Enhance Wellness for Individuals With Long-Term Physical Disabilities

NCT02815878 | Completed

• 1 other identifier: 47035
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Muscular Dystrophy; Post-polio Syndrome; Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  6-months

• Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form

  Self-reported measure of depression. Greater scores indicated greater depressive symptoms.

  6-months

Study Arms (3)

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.

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.

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.

Interventions

Enhance Wellness BEHAVIORAL

A 6-month health promotion intervention which pairs participants with a wellness coach to identify and pursue a health-related goal of their choosing.

Group 1: Intervention with Disability; Group 2: Intervention without Disability

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active suicidal ideation
• Requires the use of a mechanical ventilator to breathe or speak

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscular Dystrophies; Postpoliomyelitis Syndrome; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ivan R Molton, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 28, 2016
• Study Start: May 12, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 3, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)