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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comprehensive Mood Evaluation - Secondary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician will be blinded to what arm participants are a part of.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: MS CATCH (Behavioral)
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".
干预措施: MS CATCH (Behavioral)
结局指标
主要结局
Comprehensive Mood Evaluation - Secondary
时间窗: 0-6 months, 0-12 months
The percentage of depression risk factors evaluated at each clinical visit
Mood Screening - Primary
时间窗: 0-6 months, 0-12 months
Clinician screening of depression as documented in the electronic health record (EHR)
Mood Reporting - Secondary
时间窗: 6 months, Baseline, 12 months
The percentage of patients who self-report mood at each clinical visit
Adoption (uptake) - Primary
时间窗: Initial month
The percentage of patients using the tool during the first month of the study
Treatment recommendations - Secondary
时间窗: 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
时间窗: 0-6 months, 0-12 months
The number/percent of preventative care recommendations followed through by next visit
Adoption (uptake) - Secondary
时间窗: Baseline, 6 months
The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit
次要结局
- Engagement (Sustained use) - Exploratory(12 month)
- Engagement (Sustained use) - Exploratoy(12 month)
- Mood scores - Primary(Baseline, 3, 6, 9, and 12 months)
- Mood scores - Exploratory(0-12 months, 0-6 months, 6-12 months)
- Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory(0-12 months, 0-6 months, 6-12 months)
- Other self-reported outcome - Impact on Participation and Autonomy - Exploratory(0-12 months, 0-6 months, 6-12 months)
- Engagment (Sustained use) - Secondary(Every 3 months)
- Engagement (Sustained use) - Secondary(12 months)
- Adherence - Secondary(12 months)
- Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory(0-12 months, 0-6 months, 6-12 months)
- Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory(0-12 months, 0-6 months, 6-12 months)