (PCPs) will receive professional NPH education and A community health worker will assist PCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2027to 30 Mar 2032
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- People over 65 years old who have completed the Annual Wellness Survey (AWV) survey
- have a clinical profile in the Hopkins Epic data sets
- live in Maryland
Who cannot join
- People under 65 years old will be excluded if they have not completed the AWV survey
- do not live in Maryland
- Community Health Worker (CHW) Inclusion Criteria:
- certified Community Health Workers from Maryland
- completed accredited training by the Maryland Department of Health
- Primary Care Physician inclusion criteria:
- must have patients in Johns Hopkins University AWV
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mark G Luciano, PhD, FACS contact
United States2 sites
Johns Hopkins University and Hospital
Baltimore, Maryland, 21205
Hossein Zare, MS, PhD, 410-614-7246, hzare1@jhu.edu
Mark G Luciano, PhD, FACS, markluciano@jhu.edu
Johns Hopkins University
Baltimore, Maryland, 21205
About this study
Official title: Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus (NPH) in Maryland
The study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race, with a focus on the Black community. Interventions will include educational elements about NPH and three layers targeting patients, Primary Care Providers, and community health workers to enhance care access. Short-term outcomes will measure referrals to specialists, while long-term outcomes will assess healthcare utilization. The study aims to identify and reduce racial disparities in NPH care access, informing intervention strategies for NPH and other surgical areas.
Read the detailed description
This proposal responds to an established need for developing an evidence-based and community-informed approach to address health disparities in specialty surgical clinics where barriers to accessing care are multiplied along each level of the referral pathway. The study will focus on Normal Pressure Hydrocephalus (NPH) related care - a clinical syndrome characterized excess cerebrospinal fluid (CSF) in the brain resulting in symptoms of falls, dementia, and urinary incontinence, that is treated surgically by shunting to remove excess fluid from the brain. This disorder afflicts an estimated about 750,000 Americans, and prevalence increases with age. Limited information regarding racial and socioeconomic contributing factors associated with diagnosis and treatment is available.
Studies show NPH goes underdiagnosed in the USA. In the first part of the study the investigators will estimate NPH prevalence, the health equity gap in Baltimore and greater Maryland (MD), the health equity gap based on Zip Code as a marker of sociodemographic community status, and the health equity gap based on race, looking at the Black community, which comprises over 60% of the Baltimore and 30% in MD population. In the second part of the study, the investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care.
The success of these interventions will be evaluated by short-term outcomes such as referrals to specialists including neurologists and neurosurgeons every 6 months, and long-term outcomes such as healthcare utilization including screening for shunt surgery within 12 months. This study aims to identify racial disparities in access to NPH care and intervention outcomes will evaluate the effect of different interventions on reducing racial disparities and to help developing a referral system to address the needs of most vulnerable population and Zip Codes in Baltimore and greater MD. Using the results of this study will help to identify gaps, understand the best intervention, and develop intervention strategies not only for NPH but potentially other surgical areas.
- Conditions
- Normal Pressure Hydrocephalus, Hakim Syndrome
- Being tested
- patients will receive NPH education, primary care physicians (PCPs) will receive professional NPH education, A community health worker will assist PCP
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients will receive NPH educationOther
Patients will benefit from the Hydrocephalus Association's (HA) educational strategy for idiopathic normal pressure hydrocephalus (iNPH) emphasizes patient collaboration in the development of educational materials specifically for this condition. HA has a library of assets that include PowerPoint presentations, videos, and online and print educational materials. There will be also in-person outreach resulting recruitment, website (the study website and HA website), webform (with a symptom of gait, dementia, and bladder symptoms), YouTube videos. The investigators will also go to the communities like senior centers, health fair, and churches, then we will give a talk about iNPH. These resources will be carefully adjusted to suit low-income demographics, guided by feedback from Baltimore audiences and HA's iNPH volunteers.
primary care physicians (PCPs) will receive professional NPH educationOther
A comprehensive professional development program for PCPs and CHWs, featuring presentations, educational videos, webinars, and tools on iNPH diagnosis, treatment, and care management. Provider Continuing Medical Education (CME) credits will be offered for in-person lectures, aiming to equip PCPs with the skills needed to address iNPH in low-income settings effectively
A community health worker will assist PCPOther
A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.
| Study group | Role | What they receive |
|---|---|---|
| Patients and the patient's family | Experimental | All patients and the patient's family will receive NPH-related education. Receives: Other: patients will receive NPH education; Other: primary care physicians (PCPs) will receive professional NPH education; Other: A community health worker will assist PCP |
| PCPs Training | Experimental | Primary Care Provider (PCP) will receive NPH education. Receives: Other: primary care physicians (PCPs) will receive professional NPH education; Other: A community health worker will assist PCP |
| CHWs assist PCPs | Experimental | A community health worker (CHW) will assist PCP. Receives: Other: A community health worker will assist PCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of referrals
number of referrals for suspicion of NPH to neurologists or neurosurgeons
Measured: 6 months
number of screenings
number of screenings for shunt surgery
Measured: 12 months
number of screenings
number of screenings for shunt surgery
Measured: 24 months
Secondary outcomes (1)
number of NPH's consultations
number of patients who have received a consultation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Aug 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care.
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hossein Zare, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426004
- Sponsor's protocol ID
- IRB00028028
- Acronym
- NPH
- Status last verified
- May 2026
- First submitted
- 15 May 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and analytic plan will be freely available. In addition to analytical files, the Stata, Statistical Analysis System (SAS), R codes and programs and data dictionary will be available to researchers approved by one of the study's Principal Investigators to receive data. All papers must include an acknowledgment section that includes the funding source.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus (NPH) in Maryland
- ClinicalTrials.gov ID
- NCT06426004
- Acronym / sponsor ID
- NPH / IRB00028028
- Conditions
- Normal Pressure Hydrocephalus, Hakim Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Mar 2032 (estimated)
- First posted
- 23 May 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.
