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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05693571
Other study ID # 2022-14314
Secondary ID K23AR080803
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date November 2026

Study information

Verified date February 2024
Source Montefiore Medical Center
Contact Tamar Rubinstein, MD, MS
Phone 718-696-2604
Email trubinst@montefiore.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this observational and pilot study is to better understand how depression symptoms may contribute to how well adolescent and young adults with lupus follow-up with their lupus clinical care. The main questions it aims to answer are: 1. Whether anhedonia (a core symptom of depression) predicts disengagement in care 2. Whether a patient-tailored mobile health application built to improve both engagement in care and depression symptoms will be feasible and acceptable to adolescents and young adults with lupus. Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 15 Years to 24 Years
Eligibility Inclusion Criteria: - Participants 15-24 years old meeting American College of Rheumatology (ACR) Revised SLE Classification Criteria and/or European League Against Rheumatism/ACR Classification Criteria and/or 2012 SLE International Collaborating Clinic Criteria and followed at the Children's Hospital at Montefiore. - Must be diagnosed with SLE before 19 years of age (based on Childhood-onset systemic lupus erythematosus (cSLE) definition) Exclusion Criteria: - Non-Spanish or non-English speaking - Participants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-up - Current psychotic disorders. However, attention-deficit/hyperactivity disorder, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorder, eating disorders, and substance abuse disorders are not uncommon among adolescents and young adults (AYA) and will be allowed. Suicidal ideations (SI) and self-injurious acts (cutting) are common in depression and will be allowed (defined as passive SI).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Valera Smart Phone Application and Care Manager Dashboard
Valera mobile health application will provide educational materials around mental health and Systemic Lupus Erythematosus (SLE) and the ability to connect to a SLE care team via a care manager.

Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (3)

Lead Sponsor Collaborator
Montefiore Medical Center Childhood Arthritis and Rheumatology Research Alliance, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Engagement in Care - Number of participants with one or more lupus visits Engagement in Care will be defined by the number of participants who have completed at least 1 clinical cSLE visit during the 6-month pilot window. 6 months
Other SLE disease activity - patient reported Patient reported lupus disease activity as defined by the SLE Activity Questionnaire (SLAQ). The SLAQ is an assessment tool which asks a single Patient Global Assessment question about presence and severity of lupus activity disease activity on a scale of 0 - 10 (0 = 'no activity' and 10 = 'most activity') and questions on 24 specific symptoms of disease activity through Likert responses with four response categories (no problem, mild, moderate, and severe). A higher composite score indicates increased lupus disease activity. 12 weeks
Other SLE disease activity - patient reported Patient reported lupus disease activity as defined by the SLE Activity Questionnaire (SLAQ). The SLAQ is an assessment tool which asks a single Patient Global Assessment question about presence and severity of lupus activity disease activity on a scale of 0 - 10 (0 = 'no activity' and 10 = 'most activity') and questions on 24 specific symptoms of disease activity through Likert responses with four response categories (no problem, mild, moderate, and severe). A higher composite score indicates increased lupus disease activity. 6 months
Other SLE disease activity - clinically assessed Clinically assessed lupus disease activity defined by SLE disease activity index (SLEDAI 2K). SLEDAI-2K is a scoring system based on the (binary) presence or absence of 24 descriptors in nine organ systems assessed over the preceding 30 days. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores (range 0-105). 12 weeks
Other SLE disease activity - clinically assessed Clinically assessed lupus disease activity defined by SLE disease activity index (SLEDAI 2K). SLEDAI-2K is a scoring system based on the (binary) presence or absence of 24 descriptors in nine organ systems assessed over the preceding 30 days. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores (range 0-105). 6 months
Other Depression symptom severity Patient reported depression symptoms severity defined by Beck Depression Inventory-II (BDI-II). This questionnaire consists of a 21-item self reporting inventory answered by the participant based on a 4-point scale of increased severity of depression symptoms over the period. The results are totaled and a higher composite score is used as an indicator of increased severity of depression symptoms. 12 weeks
Other Depression symptom severity Patient reported depression symptoms severity defined by Beck Depression Inventory-II (BDI-II). This questionnaire consists of a 21-item self reporting inventory answered by the participant based on a 4-point scale of increased severity of depression symptoms over the period. The results are totaled and a higher composite score is used as an indicator of increased severity of depression symptoms. 6 months
Primary Feasibility - application utilization (percentage of participants who utilize the Valera application) Feasibility of the Valera health application will determined by the percentage of participants who utilize the Valera platform. Participants with repeated (i.e., >2) log-ins to both the care management and educational platforms will be considered users. A successful target percentage of = 80% of enrolled participants logging into the care plan on the application and utilizing the messenger system at least twice during the 6-month pilot will be considered highly feasible. 6 months
Primary Feasibility of the Intervention Measure (Participant Rating of Application Feasibility) Feasibility of the Intervention Measure (FIM) will be assessed by administration of a 4-item questionnaire at the end of the pilot study. Responses to each of the 4 questions will be evaluated on a 5-point scale Response (1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). A higher aggregate score denotes a more favorable participant rating of feasibility of the application. 6 months
Secondary Acceptability of the Intervention Measure (Participant Rating of Application Acceptability) Acceptability of the Intervention Measure (AIM) will be assessed by administration of a 4-item questionnaire at the end of the pilot study. Responses to each of the 4 questions will be evaluated on a 5-point scale Response (1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). A higher aggregate score denotes a more favorable participant rating of the application. 6 months
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