Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618638
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial for Shared Decision Making Model for Choosing Pharmacotherapy in ADPKD Patients
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:
SDM-ADOPT
Brief Summary:
The purpose of this study is to generate clinical evidence and assess the feasibility of a shared decision-making SDM model for the selection of Tolvaptan in patients with ADPKD
Detailed Description:
Autosomal dominant polycystic kidney disease ADPKD patients eligible to taking tolvaptan have to decide whether to take tolvaptan regarding critical factors such as water intake side effects and their personal values and preferences Our study aims to develop and validate a shared decision-making SDM model for ADPKD patients considering tolvaptan therapy
The SDM model we developed include a patient decision aid educational materials and self-monitoring tools all provided by a mobile application This model was built to deliver enough knowledge and considerations during a decision-making process which would be helpful for patients to reach a decision on tolvaptan
Through the multi-center hybrid randomized controlled trial the models effectiveness and feasibility will be evaluated Improvements in treatment outcomes patient satisfaction adherence and quality of life are anticipated This study can propose a structured patient-centered framework for therapeutic decision-making in ADPKD patients
The SDM model we developed include a patient decision aid educational materials and self-monitoring tools all provided by a mobile application This model was built to deliver enough knowledge and considerations during a decision-making process which would be helpful for patients to reach a decision on tolvaptan
Through the multi-center hybrid randomized controlled trial the models effectiveness and feasibility will be evaluated Improvements in treatment outcomes patient satisfaction adherence and quality of life are anticipated This study can propose a structured patient-centered framework for therapeutic decision-making in ADPKD patients
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