The study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race, with a focus on the Black community. Interventions will include educational elements about NPH and three layers targeting patients, Primary Care Providers, and community health workers to enhance care access. Short-term outcomes will measure referrals to specialists, while long-term outcomes will assess healthcare utilization. The study aims to identify and reduce racial disparities in NPH care access, informing intervention strategies for NPH and other surgical areas.
Detailed description
This proposal responds to an established need for developing an evidence-based and community-informed approach to address health disparities in specialty surgical clinics where barriers to accessing care are multiplied along each level of the referral pathway. The study will focus on Normal Pressure Hydrocephalus (NPH) related care - a clinical syndrome characterized excess cerebrospinal fluid (CSF) in the brain resulting in symptoms of falls, dementia, and urinary incontinence, that is treated surgically by shunting to remove excess fluid from the brain. This disorder afflicts an estimated about 750,000 Americans, and prevalence increases with age. Limited information regarding racial and socioeconomic contributing factors associated with diagnosis and treatment is available.
Studies show NPH goes underdiagnosed in the USA. In the first part of the study the investigators will estimate NPH prevalence, the health equity gap in Baltimore and greater Maryland (MD), the health equity gap based on Zip Code as a marker of sociodemographic community status, and the health equity gap based on race, looking at the Black community, which comprises over 60% of the Baltimore and 30% in MD population. In the second part of the study, the investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care.
The success of these interventions will be evaluated by short-term outcomes such as referrals to specialists including neurologists and neurosurgeons every 6 months, and long-term outcomes such as healthcare utilization including screening for shunt surgery within 12 months. This study aims to identify racial disparities in access to NPH care and intervention outcomes will evaluate the effect of different interventions on reducing racial disparities and to help developing a referral system to address the needs of most vulnerable population and Zip Codes in Baltimore and greater MD. Using the results of this study will help to identify gaps, understand the best intervention, and develop intervention strategies not only for NPH but potentially other surgical areas.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care.
| Arm | Type | Receives |
|---|---|---|
| Patients and the patient's family | Experimental | Other: patients will receive NPH education, Other: primary care physicians (PCPs) will receive professional NPH education, Other: A community health worker will assist PCPAll patients and the patient's family will receive NPH-related education. |
| PCPs Training | Experimental | Other: primary care physicians (PCPs) will receive professional NPH education, Other: A community health worker will assist PCPPrimary Care Provider (PCP) will receive NPH education. |
| CHWs assist PCPs | Experimental | Other: A community health worker will assist PCPA community health worker (CHW) will assist PCP. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- People over 65 years old who have completed the Annual Wellness Survey (AWV) survey
- have a clinical profile in the Hopkins Epic data sets
- live in Maryland
Key exclusion criteria (7 listed)
- People under 65 years old will be excluded if they have not completed the AWV survey
- do not live in Maryland
- certified Community Health Workers from Maryland
- completed accredited training by the Maryland Department of Health
- must have patients in Johns Hopkins University AWV
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 |
|---|---|---|
| patients will receive NPH educationPatients will benefit from the Hydrocephalus Association's (HA) educational strategy for idiopathic normal pressure hydrocephalus (iNPH) emphasizes patient collaboration in the development of educational materials specifically for this condition. HA has a library of assets that include PowerPoint presentations, videos, and online and print educational materials. There will be also in-person outreach resulting recruitment, website (the study website and HA website), webform (with a symptom of gait, dementia, and bladder symptoms), YouTube videos. The investigators will also go to the communities like senior centers, health fair, and churches, then we will give a talk about iNPH. These resources will be carefully adjusted to suit low-income demographics, guided by feedback from Baltimore audiences and HA's iNPH volunteers. | Other | Patients and the patient's family |
| primary care physicians (PCPs) will receive professional NPH educationA comprehensive professional development program for PCPs and CHWs, featuring presentations, educational videos, webinars, and tools on iNPH diagnosis, treatment, and care management. Provider Continuing Medical Education (CME) credits will be offered for in-person lectures, aiming to equip PCPs with the skills needed to address iNPH in low-income settings effectively | Other | PCPs Training, Patients and the patient's family |
| A community health worker will assist PCPA community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care. | Other | CHWs assist PCPs, PCPs Training, Patients and the patient's family |
Primary outcome
number of referrals
Time frame: 6 months
number of referrals for suspicion of NPH to neurologists or neurosurgeons
number of screenings
Time frame: 12 months
number of screenings for shunt surgery
number of screenings
Time frame: 24 months
number of screenings for shunt surgery
1 secondary outcome
number of NPH's consultations
Time frame: 24 months
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 7 May 2026.
- Individual participant dataSharing planned: Yes. The study protocol and analytic plan will be freely available. In addition to analytical files, the Stata, Statistical Analysis System (SAS), R codes and programs and data dictionary will be available to researchers approved by one of the study's Principal Investigators to receive data. All papers must include an acknowledgment section that includes the funding source.
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Recruiting
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Active, not recruiting
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Recruiting
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
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.
Mark G Luciano, PhD, FACS contact
Hossein Zare, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients will receive NPH education, primary care physicians (PCPs) will receive professional NPH education and A community health worker will assist PCP in people with Normal Pressure Hydrocephalus and Hakim Syndrome, run by Johns Hopkins Bloomberg School of Public Health at 2 sites 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Hossein Zare, MS, PhD (4106147246, hzare1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of referrals (time frame: 6 months). 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 7 May 2026.