Completed

A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Counseling intervention

+ Informational film

ProcedureDevice
Who is being recruted

Treatment Adherence and Compliance+10

+ Adherence Interventions

+ Autoimmune Diseases

From 18 to 75 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1997
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Last updated: December 24, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1997

Actual date on which the first participant was enrolled.

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 patient/partner 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 patient/partner 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.

NCT00000417
Principal SponsorBrigham and Women's Hospital
Last updated: December 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceAdherence InterventionsAutoimmune DiseasesBehaviorConnective Tissue DiseasesImmune System DiseasesPatient Acceptance of Health CarePatient ComplianceHealth BehaviorSkin and Connective Tissue DiseasesMedication AdherenceHealth EducationLupus Erythematosus, Systemic

Criteria

1 inclusion criteria required to participate
Has partner willing to participate in study

3 exclusion criteria prevent from participating
Rheumatologist considers patient unable to participate, generally due to patient cognitive problems or severe illness

Unable to be reached by phone

Unable to read and write English questionnaires

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Brigham & Women's Hospital

Boston, United StatesOpen Brigham & Women's Hospital in Google Maps
CompletedOne Study Center