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

Depression Clinical Trial

— MS-CATCH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865405
• Other study ID #: 22-36620
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 15, 2025

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Riley Bove, MD
• Phone: 415.595.2795
• Email: riley.bove[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 15, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• MS
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• MS CATCH
Participants will respond to a set of surveys every month to increase communication on mood with their clinician.

Locations

Country	Name	City	State
United States	Weill Institute for Neurosciences, University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trial retention - Exploratory	Trial retention	12 months
Other	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
Primary	Mood Screening - Primary	Clinician screening of depression as documented in the electronic health record (EHR)	0-6 months, 0-12 months
Primary	Mood Reporting - Secondary	The percentage of patients who self-report mood at each clinical visit	6 months, Baseline, 12 months
Primary	Comprehensive Mood Evaluation - Secondary	The percentage of depression risk factors evaluated at each clinical visit	0-6 months, 0-12 months
Primary	Treatment recommendations - Secondary	The percentage of visits in which applicable care was recommended; number of preventative care recommendations	0-6 months, 0-12 months
Primary	Treatment recommendation follow-through - Secondary	The number/percent of preventative care recommendations followed through by next visit	0-6 months, 0-12 months
Primary	Adoption (uptake) - Primary	The percentage of patients using the tool during the first month of the study	Initial month
Primary	Adoption (uptake) - Secondary	The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit	Baseline, 6 months
Secondary	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
Secondary	Mood scores - Exploratory	Mini-International Neuropsychiatric Interview (MINI) assessment	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Engagment (Sustained use) - Secondary	The percentage of patients who continue to use the patient-facing tool at least quarterly	Every 3 months
Secondary	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
Secondary	Engagement (Sustained use) - Exploratory	Length of each session	Baseline, 6 month, 12 month
Secondary	Engagement (Sustained use) - Exploratoy	Qualitative feedback in exit interviews	12 month
Secondary	Engagement (Sustained use) - Exploratory	Net promoter score (NPS)	12 month
Secondary	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