Atlantic Lipid Lowering Treatment Optimization Program
Part of paid clinical trials in Clark, New Jersey.
- Sponsor
- Atlantic Health System
- Study ID
- NCT06439654
- Status
- Recruiting
Conditions
- Apolipoprotein B 100, Familial Defective
- Familial Hypercholesterolemia
- High Density Lipoprotein Deficiency
- Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia
- Low-Density-Lipoid-Type Hyperlipoproteinemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Not accepted
Interventions
- Supportive care — OTHERThe study model will utilize the accepted standard of care while implementing key enhancements to proactively reach high-risk patients as early as possible. Wrap around comprehensive care is defined as database screening, outreach, encouraging genetic testing for participants and their family members, and provide ongoing education, medical management (e.g., adherence to FDA-approved medications), routine laboratory testing, specialist referrals, Epic referrals to integrated care support such as pharmacy, nutrition, social work, and community health), and routine follow-up either in-person or using virtual visits. Consultations with pharmacists, nutritionists and genetic counselors or specialists to manage co-morbidities may be requested.
Study Details
Hypercholesterolemia is recognized as the major driver for cardiovascular morbidity and mortality. To help address this in our community, Atlantic Medical Group (AMG) formed a lipid workgroup chaired by Robert D. Fishberg, MD, and Jeffrey N. Feldman, MD. The overarching goal of the lipid workgroup is to enhance the treatment of lipid disorders in those patients with abnormal lipid levels by improving access to resources at the primary care practice level and specialty level. We aim to develop a model for primary and secondary prevention that integrates guidelines for treatment at the practice level. Our primary objective is to identify high-risk patients by utilizing the electronic health record and partnering with patients' primary care providers to provide comprehensive medical management.
Key Dates
- Start date
- Jul 1, 2024
- Status verified
- Jul 2025
- Primary completion
- May 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 250 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Other: LDL-CMost recent LDL-C result
Primary Outcome Measure
Proportion of patients with LDL-C maintenance<100 [ Time Frame: 6 months from enrollment in study ]
Central Contacts
- Robert D Fishberg, MD973-467-0005
- Jeffrey N Feldman, MD908-686-9330
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Atlantic Medical Group | Clark | New Jersey | 07066 | Robert D Fishberg, MD (PRINCIPAL_INVESTIGATOR) Jeffrey N Feldman, MD (SUB_INVESTIGATOR) Deatrah Dubose, NP (SUB_INVESTIGATOR) Matthew Proute, MD (SUB_INVESTIGATOR) Nosagie Ohonba, MD (SUB_INVESTIGATOR) Tiffany Haynes, MD (SUB_INVESTIGATOR) Anusha Ramasray, MD (SUB_INVESTIGATOR) |
| Atlantic Medical Group | Springfield | New Jersey | 07081 | Jeffrey N Feldman, MD (SUB_INVESTIGATOR) Deatrah Dubose, NP (SUB_INVESTIGATOR) Matthew Proute, MD (SUB_INVESTIGATOR) Nosagie Ohonba, MD (SUB_INVESTIGATOR) Tiffany Haynes, MD (SUB_INVESTIGATOR) Anusha Ramasray, MD (SUB_INVESTIGATOR) Robert D Fishberg, MD (PRINCIPAL_INVESTIGATOR) Anjali Kakwani, PharmD (SUB_INVESTIGATOR) Cassidy Maggio, PharmD (SUB_INVESTIGATOR) |
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