Multiple SclerosisNCT02815878
Enhance Wellness for Individuals With Long-Term Physical Disabilities
A study testing Enhance Wellness in people with Multiple Sclerosis and Muscular Dystrophy, run by University of Washington at 1 site in United States.
Trial summary
This project is an adaptation trial, testing the efficacy of an evidence-based community wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in a sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury, post-polio syndrome and muscular dystrophy. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Muscular Dystrophy, Post-polio Syndrome
- What is being tested?
- Enhance Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2014to Nov 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Multiple Sclerosis, Muscular Dystrophy, Post-Polio Syndrome, or Spinal Cord Injury diagnosis (Group 1 and 3)
- Living in King County, Washington (Group 1 only)
- Ability to read and understand English
Who cannot join
- Active suicidal ideation
- Requires the use of a mechanical ventilator to breathe or speak
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project Enhance for Adults Aging With Long-Term Physical Disability
This project is an adaptation trial, testing the efficacy of an evidence-based community wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in a sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury, post-polio syndrome and muscular dystrophy.
Read the detailed description
This is a quasi-experimental project, comparing the effects of Enhance Wellness in a sample of adults aged 45 years or older and living with long-term physical disability, to two quasi-control groups: a sample of adults without long-term disability participating in Enhance Wellness, and a sample of adults with long-term disability not participating in Enhance Wellness. Outcomes are collected pre-intervention and post-intervention, approximately 6-months apart.
- Being tested
- Enhance Wellness
- Medical subject headings
- Multiple Sclerosis, Muscular Dystrophies, Postpoliomyelitis Syndrome, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhance WellnessBehavioural
A 6-month health promotion intervention which pairs participants with a wellness coach to identify and pursue a health-related goal of their choosing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Intervention with Disability | Experimental | Participants with a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older receive Enhance Wellness for 6 months and complete pre and post outcome assessments. Receives: Behavioral: Enhance Wellness |
| Group 2: Intervention without Disability | Active comparator | Participants without a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older receive Enhance Wellness for 6 months and complete pre and post outcome assessments. Receives: Behavioral: Enhance Wellness |
| Group 3: No intervention | No intervention | Participants with a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older complete pre and post outcome assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire: Level of reported self-efficacy as measured by the University of Washington Self-Efficacy Scale Questionnaire
This is a self-reported measure of perceived efficacy to manage conditions or symptoms related to a person's physical disability or condition. Greater scores represent greater self-efficacy.
Measured: 6-months
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form
Self-reported measure of pain interference. Greater score indicate greater pain interference.
Measured: 6-months
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form
Self-reported measure of depression. Greater scores indicated greater depressive symptoms.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start12 May 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Molton, University of Washington
- Investigators
- Ivan R Molton, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815878
- Sponsor's protocol ID
- 47035
- Status last verified
- Oct 2017
- First submitted
- 22 Jun 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Enhance for Adults Aging With Long-Term Physical Disability
- ClinicalTrials.gov ID
- NCT02815878
- Acronym / sponsor ID
- 47035
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 12 May 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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 project is an adaptation trial, testing the efficacy of an evidence-based community wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in a sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury, post-polio syndrome and muscular dystrophy.
Detailed description
This is a quasi-experimental project, comparing the effects of Enhance Wellness in a sample of adults aged 45 years or older and living with long-term physical disability, to two quasi-control groups: a sample of adults without long-term disability participating in Enhance Wellness, and a sample of adults with long-term disability not participating in Enhance Wellness. Outcomes are collected pre-intervention and post-intervention, approximately 6-months apart.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Intervention with Disability | Experimental | Behavioral: Enhance WellnessParticipants with a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older receive Enhance Wellness for 6 months and complete pre and post outcome assessments. |
| Group 2: Intervention without Disability | Active comparator | Behavioral: Enhance WellnessParticipants without a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older receive Enhance Wellness for 6 months and complete pre and post outcome assessments. |
| Group 3: No intervention | No intervention | –Participants with a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older complete pre and post outcome assessments. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple Sclerosis, Muscular Dystrophy, Post-Polio Syndrome, or Spinal Cord Injury diagnosis (Group 1 and 3)
- Living in King County, Washington (Group 1 only)
- Ability to read and understand English
Key exclusion criteria (2 listed)
- Active suicidal ideation
- Requires the use of a mechanical ventilator to breathe or speak
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 |
|---|---|---|
| Enhance WellnessA 6-month health promotion intervention which pairs participants with a wellness coach to identify and pursue a health-related goal of their choosing. | Behavioural | Group 1: Intervention with Disability, Group 2: Intervention without Disability |
Primary outcome
Questionnaire: Level of reported self-efficacy as measured by the University of Washington Self-Efficacy Scale Questionnaire
Time frame: 6-months
This is a self-reported measure of perceived efficacy to manage conditions or symptoms related to a person's physical disability or condition. Greater scores represent greater self-efficacy.
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form
Time frame: 6-months
Self-reported measure of pain interference. Greater score indicate greater pain interference.
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form
Time frame: 6-months
Self-reported measure of depression. Greater scores indicated greater depressive symptoms.
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 3 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Ivan R Molton, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhance Wellness in people with Multiple Sclerosis and Muscular Dystrophy, run by University of Washington at 1 site in United States.
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 3 inclusion and 2 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Questionnaire: Level of reported self-efficacy as measured by the University of Washington Self-Efficacy Scale Questionnaire (time frame: 6-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.