Skip to navigation Skip to content
Menu

Navigation

National Multiple Sclerosis Society

Sign In
In Your Area
DonateDonate
v
  • What Is MS?

    • Definition of MS
    • What Causes MS?
    • Who Gets MS?
    • Multiple Sclerosis FAQs
    • Types of MS
    • Related Conditions
  • Symptoms & Diagnosis

    • MS Symptoms
    • Diagnosing MS
    • Magnetic Resonance Imaging (MRI)
    • Cerebrospinal Fluid (CSF)
    • Possible MS
    • Clinically Isolated Syndrome (CIS)
    • Newly Diagnosed
    • Other Conditions to Rule Out
    • For Clinicians
  • Treating MS

    • Comprehensive Care
    • Find Doctors & Resources
    • Medications
    • Managing Relapses
    • Rehabilitation
    • Complementary & Alternative Medicines
    • For Clinicians
  • Resources & Support

    • Library & Education Programs
    • Find Support
    • Advanced Care Needs
    • Resources for Specific Populations
    • Find Programs & Services in Your Area
    • Calendar of Programs and Events
    • Find Doctors & Resources
  • Living Well with MS

    • Diet, Exercise & Healthy Behaviors
    • Emotional Well-Being
    • Spiritual Well-Being
    • Cognitive Health
    • Work, Home & Leisure
    • Relationships
  • Research

    • Participate in Research Studies
    • Research News & Progress
    • Research We Fund
    • For Researchers
  • Get Involved

