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Trial record 1 of 132 for:    Lupus AND (woman OR women OR female)
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Women Empowered to Live With Lupus Study (WELL)

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ClinicalTrials.gov Identifier: NCT02988661
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Cristina M Drenkard, Emory University

Brief Summary:
The purpose of this research is to examine whether the Chronic Disease Self-management Program (CDSMP) would improve health outcomes and reduce health care use in African American women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based self-management education program that has been shown to help people with chronic conditions to take control of their health problems. This study focuses on African American women with SLE because the CDSMP has not been widely studied in this population.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Behavioral: Chronic Disease Self-Management Program (CDSMP) Not Applicable

Detailed Description:

The CDSMP is an evidence-based, community-based, generic self-management program that consists of 6 weekly classes of two and a half hours each one, for six weeks. CDSMP classes are facilitated by certified peer leaders. Because the CDSMP is widely disseminated and available to the adult U.S. population through community centers, it may be a suitable and accessible option for African Americans with SLE, even though it is not specifically tailored to SLE or to African Americans. As the CDSMP has been primarily evaluated in predominantly white middle-class seniors with more common diseases (e.g. osteoarthritis, diabetes), the effectiveness of the CDSMP in helping African American women to self-manage SLE is unknown.

This study will examine the effectiveness of the CDSMP to improve patient-reported outcomes and reduce health care utilization in African American women with lupus. Using a two-group longitudinal cohort design with participants sampled from a parent population-based SLE cohort in Georgia, investigators will examine behaviors, health and healthcare outcomes, and the extent to which individual characteristics modify the effectiveness of the CDSMP.

The Georgians Organized Against Lupus (GOAL), a longitudinal cohort of patients with a validated diagnosis of SLE, will be used to enroll participants into the intervention. A random sample of African American women with SLE selected from the parent GOAL cohort will be recruited into the WELL (Women Empowered to Live with Lupus) cohort. WELL participants will attend the CDSMP classes in the community, along with people with other chronic illnesses. WELL participants will be asked to attend the CDSMP in the community and answer questionnaires at 4 select time periods before and after the program. Investigators will follow participant's progress for up to 18 months after they attend the CDSMP.

African American women from the GOAL cohort non-selected to be assigned to the intervention will comprise the usual care group. Participants will continue their longitudinal assessments as part of the GOAL cohort data collection efforts. Changes in outcomes for up to 18 months will be compared between WELL participants and the usual care group.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Women Empowered to Live With Lupus (WELL) Study
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Chronic Disease Self-management Program (CDSMP)
A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort will be used to recruit participants into the CDSMP. This group will be identified as the WELL Cohort.
Behavioral: Chronic Disease Self-Management Program (CDSMP)
The CDSMP consist of 6 weekly classes of two and a half hours each one, for six weeks. A group of 10-16 people with different chronic conditions attend the classes together. Classes are facilitated by two certified leaders, one or both of whom are non-health professionals with chronic diseases. The workshop covers topics such as: 1) how to deal with frustration, fatigue, pain and isolation, 2) exercise for maintaining and improving strength, flexibility, and endurance, 3) communicating effectively with family, friends, and health professionals, 4) nutrition, 5) decision making, 6) appropriate use of medications and how to evaluate new treatments. Participants receive a companion book, Living a Healthy Life with Chronic Conditions, and an audio relaxation CD, Relaxation for Mind and Body.
Other Name: Living Well with a Chronic Condition Workshop

No Intervention: Usual Care
African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who have not been selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.



Primary Outcome Measures :
  1. Change in Communication with Physicians assessed by the Stanford 3Q Scale [ Time Frame: Baseline, 18 Month Follow Up ]
    The Stanford 3Q Scale is a three question measure that assesses communication between patients and physicians. The participant is asked to rank their responses using a 5-point Likert scale. A higher score indicates better communication with physicians.

