NCT03177785

Brief Summary

This study aims to test the efficacy of the EverydayMatters Multiple Sclerosis (MS) program for individuals age 45 or older living with multiple sclerosis. The program involves a 6-week telephone-delivered program to promote resilience and happiness for individuals living with MS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable multiple-sclerosis

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

August 4, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

April 3, 2017

Last Update Submit

June 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Resilience using Connor Davidson Resilience Scale (brief)

    10-item self-report measure of resilience.

    6 weeks

Secondary Outcomes (3)

  • Change in positive affect and well being using the Quality of Life in Neurological Disorders (NeuroQoL) Positive Affect and Well-Being Short Form

    6 weeks

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles Short Form

    6 weeks

  • Change in disease-management self-efficacy using the University of Washington Self-Efficacy Scale

    6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

6-weeks of telephone-delivered sessions, moderated by a trained clinician offering EverydayMatters MS.

Behavioral: EverydayMatters

Control

NO INTERVENTION

Wait-list control

Interventions

EverydayMattersBEHAVIORAL
Intervention

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Diagnosis of multiple sclerosis
  • regular access to the phone and internet
  • willing to join a moderated group on MSConnection.org

You may not qualify if:

  • under 45 years of age
  • no diagnosis of multiple sclerosis
  • no access to the phone or internet
  • unwilling to join moderated group on MSConnection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alschuler KN, Arewasikporn A, Nelson IK, Molton IR, Ehde DM. Promoting resilience in individuals aging with multiple sclerosis: Results from a pilot randomized controlled trial. Rehabil Psychol. 2018 Aug;63(3):338-348. doi: 10.1037/rep0000223. Epub 2018 Jul 19.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dawn Ehde

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Rehabilitation Medicine

Study Record Dates

First Submitted

April 3, 2017

First Posted

June 6, 2017

Study Start

August 4, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share