Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05729516
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2022-12-22
Brief Title:
The Hope App Study
Sponsor:
See Yourself Health LLC
Organization:
See Yourself Health LLC
Study Overview
Official Title:
The Hope App An Immersive Telehealth Solution for Older Adults With Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This research study will test how a computer program called the Hope App teaches diabetes care skills for older adults with diabetes The study will compare those who receive diabetes education 10 educational modules and monthly health coaching through the research program with those who receive care as usual
Detailed Description:
The Hope App offers a simple high-impact engaging and immersive telehealth experience with the potential to become a ubiquitous diabetes management tool to transform diabetes patients into high performing drivers of their own care
The research team aims to scale the platform develop features that are important to aging adults and run a clinical trial to validate the Hope Apps health benefits
Specific Aim 1 Develop the Hope Apps state-of-the-art immersive patient engagement experience with automated onboarding social networking and gamified DSMES features to support long-term patient retention In doing so usability testing will be performed to ensure patient-facing features on the platform and patient-facing content and curriculum materials are functioning and well received by participants
Specific Aim 2 Develop the Hope Apps predictive analytic capabilities for population health management
Specific Aim 3 Conduct a clinical validation trial of the Hope App intervention on six-month clinical outcomes Hemoglobin A1c patient reported outcomes diabetes distress and engagement outcomes patient retention adherence to self-care behaviors
The research team intends to deliver a scalable Hope App platform with a usable patient engagement portal designed for older adults and achieve decreases in blood glucose levels HbA1c and depressive burden and sustained patient engagement
The research team aims to scale the platform develop features that are important to aging adults and run a clinical trial to validate the Hope Apps health benefits
Specific Aim 1 Develop the Hope Apps state-of-the-art immersive patient engagement experience with automated onboarding social networking and gamified DSMES features to support long-term patient retention In doing so usability testing will be performed to ensure patient-facing features on the platform and patient-facing content and curriculum materials are functioning and well received by participants
Specific Aim 2 Develop the Hope Apps predictive analytic capabilities for population health management
Specific Aim 3 Conduct a clinical validation trial of the Hope App intervention on six-month clinical outcomes Hemoglobin A1c patient reported outcomes diabetes distress and engagement outcomes patient retention adherence to self-care behaviors
The research team intends to deliver a scalable Hope App platform with a usable patient engagement portal designed for older adults and achieve decreases in blood glucose levels HbA1c and depressive burden and sustained patient engagement
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