Back to resultsEnhance Wellness for Individuals With Long-Term Physical Disabilities
Primary Purpose
Multiple Sclerosis, Muscular Dystrophy, Post-polio Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhance Wellness
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Active suicidal ideation
- Requires the use of a mechanical ventilator to breathe or speak
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Group 1: Intervention with Disability
Group 2: Intervention without Disability
Group 3: No intervention
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form
Self-reported measure of pain interference. Greater score indicate greater pain interference.
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form
Self-reported measure of depression. Greater scores indicated greater depressive symptoms.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02815878
Brief Title
Enhance Wellness for Individuals With Long-Term Physical Disabilities
Official Title
Project Enhance for Adults Aging With Long-Term Physical Disability
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 12, 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Muscular Dystrophy, Post-polio Syndrome, Spinal Cord Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Intervention with Disability
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Intervention without Disability
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3: No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhance Wellness
Intervention Description
A 6-month health promotion intervention which pairs participants with a wellness coach to identify and pursue a health-related goal of their choosing.
Primary Outcome Measure Information:
Title
Questionnaire: Level of reported self-efficacy as measured by the University of Washington Self-Efficacy Scale Questionnaire
Description
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.
Time Frame
6-months
Title
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form
Description
Self-reported measure of pain interference. Greater score indicate greater pain interference.
Time Frame
6-months
Title
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form
Description
Self-reported measure of depression. Greater scores indicated greater depressive symptoms.
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Active suicidal ideation
Requires the use of a mechanical ventilator to breathe or speak
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan R Molton, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Enhance Wellness for Individuals With Long-Term Physical Disabilities
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