Lupus Erythematosus, SystemicECHOSNCT05693571
Engagement in CHildhood-Onset Systemic Lupus
A study testing Valera Smart Phone Application and Care Manager Dashboard in people with Lupus Erythematosus, Systemic and Depression, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The goal of this observational (Aim 1) and pilot study (Aim 2) 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 the overall study attempts to answer are: 1. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Lupus Erythematosus, Systemic, Depression
- What is being tested?
- Valera Smart Phone Application and Care Manager Dashboard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants 15-25 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus
The goal of this observational (Aim 1) and pilot study (Aim 2) 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 the overall study attempts to answer are:
- Whether anhedonia (a core symptom of depression) predicts disengagement in care
- 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.
Read the detailed description
This registration is exclusive to the pilot study (Protocol Aim 2). The primary objective of Aim 2 is to assess the feasibility and acceptability of an adapted Valera application (app) in adolescents and young adults (AYA) with childhood-onset systemic lupus erythematosus (cSLE). As a part of Aim 1 (not a component of this registration), using a recognized patient-engaged methodology, "ADAPT-ITT"22, the study team will iteratively adapt and test the content and utilities of the app for cSLE AYA. During the 6-month pilot study which constitutes Aim 2, the investigator team will examine feasibility and acceptability through mixed-methods. Feasibility and acceptability will be assessed via app use and validated feasibility and acceptability of intervention measures.
- Conditions
- Lupus Erythematosus, Systemic, Depression
- Being tested
- Valera Smart Phone Application and Care Manager Dashboard
- Keywords
- Engagement in care, Mobile health
- Medical subject headings
- Lupus Erythematosus, Systemic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valera Smart Phone Application and Care Manager DashboardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Valera Pilot Study | Experimental | All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard Receives: Behavioral: Valera Smart Phone Application and Care Manager Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Application Utilization
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.
Measured: 6 months
Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)
Feasibility of the Intervention Measure (FIM) will be assessed by participant rating of application feasibility via 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 as follows: (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.
Measured: 6 months
Secondary outcomes (1)
Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)
Acceptability of the Intervention Measure (AIM) will be assessed by participant rating of application acceptability via 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. For purposes of this study a group mean score of ≥4 (representing "Agree" or "Completely agree") across the 4 items in ≥80% or participants will be an indicator of Acceptability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start5 Dec 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Childhood Arthritis and Rheumatology Research Alliance, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Tamar Rubinstein, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693571
- Sponsor's protocol ID
- 2022-14314
- Other IDs
- K23AR080803
- Acronym
- ECHOS
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data management and sharing (DMS) plans are no longer required for NIH Career Development (K) grant awards based on NIH Notice: NOT-OD-26-120, released 10/05/2026, and effective immediately.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus
- ClinicalTrials.gov ID
- NCT05693571
- Acronym / sponsor ID
- ECHOS / 2022-14314
- Conditions
- Lupus Erythematosus, Systemic, Depression
- Keywords
- Engagement in care, Mobile health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Childhood Arthritis and Rheumatology Research Alliance, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 Jan 2023 (actual)
- 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 this observational (Aim 1) and pilot study (Aim 2) 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 the overall study attempts to answer are:
- Whether anhedonia (a core symptom of depression) predicts disengagement in care
- 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.
Detailed description
This registration is exclusive to the pilot study (Protocol Aim 2). The primary objective of Aim 2 is to assess the feasibility and acceptability of an adapted Valera application (app) in adolescents and young adults (AYA) with childhood-onset systemic lupus erythematosus (cSLE). As a part of Aim 1 (not a component of this registration), using a recognized patient-engaged methodology, "ADAPT-ITT"22, the study team will iteratively adapt and test the content and utilities of the app for cSLE AYA. During the 6-month pilot study which constitutes Aim 2, the investigator team will examine feasibility and acceptability through mixed-methods. Feasibility and acceptability will be assessed via app use and validated feasibility and acceptability of intervention measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valera Pilot Study | Experimental | Behavioral: Valera Smart Phone Application and Care Manager DashboardAll participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants 15-25 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)
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| Valera Smart Phone Application and Care Manager DashboardValera 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. | Behavioural | Valera Pilot Study |
Primary outcome
Feasibility - Application Utilization
Time frame: 6 months
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.
Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)
Time frame: 6 months
Feasibility of the Intervention Measure (FIM) will be assessed by participant rating of application feasibility via 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 as follows: (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.
1 secondary outcome
Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Data management and sharing (DMS) plans are no longer required for NIH Career Development (K) grant awards based on NIH Notice: NOT-OD-26-120, released 10/05/2026, and effective immediately.
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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.
Tamar Rubinstein, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valera Smart Phone Application and Care Manager Dashboard in people with Lupus Erythematosus, Systemic and Depression, run by Montefiore Medical Center 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility - Application Utilization (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.