## Protocol Section
### Identification Module
**NCT ID:** NCT06426004

**Acronym:** NPH

**Brief Title:** Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland

**Official Title:** Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus (NPH) in Maryland

#### Organization Study ID Info
**ID:** IRB00028028
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins Bloomberg School of Public Health
### Status Module
#### Completion Date
**Date:** 2030-03-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-04-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins Bloomberg School of Public Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Normal Pressure Hydrocephalus

- Hakim Syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

**Intervention 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 Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 660

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: patients will receive NPH education

- Other: primary care physicians (PCPs) will receive professional NPH education

- Other: A community health worker will assist PCP

**Label:** Patients and the patient's family

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Primary Care Provider (PCP) will receive NPH education.

**Intervention Names:**

- Other: primary care physicians (PCPs) will receive professional NPH education

- Other: A community health worker will assist PCP

**Label:** PCPs Training

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** A community health worker (CHW) will assist PCP.

**Intervention Names:**

- Other: A community health worker will assist PCP

**Label:** CHWs assist PCPs

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients and the patient's family

**Description:** 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.

**Name:** patients will receive NPH education

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- PCPs Training

- Patients and the patient's family

**Description:** 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

**Name:** primary care physicians (PCPs) will receive professional NPH education

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- CHWs assist PCPs

- PCPs Training

- Patients and the patient's family

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

**Name:** A community health worker will assist PCP

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** referrals for physical therapy, occupational therapy, psychiatry, neurology - movement disorder specialist, neurology neuropathy specialist, orthopedic surgery, neurosurgery- spine specialist, neuropsychologist

**Measure:** number of referrals

**Time Frame:** 12 months and 24 months

#### Primary Outcomes

**Description:** number of referrals for suspicion of NPH to neurologists or neurosurgeons

**Measure:** number of referrals

**Time Frame:** 6 months

**Description:** number of screenings for shunt surgery

**Measure:** number of screenings

**Time Frame:** 12 months

**Description:** number of screenings for shunt surgery

**Measure:** number of screenings

**Time Frame:** 24 months

#### Secondary Outcomes

**Description:** number of patients who have received a consultation

**Measure:** number of NPH's consultations

**Time Frame:** 24 months

### Eligibility Module

**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

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hzare1@jhu.edu

**Name:** Hossein Zare, MS, PhD

**Phone:** 4106147246

**Role:** CONTACT

**Contact 2:**

**Email:** markluciano@jhu.edu

**Name:** Mark G Luciano, PhD, FACS

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Baltimore

**Contacts:**

***Contact 1:***

- **Email:** hzare1@jhu.edu

- **Name:** Hossein Zare, MS, PhD

- **Phone:** 410-614-7246

- **Role:** CONTACT

***Contact 2:***

- **Email:** markluciano@jhu.edu

- **Name:** Mark G Luciano, PhD, FACS

- **Role:** CONTACT

***Contact 3:***

- **Name:** Hossein Zare, MS, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Mark G Luciano, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Sevil Yasar, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 6:***

- **Name:** Darrell Gaskin, MS, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Taiwo Akindahunsi, MD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Michelle Spencer, MS

- **Role:** SUB_INVESTIGATOR

***Contact 9:***

- **Name:** Jiangxia Wang, MA, MS

- **Role:** SUB_INVESTIGATOR

***Contact 10:***

- **Name:** Amanda Garzon, MIA

- **Role:** SUB_INVESTIGATOR

***Contact 11:***

- **Name:** Roger Clark

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Johns Hopkins University and Hospital

**State:** Maryland

**Zip:** 21205

**Location 2:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins University

**State:** Maryland

**Zip:** 21205

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins Bloomberg School of Public Health

**Name:** Hossein Zare, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** 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.

**Info Types:**

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** The investigators will release the data 2 years after finishing up the study on April 2030.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M9907

- Name: Hydrocephalus

- Relevance: HIGH

- As Found: Hydrocephalus

- ID: M9908

- Name: Hydrocephalus, Normal Pressure

- Relevance: HIGH

- As Found: Normal Pressure Hydrocephalus

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006849

- Term: Hydrocephalus

- ID: D000006850

- Term: Hydrocephalus, Normal Pressure

### Misc Info Module

- Version Holder: 2024-05-31