  2. Change in Self-efficacy for Managing Medications assessed by the PROMIS SF8a score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy SF8a for managing medications is an 8-item measure that assesses confidence in managing medication schedules of different complexity. Managing medication and other treatments in challenging situations such as when travelling, when running out of medication, and when adverse effects are encountered. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents not confident, and 5 represents very confident. A higher score indicates better self-efficacy.

  3. Change in Global Health assessed by the PROMIS Global Health score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor, and 5 represents excellent. A higher score indicates better overall health.

  4. Change in Physical Function assessed by the PROMIS SF10b score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function SF10b is a self-administered instrument that assesses self-reported capability rather than actual performance of physical activities. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents "unable to do" and 5 represents "without any difficulty". A higher score indicates better physical function capabilities.

  5. Change in Pain Interference assessed by the PROMIS SF8a score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference SF8a is a self-administered instrument that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents "not at all" and 5 represents "very much". A lower score indicates the least amount of pain interference.

  6. Change in Fatigue assessed by the PROMIS SF8a score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue SF8a is a self-administered instrument that assesses fatigue level within the past seven days. Participants are asked to respond to questions regarding fatigue frequency. Responses range from 1 to 5, where 1 represents "never" and five represents "always". A higher score indicates a higher fatigue level.

  7. Change in Sleep Disturbance assessed by the PROMIS SF8a score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance SF8a is a self-administered instrument to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. It assesses sleep disturbance over the past seven days. A higher score indicates more sleep disturbance.

  8. Change in Anxiety Level assessed by the PROMIS SF8a score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety SF8a is a self-administered instrument to assess emotional distress within the past seven days. Participants are asked to rate their anxiety level for various items ranked from 1 to 5, where 1 represents "never" and 5 represents "always". A higher score indicates high anxiety.

  9. Change in Ability to Participate in Social Roles and Activities assessed by the PROMIS SF8a score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities SF8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. A higher score indicates better perceived abilities.


Secondary Outcome Measures :
  1. Change in the Patient Activation Measure (PAM SF 10) score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Patient Activation Measure (PAM) is a tool to assess an individual's knowledge, skill, and confidence for managing one's health and healthcare. Individuals who measure high on this assessment typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so.The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum.

  2. Change in Self-Efficacy assessed by the PROMIS SF4a score [ Time Frame: Baseline, 18 Month Follow Up ]
    The PROMIS adult Self-Efficacy SF4a is a self-administered instrument to assess current level of confidence in managing chronic conditions, including confidence in managing daily activities, managing emotions, managing medications and treatments, managing social interactions and managing symptoms. A higher score indicates higher self-efficacy.

  3. Change in Angry Mood assessed by the PROMIS SF5 score [ Time Frame: Baseline, 18 Month Follow Up ]
    The PROMIS Anger SF5a is a self-administered instrument to measure angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. A higher score indicates more anger.

  4. Change in Perceived Stress Scale (PSS) Score [ Time Frame: Baseline, 18 Month Follow Up ]
    The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. Participants are asked to rank responses to item on a scale from 0 to 4; zero meaning never and four meaning very often. A higher score indicates higher perceived stress.

  5. Hospitalization Rate [ Time Frame: Up to 2 years ]
    The number of hospitalizations will be collected from administrative data for the pre- and post-intervention period (up to two years).

  6. Emergency Department Visit Rate [ Time Frame: Up to 2 years ]
    The number of emergency department visits will be collected from administrative data for the pre- and post-intervention period (up to two years).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently participating in the GOAL study

Exclusion Criteria:

  • Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years
  • Significant cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988661


Contacts
Contact: Charmayne M Dunlop-Thomas, MS, MPH 404-251-8898 cmdunlo@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Charmayne Dunlop-Thomas, MS, MPH    404-251-8898    cmdunlo@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Cristina M Drenkard, MD, PhD Emory University

Responsible Party: Cristina M Drenkard, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02988661     History of Changes
Other Study ID Numbers: IRB00003656
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristina M Drenkard, Emory University:
Autoimmunity
Immune System Disorders

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases