Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04198584
Status:
COMPLETED
Last Update Posted:
2022-10-24
First Post:
2019-12-09
Brief Title:
Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Pilot Feasibility Testing of a Small Randomized Controlled Trial to Evaluate a Telemedicine Stress Management and Lifestyle Group Intervention for Patients With Symptomatic Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2021-05
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:
VC-CBCS
Brief Summary:
A pilot feasibility study of a small randomized controlled trial RCT comparing a video-conferencing cognitive behavioral coping skills VC-CBCS group to standard of care SC for symptomatic patients previously diagnosed with chronic hepatitis C to evaluate feasibility patient satisfaction and differences in symptoms quality of life and liver markers
Detailed Description:
This is a pilot feasibility study of a small randomized controlled trial RCT to evaluate a cognitive behavioral coping skills CBCS delivered via videoconferencing referred to as the VC-CBCS compared to standard of care SC The study included a representative sample of 32 symptomatic patients who havehad chronic hepatitis C Patients n32 were randomized in a 13 ratio to 1 standard of care SC or 2 to participate in 14 two hour VC-CBCS sessions Four groups of patients were randomized and consisted of 7-9 patients each The groups were as follows
Group 1 7 patients with 5 randomized to VC-CBCS and 2 to SC
Group 2 9 patients with 7 randomized to VC-CBCS and 2 to SC
Groups 3 and 4 8 patients each with 6 randomized to VC-CBCS and 2 to SC each group
Each wave of VC-CBCS patients formed a group to join the Group Facilitator via a WebEx platform on a weekly basis using iPads from their homes The telehealth intervention provided group-based education skills and practices involving stress management coping with symptoms and support for healthy lifestyle changes The researchers examined 1 the feasibility of delivering a group intervention via telehealth technology remotely using iPads 2 participant satisfaction with the intervention and 3 whether differences are observed in several outcomes between the two conditions on quality of life physical and mental symptoms and liver markers Participants completed patient-reported outcome PRO surveys at four time points during the study with main outcomes being change from pre-intervention to post-intervention
Group 1 7 patients with 5 randomized to VC-CBCS and 2 to SC
Group 2 9 patients with 7 randomized to VC-CBCS and 2 to SC
Groups 3 and 4 8 patients each with 6 randomized to VC-CBCS and 2 to SC each group
Each wave of VC-CBCS patients formed a group to join the Group Facilitator via a WebEx platform on a weekly basis using iPads from their homes The telehealth intervention provided group-based education skills and practices involving stress management coping with symptoms and support for healthy lifestyle changes The researchers examined 1 the feasibility of delivering a group intervention via telehealth technology remotely using iPads 2 participant satisfaction with the intervention and 3 whether differences are observed in several outcomes between the two conditions on quality of life physical and mental symptoms and liver markers Participants completed patient-reported outcome PRO surveys at four time points during the study with main outcomes being change from pre-intervention to post-intervention
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21NR017908-01A1 | NIH | None | httpsreporternihgovquickSearch1R21NR017908-01A1 |