A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis

Study Overview
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Brief Summary
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The researchers want to find out if an electronic application called MS CATCH can enhance patients' and doctors' experiences during and in between clinical visits. MS CATCH is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their Neurologist in their electronic medical record. The neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health.

Detailed Description
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MS-CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with Multiple Sclerosis) is a behaviorally informed, digital health, closed-loop-intervention that brings longitudinal mood reporting into the point of care. It consists of a simple tool used by the patient to improve mood reporting. This then triggers real-time alerts delivered to the clinician, who can access a comprehensive dashboard featuring risk factors and interventions to be considered, as well as resources local to the patient. This dashboard launches straight from the patient's electronic health record (EHR). MS-CATCH was designed using extensive human-centered design in all phases of development, and HIPAA compliant REDCap for electronic data capture. While the tool requires institutional approvals to launch within the UCSF EHR, the design elements could be readily repurposed using these technologies to support other institutions' requirements. Each individual care component and visualization was then developed and refined using extensive stakeholder engagement and an eye to the COM-B (Capability, Opportunity, and Motivation to change Behavior) principles of behavioral change, in order to promote behaviors likely to improve depression reporting, screening, comprehensive treatment and follow through.

Official Title
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Care Technology to Ascertain, Treat, and Engage the Community to Heal Depression in Patients With Multiple Sclerosis: Closing the Gaps in Depression Care for People With MS By Closing the Information Loop

Conditions
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Multiple Sclerosis, MS, Depression

Intervention / Treatment
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* Behavioral: MS CATCH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18 Ages 18 to 80 PHQ-9 score of 5-19 Any MS therapy, or no treatment California resident to enable clinical telemedicine visits if warranted during the study visit Exclusion Criteria: Cognitive dexterity or visual impairment (typically defined as corrected acuity less than 20/70) that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to adhere to the study protocol Inability to provide informed consent Psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder Substance abuse that in the treating neurologist's perspective could influence the patient's safety on study or adherence to study protocol Another co-morbid CNS diagnosis eg. TBI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Both arm 1 and arm 2 groups of participants will receive at least 6 months of MS CATCH tool intervention, with arm 1 receiving 12 months of intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: 12 month MS CATCH tool intervention<br>Participants in arm 1 will receive 12 months of use of the MS CATCH tool. This will include in-visit interventions and monthly questionnaires. | Behavioral: MS CATCH<br>* Participants will respond to a set of surveys every month to increase communication on mood with their clinician.<br>|
| Other: Arm 2: 6 month usual care, 6 month MS CATCH tool intervention<br>Participants in arm 2 will receive 6 months usual care followed by 6 months of MS CATCH tool intervention. These first 6 months will be used to assess the definition of usual care. | Behavioral: MS CATCH<br>* Participants will respond to a set of surveys every month to increase communication on mood with their clinician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients initially using the tool (adoption) | This will be measured by calculating the percentage patients who use the tool during the initial month of the study | 1st month of study | 
| Percentage of patients who continue to use the tool (Engagement) | The percentage patients who continued to use the patient-facing tool at least quarterly (used the tool at least once every 3 months) | 12 months | 
| Percentage of patient-clinician encounters who use the tool during the 12 month visit (Engagement) | The percentage of the clinician-patient dyads in Arm 1 who use the in-visit dashboard at the 12M clinical visit. | 12 months | 
| Percentage of patients who respond to mental health prompts (Adherence) | The percentage depression-reporting prompts responded to per participant on their patient-facing tool | 12 months | 
| Percentage of participants who respond to mental health prompts (Adherence) | The percentage participants responding to >75% depression prompts. | 12 months | 
| Change in clinician screening of depression: Arm 1 vs Arm 2 | Percent of visits where mood screening was documented by the clinician for arm 1 vs. percent of visits where mood screening was documented by the clinician for arm 2. This will be compared in the electronic health record for the baseline visits. | Baseline | 
| Change in clinician screening of depression: Arm 1 vs Arm 2 | Percent of visits where mood screening was documented by the clinician for arm 1 vs. percent of visits where mood screening was documented by the clinician for arm 2. This will be compared in the electronic health record for the 6 month visits. | 6 month | 
| Clinician comprehensive depression evaluation | The percentage of depression risk factors evaluated at each patient visit. | 12 months | 
| Preventative care recommendations | Percentage of visits in which applicable preventative care was recommended | 12 months | 
| Percentage of patient-clinician encounters that initially use the tool (adoption) | The percentage of patient-clinical dyads who use the tool during the 6 month clinical visit | 6 month visit | 
| Percentage patient follow-through on clinician recommended interventions: first 6 months | The percent of interventions recommended at each visit that were completed by the following 6 month visit. (completed interventions/total interventions recommended *100) | Baseline and 6 months | 
| Percentage patient follow-through on clinician recommended interventions: 6-12 months | The percent of interventions recommended at each visit that were completed by the following 6 month visit. (completed interventions/total interventions recommended *100) | 6 month and 12 months | 
| Points of patient follow-through on clinician recommended interventions: first 6 months | The completion of clinician recommended interventions that were completed by the following 6 month visit, tallied according to this scale: 0 = No interventions recommended, or no follow through by patient = 1 intervention recommended, and follow through on 1 intervention, or 2+ interventions recommended, and patient follow through on 1 intervention = 2+ interventions recommended, and patient follow through on 2+ interventions | Baseline and 6 months | 
| Points of patient follow-through on clinician recommended interventions: 6-12 months | The completion of clinician recommended interventions that were completed by the following 6 month visit, tallied according to this scale: 0 = No interventions recommended, or no follow through by patient = 1 intervention recommended, and follow through on 1 intervention, or 2+ interventions recommended, and patient follow through on 1 intervention = 2+ interventions recommended, and patient follow through on 2+ interventions | 6 month and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HADS-D (Hospital Anxiety and Depression Screener - Depression) | Changes in HADS-D over the first 6 months of the study. The HADS-D questionnaire ranges from 0-21, with a higher score indicating more impairment. | Baseline and 6 months | 
| The amount of participants that stay active in the study (trial retention) | The trial retention, or how many participants choose to remain in the study will be observed at the 3, 6, 9, and 12 month timepoints. Final reporting of these measures will be at the end of the 12 month period. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, Multiple Sclerosis, Depression, Depressed