Coaching and Activity Tracking in Multiple Sclerosis - A Pilot Study

NCT ID: NCT03335618

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-03-23

Brief Summary

The purpose of this 12-week, exploratory pilot clinical trial is to continuously and remotely assess a triad of bothersome multiple sclerosis (MS) symptoms (BAM: bladder, ambulation, mood) and test the benefit of proactively treating these symptoms according to an evidence-based, multi-disciplinary, personalized protocol.

Detailed Description

MS is a chronic, debilitating disease of the central nervous system affecting approximately 2 million people worldwide and more than 400,000 individuals in the US. MS is the most common cause of non-traumatic neurological disability in young adults. Symptoms typically first afflict individuals during the prime of their professional and reproductive lives, between the ages of 20 and 40. Many affected individuals are unemployed, physically disabled, and at high risk for social isolation. While disease-modifying therapies (DMTs) can significantly reduce accumulation of disability in MS, patients still experience symptoms across a range of functional domains. Symptoms can include problems with bladder, walking, and mood (depression and anxiety). Often, these symptoms are only partially evaluated during routine MS clinic visits, and the long interval between clinic visits can result in them not being optimally managed.

The goal of the current study is to pilot a system of proactively monitoring a combination of symptoms (bladder, ambulation and mood) using an activity monitor and a smartphone.

Adult patients with MS who are experiencing symptoms in at least 2 of the 3 domains (bladder, ambulation, mood) will be enrolled. Visits will be at baseline (can be same day as routine visit to the MS clinic), and 3 months. Short surveys (<3 minutes to complete) will occur weekly, and longer surveys will occur at baseline, 6 weeks and 3 months. FitBit activity monitors will be worn for the entire 3 months.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Coaching and Monitoring

Group Type: EXPERIMENTAL

Activity Monitoring and Symptom Coaching

Intervention Type: OTHER

Triggered check-ins by study personnel to keep participants on track to meet fitness goals

Passive Monitoring

Group Type: SHAM_COMPARATOR

Passive Activity Monitoring

Intervention Type: OTHER

Passive step tracking without check-ins

Interventions

Activity Monitoring and Symptom Coaching

Triggered check-ins by study personnel to keep participants on track to meet fitness goals

Intervention Type: OTHER

Passive Activity Monitoring

Passive step tracking without check-ins

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Any individual above the age of 18 with a confirmed diagnosis of MS
• Access to a smartphone
• Access to Wi-Fi at home
• Able to walk (including with a cane or walker)
• Willing to fill out surveys at multiple time points

Exclusion Criteria

• Clinician's assessment of cognitive, dexterity, or visual impairment limiting ability to use a smartphone and subsequent technologies required by the study
• Inability to walk

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riley M Bove, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

Bove R, Garcha P, Bevan C, et al. Towards a Tele-MSDS: an iterative method to assess the MS patient remotely. ECTRIMS. London 2016.

Reference Type: BACKGROUND

Ritvo PG F, J. S., Miller, D. M., Andrews, H., Paty, D. W., LaRocca, N.G. . Multiple Sclerosis Quality of Life Inventory: A User's Manual. New York: National Multiple Sclerosis Society, 1997.

Reference Type: BACKGROUND

Schwartz CE, Ayandeh A, Motl RW. Investigating the minimal important difference in ambulation in multiple sclerosis: a disconnect between performance-based and patient-reported outcomes? J Neurol Sci. 2014 Dec 15;347(1-2):268-74. doi: 10.1016/j.jns.2014.10.021. Epub 2014 Oct 18.

Reference Type: BACKGROUND

PMID: 25455299 (View on PubMed)

Motl RW, Pilutti L, Sandroff BM, Dlugonski D, Sosnoff JJ, Pula JH. Accelerometry as a measure of walking behavior in multiple sclerosis. Acta Neurol Scand. 2013 Jun;127(6):384-90. doi: 10.1111/ane.12036. Epub 2012 Dec 13.

Reference Type: BACKGROUND

PMID: 23240822 (View on PubMed)

Bove R, White CC, Giovannoni G, Glanz B, Golubchikov V, Hujol J, Jennings C, Langdon D, Lee M, Legedza A, Paskavitz J, Prasad S, Richert J, Robbins A, Roberts S, Weiner H, Ramachandran R, Botfield M, De Jager PL. Evaluating more naturalistic outcome measures: A 1-year smartphone study in multiple sclerosis. Neurol Neuroimmunol Neuroinflamm. 2015 Oct 15;2(6):e162. doi: 10.1212/NXI.0000000000000162. eCollection 2015 Dec.

Reference Type: BACKGROUND

PMID: 26516627 (View on PubMed)

Block VJ, Lizee A, Crabtree-Hartman E, Bevan CJ, Graves JS, Bove R, Green AJ, Nourbakhsh B, Tremblay M, Gourraud PA, Ng MY, Pletcher MJ, Olgin JE, Marcus GM, Allen DD, Cree BA, Gelfand JM. Continuous daily assessment of multiple sclerosis disability using remote step count monitoring. J Neurol. 2017 Feb;264(2):316-326. doi: 10.1007/s00415-016-8334-6. Epub 2016 Nov 28.

Reference Type: BACKGROUND

PMID: 27896433 (View on PubMed)

Other Identifiers

16-20505

Identifier Type: -

Identifier Source: org_study_id