Completed

IQANIntervention to Improve Quality of Life for African-AmericaN Lupus Patients (IQAN)

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What is being tested

Chronic Disease Self-Management Program (CDSMP)

+ Chronic Disease Self-Management Program (CDSMP)

+ Mail-delivered arthritis kit

Behavioral
Who is being recruted

Autoimmune Diseases+5

+ Behavior

+ Behavioral Symptoms

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorMedical University of South Carolina
Last updated: June 15, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

The intervention will be coordinated by an Intervention Coordinator, with assistance from local/MUSC Study Coordinators. A unique 'a-la-carte' self-management program will be offered to 50 African-American lupus patients participating in an ongoing SLE Clinic Database Project at MUSC. The Intervention Coordinator will work with each participant in the intervention arm to create an individualized intervention plan (IIP). Each IIP will include 1-4 options, including a mail-delivered arthritis kit, addition and access to a listserv, participation in a support group, and enrollment in local self-management program(s). Due to the nature of the IIP, the proposed intervention will inherently vary by participant. A 'set menu' control group of 50 lupus patients will be offered a standardized chronic disease self-management program only, and a control group of 50 lupus patients will receive usual care (UC), void of intervention components. Validated measures of stress, depression, and quality of life will be collected in all patients in each condition before and after intervention activities. To ensure intervention integrity, discrete components will follow written protocols and peer leaders will complete a standardized checklist for each session/encounter.

NCT01837875
Principal SponsorMedical University of South Carolina
Last updated: June 15, 2018
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

153 patients to be enrolled

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

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



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.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

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

Conditions

Pathology

Autoimmune DiseasesBehaviorBehavioral SymptomsConnective Tissue DiseasesImmune System DiseasesSkin and Connective Tissue DiseasesDepressionLupus Erythematosus, Systemic

Criteria

2 inclusion criteria required to participate
Black or African American

formal diagnosis of lupus

3 exclusion criteria prevent from participating
CNS/neuropsychiatric lupus and/or dementia

Younger than 18 years

participation in a chronic disease self management program in the last 12 months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Mailed informational literature

Group II

Active Comparator
Intervention: Enrollment in a local Chronic Disease Self-Management program (CDSMP) and monthly follow up calls to gauge progress and comfort

Group III

Experimental
Intervention: Each individualized intervention plan (IIP) will include 1-4 options, including a mail-delivered arthritis kit, addition and access to a listserv, participation in a support group, and enrollment in local self-management program(s).

Study Objectives

Primary Objectives

Secondary Objectives

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

Institute for Partnerships to Eliminate Health Disparities, University of South Carolina

Columbia, United StatesOpen Institute for Partnerships to Eliminate Health Disparities, University of South Carolina in Google Maps
CompletedOne Study Center