Multiple SclerosisNCT03177785
Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
A study testing EverydayMatters in people with Multiple Sclerosis, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- EverydayMatters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2016to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years of age
- Diagnosis of multiple sclerosis
- regular access to the phone and internet
- willing to join a moderated group on MSConnection.org
Who cannot join
- under 45 years of age
- no diagnosis of multiple sclerosis
- no access to the phone or internet
- unwilling to join moderated group on MSConnection
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- EverydayMatters
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverydayMattersBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 6-weeks of telephone-delivered sessions, moderated by a trained clinician offering EverydayMatters MS. Receives: Behavioral: EverydayMatters |
| Control | No intervention | Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resilience using Connor Davidson Resilience Scale (brief)
10-item self-report measure of resilience.
Measured: 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
9-item self report measure
Measured: 6 weeks
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
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start4 Aug 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Ehde, University of Washington
- Investigators
- Dawn Ehde, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177785
- Sponsor's protocol ID
- 47142
- Status last verified
- Jun 2017
- First submitted
- 3 Apr 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 30024203
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT03177785
- Acronym / sponsor ID
- 47142
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: EverydayMatters6-weeks of telephone-delivered sessions, moderated by a trained clinician offering EverydayMatters MS. |
| Control | No intervention | –Wait-list control |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45 years of age
- Diagnosis of multiple sclerosis
- regular access to the phone and internet
- willing to join a moderated group on MSConnection.org
Key exclusion criteria (4 listed)
- under 45 years of age
- no diagnosis of multiple sclerosis
- no access to the phone or internet
- unwilling to join moderated group on MSConnection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverydayMatters | Behavioural | Intervention |
Primary outcome
Change in Resilience using Connor Davidson Resilience Scale (brief)
Time frame: 6 weeks
10-item self-report measure of resilience.
3 secondary outcomes
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
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles Short Form
Time frame: 6 weeks
Change in disease-management self-efficacy using the University of Washington Self-Efficacy Scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Derived from this study: PubMed 30024203Alschuler 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.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Ehde principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing EverydayMatters in people with Multiple Sclerosis, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resilience using Connor Davidson Resilience Scale (brief) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.