MS-CATCH: A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: 12 month MS CATCH tool intervention 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
Participants will respond to a set of surveys every month to increase communication on mood with their clinician.
|
| Other: Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention 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
Participants will respond to a set of surveys every month to increase communication on mood with their clinician.
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients initially using the tool (adoption) [1st month of study]
This will be measured by calculating the percentage patients who use the tool during the initial month of the study
- Percentage of patients who continue to use the tool (Engagement) [12 months]
The percentage patients who continued to use the patient-facing tool at least quarterly (used the tool at least once every 3 months)
- Percentage of patient-clinician encounters who use the tool during the 12 month visit (Engagement) [12 months]
The percentage of the clinician-patient dyads in Arm 1 who use the in-visit dashboard at the 12M clinical visit.
- Percentage of patients who respond to mental health prompts (Adherence) [12 months]
The percentage depression-reporting prompts responded to per participant on their patient-facing tool
- Percentage of participants who respond to mental health prompts (Adherence) [12 months]
The percentage participants responding to >75% depression prompts.
- Change in clinician screening of depression: Arm 1 vs Arm 2 [Baseline]
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.
- Change in clinician screening of depression: Arm 1 vs Arm 2 [6 month]
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.
- Clinician comprehensive depression evaluation [12 months]
The percentage of depression risk factors evaluated at each patient visit.
- Preventative care recommendations [12 months]
Percentage of visits in which applicable preventative care was recommended
- Percentage of patient-clinician encounters that initially use the tool (adoption) [6 month visit]
The percentage of patient-clinical dyads who use the tool during the 6 month clinical visit
- Percentage patient follow-through on clinician recommended interventions: first 6 months [Baseline and 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)
- Percentage patient follow-through on clinician recommended interventions: 6-12 months [6 month and 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)
- Points of patient follow-through on clinician recommended interventions: first 6 months [Baseline and 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
- Points of patient follow-through on clinician recommended interventions: 6-12 months [6 month and 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
Secondary Outcome Measures
- Change in HADS-D (Hospital Anxiety and Depression Screener - Depression) [Baseline and 6 months]
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.
- The amount of participants that stay active in the study (trial retention) [12 months]
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.
Other Outcome Measures
- Exploratory outcome: Patient Health Questionnaire-9 (PHQ-9) Scores [12 months]
Evaluate patient PHQ-9 scores. The PHQ-9 questionnaire ranges from 0-20, with a higher score indicating more severe depressive symptoms.
- Exploratory outcome: Mini International Neuropsychiatric Interview (MINI) Scores [12 months]
Evaluate patient MINI scores. The MINI assesses for 17 of the most common mental health disorders. The MINI is a "yes"/"no" screener, with certain answer choices leading to a most likely diagnosis. A score of 3 or more most likely correlates to depressive symptoms.
- Exploratory outcome: Changes in user self efficacy arm 1 vs arm 2 [12 months]
Changes in patient reported self efficacy at managing a chronic disease will be quantified between arms 1 and 2. This will be addressed in the final exit interview with participants after the study is completed. Our health literacy expert will generate a questionnaire based on major themes uncovered in Aim 1 along with consultation with psychiatry and inclusion experts.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18
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Ages 18 to 80
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PHQ-9 score of 5-19
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Any MS therapy, or no treatment
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California resident to enable clinical telemedicine visits if warranted during the study visit
Exclusion Criteria:
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Cognitive dexterity or visual impairment 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
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Inability to provide informed consent
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Psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Institute for Neurosciences, University of California, San Francisco | San Francisco | California | United States | 94158 |
Sponsors and Collaborators
- University of California, San Francisco
- United States Department of Defense
Investigators
- Principal Investigator: Riley Bove, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-36620