DepressionIQANNCT01837875
Intervention to Improve Quality of Life in African American Lupus Patients
A study testing Chronic Disease Self-Management Program (CDSMP), Mail-delivered arthritis kit and Support group in people with Depression and Systemic Lupus Erythematosus, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Systemic Lupus Erythematosus
- What is being tested?
- Chronic Disease Self-Management Program (CDSMP), Mail-delivered arthritis kit and Support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- formal diagnosis of lupus
- Black or African American
Who cannot join
- Younger than 18 years
- CNS/neuropsychiatric lupus and/or dementia
- participation in a chronic disease self management program in the last 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Partnerships to Eliminate Health Disparities, University of South Carolina
Columbia, South Carolina, 29210
About this study
Official title: Intervention to Improve Quality of Life for African-AmericaN Lupus Patients (IQAN)
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.
Read the detailed description
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.
- Conditions
- Depression, Systemic Lupus Erythematosus
- Being tested
- Chronic Disease Self-Management Program (CDSMP), Mail-delivered arthritis kit, Support group, Listserv
- Keywords
- Intervention, Quality of life, African American, Stress
- Medical subject headings
- Depression, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Self-Management Program (CDSMP)Behavioural
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.
Mail-delivered arthritis kitBehavioural
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.
Support groupBehavioural
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.
ListservBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Behavioral: Chronic Disease Self-Management Program (CDSMP); Behavioral: Mail-delivered arthritis kit; Behavioral: Support group; Behavioral: Listserv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: Two years
Secondary outcomes (1)
Disease Activity
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion30 Jun 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of South Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837875
- Sponsor's protocol ID
- IQAN
- Other IDs
- 1K01AR060026
- Acronym
- IQAN
- Status last verified
- Jun 2018
- First submitted
- 18 Apr 2013
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27485509
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Quality of Life for African-AmericaN Lupus Patients (IQAN)
- ClinicalTrials.gov ID
- NCT01837875
- Acronym / sponsor ID
- IQAN / IQAN
- Conditions
- Depression, Systemic Lupus Erythematosus
- Keywords
- Intervention, Quality of life, African American, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of South Carolina
- Study start
- Apr 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Mailed informational literature |
| Set Menu | Active comparator | Behavioral: Chronic Disease Self-Management Program (CDSMP)Intervention: Enrollment in a local Chronic Disease Self-Management program (CDSMP) and monthly follow up calls to gauge progress and comfort |
| Intervention | Experimental | Behavioral: Chronic Disease Self-Management Program (CDSMP), Behavioral: Mail-delivered arthritis kit, Behavioral: Support group, Behavioral: ListservIntervention: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- formal diagnosis of lupus
- Black or African American
Key exclusion criteria (3 listed)
- Younger than 18 years
- CNS/neuropsychiatric lupus and/or dementia
- participation in a chronic disease self management program in the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Disease Self-Management Program (CDSMP)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. | Behavioural | Intervention, Set Menu |
| Mail-delivered arthritis kitThe 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. | Behavioural | Intervention |
| Support groupInterested 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. | Behavioural | Intervention |
| ListservA 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. | Behavioural | Intervention |
Primary outcome
Quality of Life
Time frame: Two years
1 secondary outcome
Disease Activity
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Derived from this study: PubMed 27485509Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Disease Self-Management Program (CDSMP), Mail-delivered arthritis kit and Support group in people with Depression and Systemic Lupus Erythematosus, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.