Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland

NCT ID: NCT06426004

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2030-03-30

Brief 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. 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.

Conditions

Normal Pressure Hydrocephalus; Hakim Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients and the patient's family

All patients and the patient's family will receive NPH-related education.

Group Type: EXPERIMENTAL

patients will receive NPH education

Intervention Type: OTHER

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 education

Intervention Type: OTHER

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 PCP

Intervention Type: OTHER

A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.

PCPs Training

Primary Care Provider (PCP) will receive NPH education.

Group Type: EXPERIMENTAL

primary care physicians (PCPs) will receive professional NPH education

Intervention Type: OTHER

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 PCP

Intervention Type: OTHER

A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.

CHWs assist PCPs

A community health worker (CHW) will assist PCP.

Group Type: EXPERIMENTAL

A community health worker will assist PCP

Intervention Type: OTHER

A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.

Interventions

patients will receive NPH education

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.

Intervention Type: OTHER

primary care physicians (PCPs) will receive professional NPH education

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

Intervention Type: OTHER

A community health worker will assist PCP

A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• certified Community Health Workers from Maryland
• completed accredited training by the Maryland Department of Health

• must have patients in Johns Hopkins University AWV

Exclusion Criteria

• People under 65 years old will be excluded if they have not completed the AWV survey
• do not live in Maryland

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hossein Zare, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins University and Hospital

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Hossein Zare, MS, PhD

Role: CONTACT

hzare1@jhu.edu

4106147246

Mark G Luciano, PhD, FACS

Role: CONTACT

markluciano@jhu.edu

Facility Contacts

Hossein Zare, MS, PhD

Role: primary

hzare1@jhu.edu

410-614-7246

Mark G Luciano, PhD, FACS

Role: backup

markluciano@jhu.edu

Other Identifiers

IRB00028028

Identifier Type: -

Identifier Source: org_study_id