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

N/AActive Not RecruitingNCT05865405

University of California, San Francisco100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mood Screening - Primary

Clinician screening of depression as documented in the electronic health record (EHR)

Time frame: 0-6 months, 0-12 months

Mood Reporting - Secondary

The percentage of patients who self-report mood at each clinical visit

Time frame: 6 months, Baseline, 12 months

Comprehensive Mood Evaluation - Secondary

The percentage of depression risk factors evaluated at each clinical visit

Time frame: 0-6 months, 0-12 months

Treatment recommendations - Secondary

The percentage of visits in which applicable care was recommended; number of preventative care recommendations

Time frame: 0-6 months, 0-12 months

Treatment recommendation follow-through - Secondary

The number/percent of preventative care recommendations followed through by next visit

Time frame: 0-6 months, 0-12 months

Adoption (uptake) - Primary

The percentage of patients using the tool during the first month of the study

Time frame: Initial month

Adoption (uptake) - Secondary

The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit

Time frame: Baseline, 6 months

Secondary Outcomes

Mood scores - Primary

Hospital Anxiety Depression Scale (HADS) will be measured at baseline, 3, 6, 9, and 12 months, scale: 0-21 range for depressive scale, and 0-21 range for anxiety scale, with higher score meaning more depressive or anxious symptoms

Time frame: Baseline, 3, 6, 9, and 12 months

Mood scores - Exploratory

Mini-International Neuropsychiatric Interview (MINI) assessment

Time frame: 12 months

Mood scores - Exploratory

Changes in Patient Health Questionnaire - 9 (PHQ-9), scale: 0-27, higher indicates more severe depressive symptoms