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

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Multiple Sclerosis; Depression; MS

Treatments: Behavioral: MS CATCH

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05865405

22-36620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Arm 1: 12 month MS CATCH tool intervention

Experimental group

Description:

Participants in arm 1 will receive 12 months of use of the MS CATCH tool. This will include in-visit interventions and monthly questionnaires.

Treatment:

Behavioral: MS CATCH

Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention

Other group

Description:

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".

Treatment:

Behavioral: MS CATCH