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

NCT06426004 | Not Yet Recruiting DMC

• 1 other identifier: IRB00028028
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 2

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.

Conditions

Normal Pressure Hydrocephalus; Hakim Syndrome

Outcome Measures

Primary Outcomes (3)

• number of referrals

  number of referrals for suspicion of NPH to neurologists or neurosurgeons

  6 months

• number of screenings

  number of screenings for shunt surgery

  12 months

• number of screenings

  number of screenings for shunt surgery

  24 months

Secondary Outcomes (1)

• number of NPH's consultations

  24 months

Other Outcomes (1)

• number of referrals

  12 months and 24 months

Study Arms (3)

Patients and the patient's family

EXPERIMENTAL

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

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.

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.

Other: A community health worker will assist PCP

Interventions

patients will receive NPH education 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.

Patients and the patient's family

primary care physicians (PCPs) will receive professional NPH education 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

PCPs Training; Patients and the patient's family

A community health worker will assist PCP 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; PCPs Training; Patients and the patient's family

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (2)

Johns Hopkins University and Hospital

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Interventions

Physicians, Primary Care

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Hossein Zare, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossein Zare, MS, PhD

CONTACT

4106147246; hzare1@jhu.edu

Mark G Luciano, PhD, FACS

CONTACT

markluciano@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 23, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2030
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: The investigators will release the data 2 years after finishing up the study on April 2030.

Locations

US (2)