Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000417
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
1999-11-03
Brief Title:
Psychoeducational Approach to Improve Health in Lupus
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus SLE
Status:
COMPLETED
Status Verified Date:
2013-12
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:
We will study the relationships among patientpartner communication social support and self-efficacy a persons belief in the ability to manage his or her disease as they affect the health of people with systemic lupus erythematosus SLE or lupus over time We are assigning 150 people with lupus and their partners to either 1 receive counseling to improve self-efficacy partner support and patientpartner problem solving or 2 see an informational film about lupus We will follow study participants for 12 months to find out about their physical and mental health disease activity beliefs that they can take steps that help them feel better coping social support and couples communication
Detailed Description:
Studies have shown that patient self-efficacy in disease management and social support predict physical and mental health and disease activity in lupus We wished to study the relationships among patientpartner communication social support and self-efficacy as they influence patient health longitudinally We are randomizing 150 lupus patients and their partners to either 1 participate in a counseling intervention to improve self-efficacy partner support and patientpartner problem-solving in lupus management or 2 see an informational film about lupus control The counseling intervention includes an initial in-person session followed by five monthly telephone calls to monitor and reinforce problem-solving We will follow patients for 12 months for self-reported physical and mental health disease activity self-efficacy coping social support and couples communication
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P60AR036308 | NIH | None | httpsreporternihgovquickSearchP60AR036308 |