Education and Assistance for Normal Pressure Hydrocephalus

(NPH Trial)

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

660 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment NPH Training for Normal Pressure Hydrocephalus?

Research shows that education programs and reorganized care can improve outcomes for patients with cognitive issues, like those with delirium or dementia. This suggests that similar educational and supportive approaches, like NPH Training, might help patients with Normal Pressure Hydrocephalus. ^{1 2 3 4 5}

How does the treatment for normal pressure hydrocephalus in this trial differ from other treatments?

This treatment focuses on education and assistance, which is unique compared to traditional medical or surgical interventions like shunt systems. It aims to improve patient understanding and management of the condition, potentially enhancing the overall treatment experience and outcomes. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Hossein Zare, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bedside coaching to improve nurses' recognition of delirium. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A multifactorial intervention program reduces the duration of delirium, length of hospitalization, and mortality in delirious patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Multicomponent Model to Improve Hospital Care of Older Adults with Cognitive Impairment: A Propensity Score-Matched Analysis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Children's health promotion through caregiver preparation in pediatric brain injury settings: compensating for shortened hospital stays with a three-phase model of health education and annotated bibliography. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Global Neurocognitive and Frontal Functions Analysis and Precision Intrathecal Pressure Measurement to Settle the Diagnostic Dilemma of the Normal Pressure Hydrocephalus: A Preliminary Experience. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Establishment and Benefits of a Normal Pressure Hydrocephalus Support Group on Patient Education and Experience. [2020]

8. Austria pubmed.ncbi.nlm.nih.gov

What is the appropriate shunt system for normal pressure hydrocephalus? [2016]

9. United States pubmed.ncbi.nlm.nih.gov

The neurobiology of normal pressure hydrocephalus. [2005]

10. Germany pubmed.ncbi.nlm.nih.gov

Normal pressure hydrocephalus: a qualitative study on outcome. [2014]