Education and Assistance for Normal Pressure Hydrocephalus

(NPH Trial)

Not yet recruiting at 1 trial location

Overseen By Mark G Luciano, PhD, FACS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Under 65, Not Maryland resident

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding and improving care for Normal Pressure Hydrocephalus (NPH), a condition that affects fluid management in the brain, often leading to walking difficulties and memory problems. The study aims to determine the prevalence of NPH in Baltimore and Maryland and identify differences in care access, particularly within the Black community. Participants will receive education about NPH (referred to as NPH Training), and the study will track how this affects specialist referrals and healthcare use over time. Suitable candidates for this trial are Maryland residents over 65 who have completed a specific wellness survey. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance care and access for those with NPH.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational intervention is safe?

A previous study examined educational and supportive methods like the NPH Training. Research shows that online, doctor-led support groups can effectively educate and emotionally support patients with Normal Pressure Hydrocephalus (NPH). These findings suggest that this type of training is generally easy to manage and carries minimal risk. No reports of negative effects have emerged from these educational activities. Participants can feel confident about the safety of joining NPH Training, as it aims to increase awareness and understanding without involving physical treatments or medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for Normal Pressure Hydrocephalus (NPH) because it focuses on education and support rather than traditional surgical interventions like shunt surgery. Unlike standard treatments that solely target the physical symptoms, these interventions aim to empower patients, families, and healthcare providers through comprehensive NPH-related education. This approach could lead to better management of the condition by improving awareness and understanding among those affected and involved, potentially leading to earlier diagnosis and more effective overall care. By leveraging the expertise of community health workers to assist primary care providers, the trial also explores a collaborative healthcare model that could enhance patient support and outcomes.

What evidence suggests that this trial's educational interventions could be effective for improving NPH care access?

Research has shown that learning more about Normal Pressure Hydrocephalus (NPH) can improve patients' well-being. In past studies, patients who learned about NPH reported better understanding of their condition, easier coping, and increased emotional support. They also expressed high satisfaction with the education received. In this trial, participants will join different groups: one where patients and their families receive NPH-related education, another where community health workers assist primary care providers (PCPs), and a third where PCPs receive NPH education. Although this trial focuses on learning rather than a medical procedure, other studies have found that 60% to 70% of NPH patients improve with treatments like shunt surgery. Education can help patients recognize and access these effective treatments, potentially leading to better health. ^{3 4 5 6 7}

Who Is on the Research Team?

Hossein Zare, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for individuals in Maryland, particularly from the Black community, who may be affected by Normal Pressure Hydrocephalus (NPH). It aims to address health disparities and improve care access. Participants should be interested in learning about NPH or are healthcare providers looking to enhance their understanding of NPH management.

Inclusion Criteria

I am over 65 and have completed the Annual Wellness Survey.

Certified Community Health Workers from Maryland who have completed accredited training by the Maryland Department of Health

Primary Care Physicians who have patients in Johns Hopkins University AWV

Exclusion Criteria

People who do not live in Maryland

I am under 65 and haven't completed the AWV survey.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of three layers of interventions involving educational elements about NPH and evaluation of their benefits

6 months

Short-term Outcomes Evaluation

Evaluation of short-term outcomes such as referrals to specialists every 6 months

6 months

Long-term Outcomes Evaluation

Assessment of long-term outcomes including healthcare utilization and screening for shunt surgery within 12 months

12 months

Follow-up

Participants are monitored for the effectiveness of interventions in reducing racial disparities in NPH care access

6 months

What Are the Treatments Tested in This Trial?

Interventions

• NPH Training

Trial Overview The study tests educational interventions on NPH for patients and primary care providers. It includes training programs designed to increase awareness and improve referral rates to specialists. The goal is also to measure how these trainings affect long-term healthcare utilization among different racial groups.

How Is the Trial Designed?

Group I: Patients and the patient's family Experimental Treatment 3 Interventions

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

Group II: PCPs Training Experimental Treatment 2 Interventions

Primary Care Provider (PCP) will receive NPH education.

Group III: CHWs assist PCPs Experimental Treatment 1 Intervention

A community health worker (CHW) will assist PCP.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Published Research Related to This Trial

In a case study of a patient with normal pressure hydrocephalus (NPH), a programmable valve was implanted, but a lower opening pressure led to the development of a subdural hematoma despite symptom relief.

After evacuating the hematoma and increasing the valve pressure, the patient fully recovered, indicating that a higher pressure setting was necessary for optimal management of NPH symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the appropriate shunt system for normal pressure hydrocephalus? Chrissicopoulos, C., Mourgela, S., Kirgiannis, K., et al.[2016]

In a pilot study involving 47 participants aged 60 and over with dementia, person-centered care (PCC) significantly improved behavioral and neuropsychiatric symptoms and care quality compared to usual care after 4-5 days.

Sustained improvements in care quality were observed for patients with longer hospital stays, indicating that PCC can be beneficial for enhancing the overall care experience for individuals with dementia in acute hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. Chenoweth, L., Williams, A., Fry, M., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025000804

Utility and Efficacy of a Virtual Normal Pressure ... In this study, patients reported improved education, coping and communication skills, and emotional support. We also demonstrated high participant satisfaction ...

2. withpower.com withpower.com/trial/education-and-assistance-for-normal-pressure-hydrocephalus-37447

Education and Assistance for Normal Pressure ... This suggests that similar educational and supportive approaches, like NPH Training, might help patients with Normal Pressure Hydrocephalus.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06426004?term=University%20of%20Maryland,%20Baltimore&viewType=Table&rank=6

Addressing Health Disparities in Normal Pressure ... The study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9904195/

Placebo-Controlled Effectiveness of Idiopathic Normal ... Multiple prospective nonrandomized studies have shown 60% to 70% of patients with idiopathic normal pressure hydrocephalus (iNPH) improve with shunt surgery.

5. neurology.org neurology.org/doi/10.1212/WNL.86.16_supplement.P4.037

How Effective is a Multidisciplinary Approach in Normal ... Objective: To retrospectively review and determine the outcome of patients evaluated in a Multidisciplinary Normal Pressure Hydrocephalus ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36700738/

A Randomized Pilot Trial - PubMed - NIH This multicenter, randomized pilot study demonstrates the effectiveness, safety, and feasibility of a placebo-controlled trial in iNPH, ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2503109

A Randomized Trial of Shunting for Idiopathic Normal ... The PENS trial provides evidence that shunt surgery is effective for improving gait velocity at 3 months in patients with idiopathic normal- ...