Clinical trial NCT05865405: A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
MS
Depression
Keywords: MS
Multiple Sclerosis
Depression
Depressed
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mood Screening - Primary
timeFrame: 0-6 months, 0-12 months
measure: Mood Reporting - Secondary
timeFrame: 6 months, Baseline, 12 months
measure: Comprehensive Mood Evaluation - Secondary
timeFrame: 0-6 months, 0-12 months
measure: Treatment recommendations - Secondary
timeFrame: 0-6 months, 0-12 months
measure: Treatment recommendation follow-through - Secondary
timeFrame: 0-6 months, 0-12 months
measure: Adoption (uptake) - Primary
timeFrame: Initial month
measure: Adoption (uptake) - Secondary
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Mood scores - Primary
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Mood scores - Exploratory
timeFrame: 12 months
measure: Mood scores - Exploratory
timeFrame: 0-12 months, 0-6 months, 6-12 months
measure: Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory
timeFrame: 0-12 months, 0-6 months, 6-12 months
measure: Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory
timeFrame: 0-12 months, 0-6 months, 6-12 months
measure: Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory
timeFrame: 0-12 months, 0-6 months, 6-12 months
measure: Other self-reported outcome - Impact on Participation and Autonomy - Exploratory
timeFrame: 0-12 months, 0-6 months, 6-12 months
measure: Engagment (Sustained use) - Secondary
timeFrame: Every 3 months
measure: Engagement (Sustained use) - Secondary
timeFrame: 12 months
measure: Engagement (Sustained use) - Exploratory
timeFrame: Baseline, 6 month, 12 month
measure: Engagement (Sustained use) - Exploratoy
timeFrame: 12 month
measure: Engagement (Sustained use) - Exploratory
timeFrame: 12 month
measure: Adherence - Secondary
timeFrame: 12 months
Other outcomes:
measure: Trial retention - Exploratory
timeFrame: 12 months
measure: Self-Efficacy - Exploratory
timeFrame: Baseline-12 months
Locations:
city: San Francisco
country: United States
facility: Weill Institute for Neurosciences, University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Riley Bove, MD
role: PRINCIPAL_INVESTIGATOR
References: