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| ID | Type | Description | Link |
|---|---|---|---|
| K23AR084475 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.
Patients with juvenile systemic lupus erythematosus (JSLE) and juvenile dermatomyositis (JDM) are at higher risk of cardiovascular disease, with premature mortality. Adolescents and young adults with JSLE/JDM experience high rates of psychological stress which is associated with worse cardiovascular health (CVH) behaviors, including inadequate physical activity, diet quality, and sleep. However, evidence-based behavioral interventions for stress reduction remain inaccessible for many adolescents and young adults with JSLE/JDM. There is a critical need for stress reduction interventions that are effective, accessible, and tailored to JSLE/JDM-specific experiences. 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress', or TEAM-LEADS, is an online stress reduction and CVH behavior promotion intervention for adolescents and young adults with JSLE/JDM. TEAM-LEADS will be evaluated in a Phase I open-label, single-arm successive cohort pilot trial in adolescents and young adults with JSLE and JDM. Participants will complete the online intervention and assessments at baseline, post-intervention, and follow-up. The study will evaluate feasibility, acceptability, adherence, and preliminary efficacy for stress reduction and CVH behavior promotion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAM-LEADS intervention arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEAM-LEADS | Behavioral | TEAM-LEADS will be an online, self-administered intervention for stress reduction and cardiovascular health behavior promotion in adolescents and young adults with juvenile-onset systemic lupus erythematosus and dermatomyositis |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores | T-scores range from 37 to 81.8. Higher T-scores indicate greater psychological stress (i.e. worse outcome). | From T1 (baseline visit, day 0) to T3 (Day 84) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiovascular Health Behaviors Score | Cardiovascular Health Behaviors Score is a composite of individual measures of diet quality, physical activity, and sleep duration. Scores range 0 to 100. Higher scores indicate better outcomes (i.e., greater presence of cardiovascular health behaviors) with scores = 100 indicating ideal diet quality, physical activity, and sleep duration. | From T1 (baseline visit, day 0) to T3 (up to Day 168) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaveh Ardalan, MD, MS | Contact | 919-684-6575 | kaveh.ardalan@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kaveh Ardalan, MD, MS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34798945 | Background | Ardalan K, Lloyd-Jones DM, Schanberg LE. Cardiovascular Health in Pediatric Rheumatologic Diseases. Rheum Dis Clin North Am. 2022 Feb;48(1):157-181. doi: 10.1016/j.rdc.2021.09.006. Epub 2021 Oct 29. |
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Study protocols, data collection instruments, data dictionaries, and statistical analysis plans will be deposited in Vivli repository via Duke University's institutional license.
Data will be made available at time of publication or the end of the performance period (whichever comes first). At a minimum, Vivli will make data available for researchers for 10 years, unless they are contractually unable to do so.
Vivli provide metadata, persistent identifiers (e.g. NCT ID), study search functions, and long-term access. Vivli repository is available to Duke investigators via institutional license and datasets are available via standardized process in which requestors search Vivli platform for the study, request the IPD data package (with requests reviewed per contributor's publicly stated requirements), and then access data in Vivli's secure environment (or download with permission).
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| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| D008180 | Lupus Erythematosus, Systemic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009043 | Motor Activity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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