Pragmatic phase II clinical trial to improve depression care in a real-world diverse MS cohort from an academic MS centre in Northern California: MS CATCH study protocol

被引:2
|
作者
Henderson, Kyra [1 ]
Reihm, Jennifer [1 ]
Koshal, Kanishka [1 ]
Wijangco, Jaeleene [1 ]
Miller, Nicolette [1 ]
Sara, Narender [1 ]
Doyle, Marianne [1 ]
Mallory, Alicia [1 ]
Sheridan, Judith [2 ]
Guo, Chu-Yueh [1 ]
Oommen, Lauren [1 ]
Feinstein, Anthony [3 ]
Mangurian, Christina [4 ]
Lazar, Ann [5 ]
Bove, Riley [1 ]
机构
[1] Univ Calif San Francisco, UCSF Weill Inst Neurosci, Dept Neurol, San Francisco, CA 94143 USA
[2] Univ Calif San Francisco, San Francisco, CA USA
[3] Univ Toronto, Dept Psychiat, Toronto, ON, Canada
[4] Univ Calif San Francisco, Dept Psychiat, San Francisco, CA USA
[5] Univ Calif San Francisco, Dept Epidemiol & Biostat, San Francisco, CA USA
来源
BMJ OPEN | 2024年 / 14卷 / 02期
关键词
Quality of Life; Clinical Trial; Multiple sclerosis; Depression & mood disorders; eHealth; MULTIPLE-SCLEROSIS; HOSPITAL ANXIETY; VALIDATION; IMPACT; SCALE; PARTICIPATION; INSTRUMENT; CAPACITY; INDEX; AIM;
D O I
10.1136/bmjopen-2023-077432
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction Depression occurs in over 50% of individuals living with multiple sclerosis (MS) and can be treated using many modalities. Yet, it remains: under-reported by patients, under-ascertained by clinicians and under-treated. To enhance these three behaviours likely to promote evidence-based depression care, we engaged multiple stakeholders to iteratively design a first-in-kind digital health tool. The tool, MS CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with MS), closes the communication loop between patients and clinicians. Between clinical visits, the tool queries patients monthly about mood symptoms, supports patient self-management and alerts clinicians to worsening mood via their electronic health record in-basket. Clinicians can also access an MS CATCH dashboard displaying patients' mood scores over the course of their disease, and providing comprehensive management tools (contributing factors, antidepressant pathway, resources in patient's neighbourhood). The goal of the current trial is to evaluate the clinical effect and usability of MS CATCH in a real-world clinical setting. Methods and analysis MS CATCH is a single-site, phase II randomised, delayed start, trial enrolling 125 adults with MS and mild to moderately severe depression. Arm 1 will receive MS CATCH for 12 months, and arm 2 will receive usual care for 6 months, then MS CATCH for 6 months. Clinicians will be randomised to avoid practice effects. The effectiveness analysis is superiority intent-to-treat comparing MS CATCH to usual care over 6 months (primary outcome: evidence of screening and treatment; secondary outcome: Hospital Anxiety Depression Scale-Depression scores). The usability of the intervention will also be evaluated (primary outcome: adoption; secondary outcomes: adherence, engagement, satisfaction). Ethics and dissemination University of California, San Francisco Institutional Review Board (22-36620). The findings of the study are planned to be shared through conferences and publishments in a peer-reviewed journal. The deidentified dataset will be shared with qualified collaborators on request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analysed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.
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页数:10
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