A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis (MS-CATCH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Multiple Sclerosis; MS
• Intervention / Treatment: Behavioral: MS CATCH

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riley Bove, MD; Phone Number: 415.595.2795; Email: riley.bove@ucsf.edu
• Study Contact Backup: Name: Kyra Henderson, BA; Phone Number: 415.353.8053; Email: kyra.henderson@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • Weill Institute for Neurosciences, University of California, San Francisco
      • Principal Investigator: Riley Bove, MD
      • Contact: Kyra Henderson; Phone Number: 415-353-8053; Email: kyra.henderson@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood Screening - Primary	Clinician screening of depression as documented in the electronic health record (EHR)	0-6 months, 0-12 months
Mood Reporting - Secondary	The percentage of patients who self-report mood at each clinical visit	6 months, Baseline, 12 months
Comprehensive Mood Evaluation - Secondary	The percentage of depression risk factors evaluated at each clinical visit	0-6 months, 0-12 months
Treatment recommendations - Secondary	The percentage of visits in which applicable care was recommended; number of preventative care recommendations	0-6 months, 0-12 months
Treatment recommendation follow-through - Secondary	The number/percent of preventative care recommendations followed through by next visit	0-6 months, 0-12 months
Adoption (uptake) - Primary	The percentage of patients using the tool during the first month of the study	Initial month
Adoption (uptake) - Secondary	The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood scores - Exploratory	Mini-International Neuropsychiatric Interview (MINI) assessment	12 months
Engagment (Sustained use) - Secondary	The percentage of patients who continue to use the patient-facing tool at least quarterly	Every 3 months
Engagement (Sustained use) - Secondary	The percentage of patient-clinician dyads in Arm 1 (early start) who continued to use the tool at the 12 month visit	12 months
Engagement (Sustained use) - Exploratory	Length of each session	Baseline, 6 month, 12 month
Engagement (Sustained use) - Exploratoy	Qualitative feedback in exit interviews	12 month
Engagement (Sustained use) - Exploratory	Net promoter score (NPS)	12 month
Adherence - Secondary	The percentage of depression-reporting prompts responded to per participant on their patient-facing tool; the percentage participants responding to >75% depression prompts	12 months
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	Baseline, 3, 6, 9, and 12 months
Mood scores - Exploratory	Changes in Patient Health Questionnaire - 9 (PHQ-9), scale: 0-27, higher indicates more severe depressive symptoms	0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory	Evaluating possible contributors to mood: fatigue (MFIS), scale: 0-84, higher score indicates more impact	0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory	Evaluating possible contributors to mood: sleep (PSQI), scale: 0-21, higher scores indicates worse sleep quality	0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory	Evaluating possible contributors to mood: engagement (Ox-PAQ), scale: 0-100, higher score indicates more problems with activity and participation	0-12 months, 0-6 months, 6-12 months
Other self-reported outcome - Impact on Participation and Autonomy - Exploratory	Evaluating possible contributors to mood: participation (IPA), scale: 0-128, with higher score indicating more impact on a person's autonomy and participation	0-12 months, 0-6 months, 6-12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial retention - Exploratory	Trial retention	12 months
Self-Efficacy - Exploratory	Changes in patient reported self efficacy at managing a chronic disease, reported using the "Self-efficacy for Managing a Chronic Disease 6-item Scale" (Lorig) Questionnaire.	Baseline-12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Riley Bove, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Multiple Sclerosis; MS; Depressed
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Mood Disorders; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Depression; Depressive Disorder; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 22-36620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The deidentified dataset will be shared with qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analyzed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.
• IPD Sharing Time Frame: 6 months post trial
• IPD Sharing Access Criteria: Qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No