    • Fundraising Events
    • Volunteer
    • Advocate for Change
    • Raise Awareness
    • Join the Community
    • Stay Informed
    • Corporate Support
    • Personal Stories
  • d What Is MS?
    • d Definition of MS
      • Myelin
      • Immune-Mediated Disease
    • d What Causes MS?
      • Viruses
      • Clusters
    • d Who Gets MS?
      • Pediatric MS
      • African Americans
      • Hispanics & Latinos
    • d Multiple Sclerosis FAQs
    • d Types of MS
      • Clinically Isolated Syndrome (CIS)
      • Relapsing-remitting MS (RRMS)
      • Secondary progressive MS (SPMS)
      • Primary progressive MS (PPMS)
    • d Related Conditions
      • Acute Disseminated Encephalomyelitis (ADEM)
      • Balo’s Disease
      • HTLV-I Associated Myelopathy (HAM)
      • Neuromyelitis Optica (NMO)
      • Schilder's Disease
      • Transverse Myelitis
  • d Symptoms & Diagnosis
    • d Diagnosing MS
    • d Magnetic Resonance Imaging (MRI)
    • d Cerebrospinal Fluid (CSF)
    • d Possible MS
    • d Clinically Isolated Syndrome (CIS)
    • d Newly Diagnosed
    • d Other Conditions to Rule Out
      • Lyme Disease
      • Lupus
      • Neuromyelitis Optica
      • Acute Disseminated Encephalomyelitis (ADEM)
    • d For Clinicians
  • d Treating MS
    • d Comprehensive Care
      • Developing a Healthcare Team
      • Make the Most of Your Healthcare Provider Visits
      • Advance Medical Directives
    • d Find Doctors & Resources
    • d Medications
      • Adherence
      • Patient Assistance Programs
      • Meds Used Off Label
      • Make Medications Accessible
      • Generic and Biosimilar - Medications
    • d Managing Relapses
      • Plasmapheresis
    • d Rehabilitation
      • Functional Electrical Stimulation (FES)
    • d Complementary & Alternative Medicines
      • Chiropractic Therapy
      • Marijuana
      • Massage and Bodywork
      • Acupuncture
      • Low-Dose Naltrexone
    • d For Clinicians
  • d Resources & Support
    • d Library & Education Programs
      • Webinar Series
      • Momentum Magazine
      • Educational Videos
      • Knowledge Is Power
      • Pathways to a Cure
      • Live Fully, Live Well
      • Everyday Matters
      • Free From Falls
      • Relationship Matters
      • Resilience: Addressing the Challenges of MS
      • Webcasts
      • DVDs
      • Books
      • For Kids: Keep S'myelin
      • Información en Español
      • Brochures
    • d Find Support
      • Ask an MS Navigator
      • Community at MSconnection.org
      • Join a Local Support Group
      • Peer Connections: One-on-One
      • Edward M. Dowd Personal Advocate Program
    • d Advanced Care Needs
      • Pressure Sores
      • Osteoporosis
      • Seeking Services: Questions to Ask
    • d Resources for Specific Populations
      • Pediatric MS Support
      • Veterans with Multiple Sclerosis
    • d Find Programs & Services in Your Area
    • d Calendar of Programs and Events
    • d Find Doctors & Resources
  • d Living Well with MS
    • d Diet, Exercise & Healthy Behaviors
      • Diet & Nutrition
      • Exercise
      • Heat & Temperature Sensitivity
      • Sleep
      • Vaccinations
      • Women's Health
      • Unhealthy Habits
      • Managing MS and Another Condition
      • Aging with MS
      • Anesthesia and Surgery
      • Managing Your MS
    • d Emotional Well-Being
      • Mood Changes
    • d Spiritual Well-Being
      • Building Spirituality into Your Life
    • d Cognitive Health
    • d Work, Home & Leisure
      • Employment
      • Insurance & Financial Information
      • Staying Mobile
      • Reclaiming Control
      • Accessibility
      • Technology
      • Recreation
      • Travel
      • Emergencies & Disasters
    • d Relationships
      • Disclosure
      • Family Matters
      • Parenting
      • Intimacy
      • Preventing Abuse
  • d Research
    • d Participate in Research Studies
      • Participate in a Clinical Trial
      • Surveys and Other Research Studies
      • Participate in Genetic Studies
      • Donate to Tissue Banks
    • d Research News & Progress
      • Research News
      • Stem Cells in MS
      • Progressive MS Research
      • Clinical Trials in MS
      • Wellness and Lifestyle Research
      • Diet
      • Vitamin D
      • How and Why Do Scientists Share Results
    • d Research We Fund
      • Stopping MS In Its Tracks
      • Restoring What's Been Lost
      • Ending the Disease Forever
      • How We Fund Research
      • FAQs about Society Research
      • Past Research Efforts
      • Driving Solutions
    • d For Researchers
  • d Get Involved
    • d Volunteer
      • Volunteer Information
      • Volunteer Recognition
    • d Advocate for Change
      • Become an MS Activist
      • Take Action
      • Current Advocacy Issues
      • Advocacy Results
      • Advocacy News
    • d Raise Awareness
    • d Join the Community
    • d Stay Informed
    • d Corporate Support
      • Corporate Partners
      • National Teams
      • Partnership Opportunities
    • d Personal Stories
      • Life with MS
      • Givers
      • Shakers
      • Families with MS
      • Seekers
      • Movers
      • Tributes
  • d Donate
    • d Support an Event Participant
    • d Donate Online
    • d Give in Honor or Memory
    • d Workplace Giving
    • d Employer Matching Gifts
    • d Gifts of Stock or Securities
    • d Giving Circles
      • Golden Circle
      • Circle of Distinction
      • Lawry Circle
      • Circle of Influence
    • d Planned Giving
    • d Other Ways to Give
      • Donate by Mail or Phone
  • d About the Society
    • d Vision
      • Strategic Plan
      • Independent Review of Society's Research Programs
    • d Careers
    • d Leadership
      • Board of Directors
      • Senior Leadership Team
      • Founder Sylvia Lawry
    • d Cultural Values
    • d Financials
      • Annual Reports
      • Sources of Support
    • d News
    • d Press Room
      • Events at a Glance
      • MS the Disease
      • Public Service Announcements
      • In the News Archives
    • d MS Prevalence
      • MS Prevalence FAQs
    • d Charitable Ratings
    • d Corporate Support and Programs
  • d Helpful Links
    • d Información en Español
    • d Site Map
    • d Site Tour
    • d Contact Us
  • d For Professionals
    • d Researchers
      • Society Funding
      • Deadlines
      • Apply Online
      • Funding Policies and Procedures
      • Scientific Peer Reviewers
      • Resources for Researchers
    • d Professional Resource Center
      • About MS
      • Diagnosing MS
      • Managing MS
      • Resources for You and Your Practice
      • Publications for Clinicians
      • Publications for Your Patients
      • MS Navigator Program
      • Programs and Services for Your Patients
      • Contact Us
      • Clinical Fellows
    • d Careers in MS
      • Clinical Care
      • Research
      • Have you met?
  • d Our Healthcare Voice
HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

Share this page

FacebookTwitterEmail

Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

A Community Wellness Program for Adults Living With Long-term Physical Disability

Study Purpose

For people living with long-term physical disabilities, such as spinal cord injury or multiple sclerosis, middle-age (45-64) is a period of great vulnerability for losses in function and participation. There is an urgent need to develop and test interventions that can be delivered through existing community service agencies to help these people maximize their community participation and quality of life. This research will test the efficacy of one such intervention in a community trial and, thereby, contribute to our understanding of the intervention's effectiveness and mechanisms of action.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 45 Years - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 45 to 64 years of age at screening (turning 65 years after screening is ok); - Able to read, speak, and understand English; - Has a self-reported physician's diagnosis of long-term physical disability defined as: - a medical condition affecting the muscular or neurologic systems (eg, muscular dystrophy, multiple sclerosis, post-polio syndrome or spinal cord injury), and the condition: - creates functional disability (impairment in at least one activity of daily living (ADL) or at least one instrumental activity of daily living (IADL), as indicated by the Expanded Functional Disability Scale) - was present before age 40 years.
  • - Able to participate via telephone; - Has a goal in mind if randomized to the EW-D intervention; - Has not participated in the original EnhanceWellness intervention group.

