A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis
- Conditions
- MSDepressionMultiple Sclerosis
- Interventions
- Behavioral: MS CATCH
- Registration Number
- NCT05865405
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1: 12 month MS CATCH tool intervention MS CATCH Participants in arm 1 will receive 12 months of use of the MS CATCH tool. This will include in-visit interventions and monthly questionnaires. Arm 2: 6 month "usual care", 6 month MS CATCH tool intervention MS CATCH 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".
- Primary Outcome Measures
Name Time Method Mood Screening - Primary 0-6 months, 0-12 months Clinician screening of depression as documented in the electronic health record (EHR)
Comprehensive Mood Evaluation - Secondary 0-6 months, 0-12 months The percentage of depression risk factors evaluated at each clinical visit
Mood Reporting - Secondary 6 months, Baseline, 12 months The percentage of patients who self-report mood at each clinical visit
Adoption (uptake) - Primary Initial month The percentage of patients using the tool during the first month of the study
Treatment recommendations - Secondary 0-6 months, 0-12 months The percentage of visits in which applicable care was recommended; number of preventative care recommendations
Treatment recommendation follow-through - Secondary 0-6 months, 0-12 months The number/percent of preventative care recommendations followed through by next visit
Adoption (uptake) - Secondary Baseline, 6 months The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit
- Secondary Outcome Measures
Name Time Method Engagement (Sustained use) - Exploratory 12 month Net promoter score (NPS)
Engagement (Sustained use) - Exploratoy 12 month Qualitative feedback in exit interviews
Mood scores - Primary Baseline, 3, 6, 9, and 12 months 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
Mood scores - Exploratory 0-12 months, 0-6 months, 6-12 months Changes in Patient Health Questionnaire - 9 (PHQ-9), scale: 0-27, higher indicates more severe depressive symptoms
Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory 0-12 months, 0-6 months, 6-12 months Evaluating possible contributors to mood: fatigue (MFIS), scale: 0-84, higher score indicates more impact
Other self-reported outcome - Impact on Participation and Autonomy - Exploratory 0-12 months, 0-6 months, 6-12 months Evaluating possible contributors to mood: participation (IPA), scale: 0-128, with higher score indicating more impact on a person's autonomy and participation
Engagment (Sustained use) - Secondary Every 3 months The percentage of patients who continue to use the patient-facing tool at least quarterly
Engagement (Sustained use) - Secondary 12 months The percentage of patient-clinician dyads in Arm 1 (early start) who continued to use the tool at the 12 month visit
Adherence - Secondary 12 months The percentage of depression-reporting prompts responded to per participant on their patient-facing tool; the percentage participants responding to \>75% depression prompts
Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory 0-12 months, 0-6 months, 6-12 months Evaluating possible contributors to mood: sleep (PSQI), scale: 0-21, higher scores indicates worse sleep quality
Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory 0-12 months, 0-6 months, 6-12 months Evaluating possible contributors to mood: engagement (Ox-PAQ), scale: 0-100, higher score indicates more problems with activity and participation
Trial Locations
- Locations (1)
Weill Institute for Neurosciences, University of California, San Francisco
🇺🇸San Francisco, California, United States