- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177785
Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
June 2, 2017 updated by: Dawn Ehde, University of Washington
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 45 years of age
- Diagnosis of multiple sclerosis
- regular access to the phone and internet
- willing to join a moderated group on MSConnection.org
Exclusion Criteria:
- under 45 years of age
- no diagnosis of multiple sclerosis
- no access to the phone or internet
- unwilling to join moderated group on MSConnection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
6-weeks of telephone-delivered sessions, moderated by a trained clinician offering EverydayMatters MS.
|
|
|
No Intervention: Control
Wait-list control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Resilience using Connor Davidson Resilience Scale (brief)
Time Frame: 6 weeks
|
10-item self-report measure of resilience.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in positive affect and well being using the Quality of Life in Neurological Disorders (NeuroQoL) Positive Affect and Well-Being Short Form
Time Frame: 6 weeks
|
9-item self report measure
|
6 weeks
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles Short Form
Time Frame: 6 weeks
|
4-item self-reported measure of satisfaction with participation in social roles and activities
|
6 weeks
|
|
Change in disease-management self-efficacy using the University of Washington Self-Efficacy Scale
Time Frame: 6 weeks
|
6-item self-report measure of self-efficacy for disability management
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dawn Ehde, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2016
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
April 3, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 6, 2017
Study Record Updates
Last Update Posted (Actual)
June 6, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 47142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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