Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955937
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-16
First Post:
2023-07-13
Brief Title:
ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
ImpleMEntation of a Digital-first Care deLiverY Model for Heart Failure in Uganda
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDLY Uganda
Brief Summary:
This is a stepped wedge cluster-randomized study that will implement a digital-first multi-component strategy for Heart Failure HF to improve HF self-care at 6 Regional Referral Hospital RRH outpatient departments in Uganda The investigators will evaluate both implementation and clinical outcomes using mixed methods First investigators will assess the implementation and clinical effectiveness of an enhanced standard-of-care clinical bundle and a digital health intervention to improve HF self-care in Uganda Aim 1 To do this the investigators will conduct a stepped-wedge cluster randomized trial that includes a brief control period followed by a clinical care service bundle for HF Core HF followed by the introduction of the digital health application Medly Uganda The co-primary outcomes will be the Self-Care of HF Index implementation and the composite of mortality and HF hospitalization clinical effectiveness
To ensure standardized basic HF care which will augment self-care investigators will train providers in an evidence-based HF clinical care service bundle Core HF including a care protocol treatment algorithm for HF self-care training for patients and providers and medication stock management prior to the introduction of the digital health intervention Medly Uganda Medly Uganda will utilize a patient-facing mobile health application designed to improve self-care among patients with HF Its principal components are 1 a patient-facing mobile application that processes patient-reported symptoms and generates algorithm-driven messages to guide self-care and symptom management and 2 a clinician-facing internet dashboard that monitors symptom reports and facilitates nurse-guided management recommendations and physician backup support The project supports an integrated digital interface at participating hospitals to monitor and intervene with patients using the mobile health application
To ensure standardized basic HF care which will augment self-care investigators will train providers in an evidence-based HF clinical care service bundle Core HF including a care protocol treatment algorithm for HF self-care training for patients and providers and medication stock management prior to the introduction of the digital health intervention Medly Uganda Medly Uganda will utilize a patient-facing mobile health application designed to improve self-care among patients with HF Its principal components are 1 a patient-facing mobile application that processes patient-reported symptoms and generates algorithm-driven messages to guide self-care and symptom management and 2 a clinician-facing internet dashboard that monitors symptom reports and facilitates nurse-guided management recommendations and physician backup support The project supports an integrated digital interface at participating hospitals to monitor and intervene with patients using the mobile health application
Detailed Description:
In parallel to the above the investigators will conduct a mixed methods process evaluation to inform iterative adjustments to the implementation processes ie a Learn- As-You-Go design by reviewing qualitative feedback and quantitative intervention data Aim 2 Then cost effectiveness and sustainability factors for Medly Uganda including an examination of cost cost-effectiveness and equity of Medly Uganda from a financial and societal perspective will be explored Aim 3
The focus of this registration will be Aim 1 and Aim 2
The focus of this registration will be Aim 1 and Aim 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL166585-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HL166585-01A1 |