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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02815878
Other study ID # 47035
Secondary ID
Status Completed
Phase N/A
First received June 22, 2016
Last updated March 30, 2018
Start date May 12, 2014
Est. completion date November 2017

Study information

Verified date October 2017
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form Self-reported measure of depression. Greater scores indicated greater depressive symptoms. 6-months
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