Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT03149094
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The purpose of this study is to create a smartphone, tablet and web-based application to help people deal with stress. Stress often increases fatigue in people with HIV infection, so successfully dealing with stress could help reduce HIV-related fatigue. The study is being done at one site, the Medical University of South Carolina. Approximately 30 people will take part in this portion of the study.
Detailed Description:
For this study we will develop a fatigue symptom self-management cognitive behavioral stress management (CBSM) program that will be delivered via mHealth through smartphones and tablets (optimized for each). All CBSM content will be integrated into the application, but tailoring of information delivery will be derived through algorithm-driven feedback based on user input as they respond to integrated assessment and symptom monitoring questions. As a result, users of the CBSM-Self Management Intervention (CBSM-SMI) will receive personalized, relevant intervention content, when they need it, where they need it. This novel mode of CBSM delivery has not yet been provided via an mHealth format to HIV-infected individuals, despite its obvious advantages insofar as cost and reach are concerned.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1P20NR016575-01 | NIH | None | https://reporter.nih.gov/quic… | View |