NCT03335618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

October 19, 2017

Last Update Submit

August 18, 2020

Conditions

Multiple Sclerosis

Keywords

ActivityMood

Outcome Measures

Primary Outcomes (1)

  • Feasibility of an active symptom monitoring and intervention protocol

    To evaluate feasibility of the intervention, we will calculate how many patients remain in the study, levels of patient satisfaction with the monitoring and intervention, and we will analyze patient and provider feedback.

    12 weeks

Secondary Outcomes (3)

  • Improvement in ambulation symptoms in MS participants

    12 weeks

  • Improvement in mood symptoms in MS participants.

    12 weeks

  • Improvement in bladder symptoms in MS participants.

    12 weeks

Study Arms (2)

Active Coaching and Monitoring

EXPERIMENTAL
Other: Activity Monitoring and Symptom Coaching

Passive Monitoring

SHAM COMPARATOR
Other: Passive Activity Monitoring

Interventions

Activity Monitoring and Symptom CoachingOTHER

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

Active Coaching and Monitoring
Passive Activity MonitoringOTHER

Passive step tracking without check-ins

Passive Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (6)

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

    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.

    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.

    PMID: 25455299BACKGROUND

  • 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.

    PMID: 23240822BACKGROUND

  • 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.

    PMID: 26516627BACKGROUND

  • 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.

    PMID: 27896433BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Riley M Bove, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

November 8, 2017

Study Start

October 1, 2017

Primary Completion

August 1, 2019

Study Completion

March 23, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)