Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544343
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy in Patients With Rheumatologic Diseases Comparison With Standard Management
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TEMPLATE
Brief Summary:
Systemic autoimmune and chronic inflammatory diseases are a group of chronic illnesses whose treatment is usually very prolonged often lifelong and is essential to keep the disease under control thus reducing the risk of complications and allowing the best possible quality of life for patients
The drugs used for treating these diseases are mostly immunosuppressants which reduce the activity of the immune system whose alteration is responsible for the disease Although all available drugs are effective for treating these diseases for reasons largely unknown each drug is effective only in a percentage of patients As a result it is often necessary to try several different treatments before identifying an effective one for the individual patient
The therapeutic effects are often slow and it is therefore necessary to take a treatment for weeks or months before its effectiveness can be determined The initial period is also when side effects most often appear The aim of this study is to evaluate whether the addition of remote monitoring visits and other patient support services to traditional periodic medical visits in the first months after the introduction of a new treatment leads to an improvement in adherence response and quality of life for the patient
The drugs used for treating these diseases are mostly immunosuppressants which reduce the activity of the immune system whose alteration is responsible for the disease Although all available drugs are effective for treating these diseases for reasons largely unknown each drug is effective only in a percentage of patients As a result it is often necessary to try several different treatments before identifying an effective one for the individual patient
The therapeutic effects are often slow and it is therefore necessary to take a treatment for weeks or months before its effectiveness can be determined The initial period is also when side effects most often appear The aim of this study is to evaluate whether the addition of remote monitoring visits and other patient support services to traditional periodic medical visits in the first months after the introduction of a new treatment leads to an improvement in adherence response and quality of life for the patient
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