N/A
N=505
A Community Wellness Program for Adults Living With Long-term Physical Disability
Physical Disability
Bottom Line
View on ClinicalTrials.gov: NCT03653390 ↗Enrolled (actual)
505
Serious AEs
5.5%
Results posted
Nov 2023
Primary outcome: Primary: Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months — 2.49; 1.25; 0.09 score on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EnhanceWellness for Disability (EW-D) (Behavioral); Wellness Education (Behavioral)
- Age
- Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months |
2.49; 1.25; 0.09 | <0.01 sig |
| SECONDARY Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months |
2.19; 0.01; -0.07 | <0.01 sig |
| SECONDARY Change in Self-reported Interference Due to Pain From Baseline to 3 Months |
-1.22; -0.55; -0.23 | 0.382 |
| SECONDARY Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months |
-1.89; -1.09; -0.76 | 0.29 |
| SECONDARY Change in Psychological Resilience From Baseline to 3 Months |
0.44; 0.28; -0.77 | 0.057 |
| SECONDARY Change in Number of Trips Outside the Home From Baseline to 12 Months |
-0.25; -0.12; 0.03 | 0.21 |
| SECONDARY Change in Radius of Gyration From Baseline to 12 Months |
6328; 6598; 19917 | 0.79 |
| SECONDARY Change in Number of Trips Outside the Home Containing "Social" Elements From Baseline to 12 Months |
-0.18; -0.10; 0.02 | 0.26 |
| SECONDARY Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months |
-30.1; -58.8; 36.5 | <0.01 sig |
| SECONDARY Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months |
2.89; 1.34; 0.74 | <0.01 sig |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03653390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.