Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501144
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
Sponsor:
Kranus Health GmbH
Organization:
Kranus Health GmbH
Study Overview
Official Title:
Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-08
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:
RELOED
Brief Summary:
The goal of this observational study is to assess the long-term effectiveness of a digital health application for treating erectile dysfunction in men aged 18 and older The main questions it aims to answer are
Will participants maintain an improvement of their erectile function that means maintain an improvement of at least 3 points in the IIEF-5 score at 3 months post-therapy
How does the application affect overall health status and disease-related quality of life
Participants will
Complete validated questionnaires IIEF-5 PGI-I QOL-Med to track erectile function overall health status and quality of life at up to two follow-up points after using the app with a 3-month self-management program combining cardiovascular training pelvic floor exercises psychological support and educational content
Provide information on demographics risk factors and other relevant health characteristics for subgroup analysis
Will participants maintain an improvement of their erectile function that means maintain an improvement of at least 3 points in the IIEF-5 score at 3 months post-therapy
How does the application affect overall health status and disease-related quality of life
Participants will
Complete validated questionnaires IIEF-5 PGI-I QOL-Med to track erectile function overall health status and quality of life at up to two follow-up points after using the app with a 3-month self-management program combining cardiovascular training pelvic floor exercises psychological support and educational content
Provide information on demographics risk factors and other relevant health characteristics for subgroup analysis
Detailed Description:
The intervention that needs to be completed prior participation in this study involves a digital therapy program delivered via a smartphone or tablet application This program includes several components aimed at addressing different aspects for the treatment of erectile dysfunction
Pelvic Floor Exercises
Cardiovascular Exercises
Physiotherapeutic Exercises
Mental or sexual therapeutic Exercises
Educational Content
Overall the digital therapy program is designed to provide comprehensive support for men with erectile dysfuntion addressing both physical and psychological aspects of the condition to improve symptom severity quality of life and patient activation
Pelvic Floor Exercises
Cardiovascular Exercises
Physiotherapeutic Exercises
Mental or sexual therapeutic Exercises
Educational Content
Overall the digital therapy program is designed to provide comprehensive support for men with erectile dysfuntion addressing both physical and psychological aspects of the condition to improve symptom severity quality of life and patient activation
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