Back to resultsTesting a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EverydayMatters
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
6-weeks of telephone-delivered sessions, moderated by a trained clinician offering EverydayMatters MS.
Wait-list control
Outcomes
Primary Outcome Measures
Change in Resilience using Connor Davidson Resilience Scale (brief)
10-item self-report measure of resilience.
Secondary Outcome Measures
Change in positive affect and well being using the Quality of Life in Neurological Disorders (NeuroQoL) Positive Affect and Well-Being Short Form
9-item self report measure
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles Short Form
4-item self-reported measure of satisfaction with participation in social roles and activities
Change in disease-management self-efficacy using the University of Washington Self-Efficacy Scale
6-item self-report measure of self-efficacy for disability management
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177785
Brief Title
Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
Official Title
Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 4, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
6-weeks of telephone-delivered sessions, moderated by a trained clinician offering EverydayMatters MS.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait-list control
Intervention Type
Behavioral
Intervention Name(s)
EverydayMatters
Primary Outcome Measure Information:
Title
Change in Resilience using Connor Davidson Resilience Scale (brief)
Description
10-item self-report measure of resilience.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in positive affect and well being using the Quality of Life in Neurological Disorders (NeuroQoL) Positive Affect and Well-Being Short Form
Description
9-item self report measure
Time Frame
6 weeks
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles Short Form
Description
4-item self-reported measure of satisfaction with participation in social roles and activities
Time Frame
6 weeks
Title
Change in disease-management self-efficacy using the University of Washington Self-Efficacy Scale
Description
6-item self-report measure of self-efficacy for disability management
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Ehde
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30024203
Citation
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.
Results Reference
derived
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Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
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