Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583473
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
The Effectiveness of Integrated Interactive Digital Health Application and Telemonitoring in Patients with Heart Failure and Reduced Ejection Fraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Integrated Interactive Digital Health Application and Telemonitoring in Patients with Heart Failure and Reduced Ejection Fraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
Patient Source Patients discharged from the cardiology ward with heart failure
Intervention Group Prior to discharge patients will be provided with and instructed on how to use the Intelligent Interactive Personal Management System for Heart Failure as well as a Bluetooth-enabled blood pressure monitor and scale for remote data transmission
Control Group Patients will receive standard medical care
Assessment Method The Health-Related Quality of Life Questionnaire EQ-5D Kansas City Cardiomyopathy Questionnaire KCCQ-12 and Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being The 12-item Spiritual Well-Being Scale FACIT-Sp-12 will be completed before discharge and at 1 month 6 months and 12 months post-discharge The average time to complete the questionnaires is 10-15 minutes Additionally cardiovascular events and readmission rates will be tracked and analyzed over a 1-year period
Intervention Group Prior to discharge patients will be provided with and instructed on how to use the Intelligent Interactive Personal Management System for Heart Failure as well as a Bluetooth-enabled blood pressure monitor and scale for remote data transmission
Control Group Patients will receive standard medical care
Assessment Method The Health-Related Quality of Life Questionnaire EQ-5D Kansas City Cardiomyopathy Questionnaire KCCQ-12 and Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being The 12-item Spiritual Well-Being Scale FACIT-Sp-12 will be completed before discharge and at 1 month 6 months and 12 months post-discharge The average time to complete the questionnaires is 10-15 minutes Additionally cardiovascular events and readmission rates will be tracked and analyzed over a 1-year period
Detailed Description:
None
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