Exclusion Criteria:

  • - Under 45 years of age or 65 or older at screening; - Unable to read, speak, or understand English; - Does not have a neurological or muscular condition affecting physical function (e.g., persons with low back pain and shoulder pain would be excluded); - Does not have functional disability; - Disability onset after age 40 years; - Significant cognitive impairment as defined by the Six-Item Screener; - Psychiatric condition or symptoms that would interfere with participation, specifically: - Current, active suicidal ideation with current intent to harm oneself, or.
  • - Current schizophrenia, psychosis, or mania.
  • - Unable to participate via telephone; - Does not have a goal if randomized to the EW-D intervention; - Has participated in the original EnhanceWellness intervention group.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03653390
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Washington
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ivan Molton, PhD
Principal Investigator Affiliation University of Washington
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Physical Disability
Additional Details

Middle-age (45-64) is a time of health vulnerability for millions of Americans. More than 50% of individuals in the U.S. will have two or more chronic conditions by age 60, contributing to increased risk of later disability. However, for individuals with long-term physical disabilities (LTPDs) such as spinal cord injury or multiple sclerosis, these risks are magnified. This vulnerable population is especially in need of interventions to promote community participation and improve disease self-management during midlife. Over the past 5 years, our research team has adapted an evidence-based health promotion intervention designed for older adults to serve middle-aged and older adults with LTPD. The investigators now have a trial version of this intervention (called "EnhanceWellness for Disability"; EW-D) with promising findings in pilot testing, ready for a larger community trial. Through a new partnership with 3 regional Centers for Independent Living, the investigators can now test this program for people with LTPD in 14 counties in the Northwest U.S.A. The broad, long-term aims of this study are to test the efficacy of this program relative to two control conditions (an attention-matched health education control and treatment as usual), in 600 community dwelling adults age 45-64 years with LTPD using modern outcome scales appropriate for people with LTPD. The primary outcome is the ability to participate in valued community activities. The investigators will seek to determine whether the intervention was effective and if so, what mechanisms of change drove the effect. In addition to self-report, the investigators will also collect objective measures of community activity via global positioning system (GPS) and travel diaries, in a randomly selected subset of 300 participants. This study's specific aims are as follows: Specific Aim 1. To determine the efficacy of eight sessions of EW-D, relative to an attention control condition or treatment as usual, in middle-aged adults with LTPD. The primary outcome will be the self-reported ability to participate in valued community activities. Specific Aim 2. To determine if observed intervention effects are due to

  • (1) improved disease management self-efficacy, (2) decreased interference due to pain and fatigue, or (3) improvements in psychological resilience.
Secondary Analyses. To determine if 1) intervention effects are maintained at 12 months and 2) intervention effects can be detected in objective, GPS-based measures of activity (quantified as number of trips outside the home, time outside the home, area of travel, and activity in established categories). The investigators will also examine the potential moderating effects of biological sex on treatment response. This approach is consistent with goals described in recent National Institute on Aging (NIA) and National Institute of Nursing Research (NINR) program announcements, including those calling for age-appropriate interventions to improve self-management of chronic conditions (PA 14-344) and those calling for prevention research for adults in midlife (PA-15-098). If hypotheses are confirmed, this work would support a program that could be used to promote health and wellness in both able-bodied older adults and middle-aged adults with LTPD, which would be novel to the field and could improve reach.

Arms & Interventions

Arms

Experimental: EnhanceWellness for Disability (EW-D)

Up to 10 sessions of a telephone-based intervention delivered over a six-month period.

Active Comparator: Wellness Education

Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period.

No Intervention: Control

Participant continues with their lives as they normally would.

Interventions

Behavioral: - EnhanceWellness for Disability (EW-D)

Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.

Behavioral: - Wellness Education

Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98195

Site Contact

Katie Singsank, BA

[email protected]

206-543-0110

Nearest Location

Site Contact

Katie Singsank, BA

[email protected]

206-543-0110


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Colophon

 

Stay Informed

Join Us

Facebook Twitter Instagram LinkedIn YouTube MS Connection
  • About the Society
    • Vision
    • Careers
    • Leadership
    • Cultural Values
    • Financials
    • News
    • Press Room
    • MS Prevalence
    • Charitable Ratings
    • Corporate Support
  • Helpful Links
    • Donate
    • MSConnection Blog
    • Información en Español
    • Glossary
    • Legal Notice/Privacy Policy
    • Site Map
    • Site Tour
    • Contact Us
  • For Professionals
    • Researchers
    • Physicians
    • Nurses
    • Rehabilitation Professionals
    • Mental Health Professionals
    • Health and Wellness Professionals
  • What Is MS?
  • Symptoms & Diagnosis
  • Treating MS
  • Resources & Support
  • Living Well with MS
  • Research
  • Get Involved
Hidden Link