Back to resultsEngagement in CHildhood-Onset Systemic Lupus (ECHOS)
Primary Purpose
Lupus Erythematosus, Systemic, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Valera Smart Phone Application and Care Manager Dashboard
Sponsored by
About this trial
This is an interventional prevention trial for Lupus Erythematosus, Systemic focused on measuring Engagement in care, Mobile health
Eligibility Criteria
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).
Sites / Locations
- Montefiore Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valera Pilot Study
Arm Description
All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard
Outcomes
Primary Outcome Measures
Percentage of Participants who utilize the Valera Application (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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05693571
First Posted
December 5, 2022
Last Updated
October 13, 2023
Sponsor
Montefiore Medical Center
Collaborators
Childhood Arthritis and Rheumatology Research Alliance, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT05693571
Brief Title
Engagement in CHildhood-Onset Systemic Lupus
Acronym
ECHOS
Official Title
Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
Childhood Arthritis and Rheumatology Research Alliance, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic, Depression
Keywords
Engagement in care, Mobile health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Valera Pilot Study
Arm Type
Experimental
Arm Description
All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard
Intervention Type
Behavioral
Intervention Name(s)
Valera Smart Phone Application and Care Manager Dashboard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants who utilize the Valera Application (Feasibility - Application Utilization)
Description
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.
Time Frame
6 months
Title
Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Engagement in Care - Number of participants with one or more visits
Description
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.
Time Frame
6 months
Title
SLE disease activity - patient reported
Description
Patient reported cSLE disease activity as defined by the SLE Activity Questionnaire (SLAQ). The SLAQ is a binary assessment tool which asks a single Patient Global Assessment question about presence and severity of lupus activity; questions on 24 specific symptoms of disease activity; and a single Numerical Rating Scale (NRS) asking the patient to rate disease activity on a scale of 0 - 10 (0 = 'no activity' and 10 = 'most activity'). Likert responses with four response categories (no problem, mild, moderate, and severe) are used for the single Patient Global Assessment as well as the 24 specific symptom questions. A higher composite score indicates increased lupus disease activity.
Time Frame
12 weeks
Title
SLE disease activity - patient reported
Description
Patient reported cSLE disease activity as defined by the SLE Activity Questionnaire (SLAQ). The SLAQ is a binary assessment tool which asks a single Patient Global Assessment question about presence and severity of lupus activity; questions on 24 specific symptoms of disease activity; and a single Numerical Rating Scale (NRS) asking the patient to rate disease activity on a scale of 0 - 10 (0 = 'no activity' and 10 = 'most activity'). Likert responses with four response categories (no problem, mild, moderate, and severe) are used for the single Patient Global Assessment as well as the 24 specific symptom questions. A higher composite score indicates increased lupus disease activity.
Time Frame
6 months
Title
SLE disease activity - clinically assessed, 12 weeks
Description
Clinically assessed lupus disease activity defined by SLE disease activity index (SLEDAI 2K). SLEDAI-2K is a binary scoring system based on the presence of 24 descriptors in nine organ systems assessed over the preceding 30 days. Descriptors of SLEDAI-2K are documented as either present or absent. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores.
Time Frame
12 weeks
Title
SLE disease activity - clinically assessed, 6 months
Description
Clinically assessed lupus disease activity defined by SLE disease activity index (SLEDAI 2K). SLEDAI-2K is a binary scoring system based on the presence of 24 descriptors in nine organ systems assessed over the preceding 30 days. Descriptors of SLEDAI-2K are documented as either present or absent. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores.
Time Frame
6 months
Title
Depression symptom severity, 12 weeks
Description
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.
Time Frame
12 weeks
Title
Depression symptom severity, 6 months
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamar Rubinstein, MD, MS
Phone
718-696-2604
Email
trubinst@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Evin F Rothschild
Email
evin.rothschild@einsteinmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamar Rubinstein, MD, MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar B Rubinstein, MD, MS
Phone
718-696-2604
Email
trubinst@montefiore.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Engagement in CHildhood-Onset Systemic Lupus
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