Intervention to Improve Quality of Life in African American Lupus Patients

NCT01837875 | Completed DMC

• 2 other identifiers: IQAN1K01AR060026
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed project is to enhance the Principal Investigator's research ability to conduct behavioral interventions for people with lupus. This includes intervention design, implementation, data collection and data analysis. The Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN) Project is designed to examine whether a uniquely tailored intervention program can improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African American lupus patients. This study builds on three decades of work conducted in the field of arthritis self-management but differs in that the intervention mode, the disease (lupus), and the study population (African-Americans) are unstudied or understudied. The IQAN Project will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model as its theoretical framework. This program has three specific aims. The first aim seeks to design a three armed randomized, wait list controlled trial that employs a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction, allowing them to choose as many or few as they wish. The second aim is to assess the intervention, using the RE-AIM model framework. The third aim, to be achieved before the first aim, is to use previously collected data to characterize patient-centric barriers to care in African-American lupus patients, in order to identify trends in patient needs and desires, as well as correlates of non-response and non-compliance that can be used in the development and refinement of the intervention.

Conditions

Depression; Systemic Lupus Erythematosus

Keywords

Intervention; Quality of life; African American; Stress

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Two years

Secondary Outcomes (1)

• Disease Activity

  Two years

Other Outcomes (1)

• Stress

  Two years

Study Arms (3)

Control

NO INTERVENTION

Mailed informational literature

Set Menu

ACTIVE COMPARATOR

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

Behavioral: Chronic Disease Self-Management Program (CDSMP)

Intervention

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).

Behavioral: Chronic Disease Self-Management Program (CDSMP); Behavioral: Mail-delivered arthritis kit; Behavioral: Support group; Behavioral: Listserv

Interventions

Chronic Disease Self-Management Program (CDSMP) BEHAVIORAL

The Chronic Disease Self-Management Program (CDSMP) is a 2.5 hour workshop given weekly for six weeks. People with different chronic health problems attend together and support one another in making positive changes in their health. Workshops are facilitated by two trained leaders, one or both of whom are non-health professionals with a chronic disease themselves. It is the process in which the program is taught that makes it effective. Classes are highly participative, and mutual support builds the participants' confidence in their ability to manage their health and maintain active and fulfilling lives.

Intervention; Set Menu

Mail-delivered arthritis kit BEHAVIORAL

The Arthritis Self-Management Tool Kit contains 1) a "Self Test" to help participants determine how arthritis affects their lives and self-tailor the use of the Tool Kit, including items related to pain, fatigue, physical limitations, and health worries; 2) information sheets: Working with Your Doctor and the Health Care System; Exercise; Medications; Healthy Eating; Fatigue and Pain Management; Finding Community Resources; and Dealing with One's Emotions; 3) information sheets on key process components of the ASMP: Action Planning, Problem Solving, Deciding What to Try, and Individualizing an Exercise Program; 4) The Arthritis Helpbook; 5) audio relaxation and exercise compact discs (CDs); and 6) an audio CD of all material printed on the information sheets.

Intervention

Support group BEHAVIORAL

Interested participants will be referred to the "Lupus: Listening and Learning Group", a Charleston-based support group affiliated with the Lupus Foundation of America (LFA). One to two LFA-trained facilitators implement the group. The meeting format generally includes a specific discussion topic or an informative presentation such as by a medical or counseling professional, pharmacist, or lupus researcher. This program is followed by time within the group for further interaction and support among the attendees who wish to participate. The Lupus: Listening and Learning Group is open to all lupus patients, family members, friends and supporters, and there is no pre-registration or fee involved.

Intervention

Listserv BEHAVIORAL

A project listserv will be established to link all intervention participants to facilitate exchange of coping strategies, pose questions, and share preferred educational resources or any other information relative to their everyday and disease-specific experiences and/or participation in the project. Participants will be provided with a URL, from which they will be able to subscribe to the listserv. Once subscribed, they will be able to post and receive messages, managed by a listserv moderator, who will be responsible for distribution to listserv members as appropriate. Participants will have the option to unsubscribe at any time.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• formal diagnosis of lupus
• Black or African American

You may not qualify if:

• Younger than 18 years
• CNS/neuropsychiatric lupus and/or dementia
• participation in a chronic disease self management program in the last 12 months

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• University of South Carolina: collaborator

Study Sites (1)

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

Columbia, South Carolina, 29210, United States

Location

Related Publications (1)

• Williams EM, Lorig K, Glover S, Kamen D, Back S, Merchant A, Zhang J, Oates JC. Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN): study protocol for a randomized controlled trial of a unique a la carte intervention approach to self-management of lupus in African Americans. BMC Health Serv Res. 2016 Aug 2;16(a):339. doi: 10.1186/s12913-016-1580-6.

  PMID: 27485509 DERIVED

MeSH Terms

Conditions

Depression; Lupus Erythematosus, Systemic

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2013
• Primary Completion: June 30, 2016
• Study Completion: August 31, 2016
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

US (1)