Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623994
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya BEACON
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya BEACON
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEACON
Brief Summary:
This cluster randomized trial aims to learn about the effectiveness of task-sharing supported by an epilepsy medical records system EMRS hereafter referred to as BEACON with patient-tracking data in improving treatment adherence and retention in care in people with epilepsy in western Kenya
Detailed Description:
Epilepsy is a serious neurological condition and a major cause of morbidity and mortality Globally epilepsy prevalence is highest in sub-Saharan Africa and Kenya has a high disease burden Delay in treatment initiation and non-adherence increase disease-related burden in terms of low quality of life high healthcare costs risk for seizure-related injuries and premature death
The BEACON intervention is grounded in existing evidence-based intervention Task-sharing an intervention advocated by the World Health Organization and the Institute of Medicine Researchers will compare patients receiving the BEACON intervention to those receiving usual care to see if there are any differences in treatment adherence and retention in care between the groups Researchers will test BEACONs ability to 1 improve care retention and treatment adherence and 2 reduce seizure severity and perceived stigma and improve quality of life QoL The cost-effectiveness of the intervention will also be assessed Data will be collected at baseline 12 and 18 months if warranted
This project will also build clinical and research capacity for epilepsy work in western Kenya
The BEACON intervention is grounded in existing evidence-based intervention Task-sharing an intervention advocated by the World Health Organization and the Institute of Medicine Researchers will compare patients receiving the BEACON intervention to those receiving usual care to see if there are any differences in treatment adherence and retention in care between the groups Researchers will test BEACONs ability to 1 improve care retention and treatment adherence and 2 reduce seizure severity and perceived stigma and improve quality of life QoL The cost-effectiveness of the intervention will also be assessed Data will be collected at baseline 12 and 18 months if warranted
This project will also build clinical and research capacity for epilepsy work in western Kenya
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None