A Community Wellness Program for Adults Living With Long-term Physical
Efficacy and Mechanism of a Community Wellness Promotion Program for Middle-aged Adults Living With Long-term Physical Disability
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | <0.01 | ||
| Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | Mean Difference (Net) -2.40 | -3.85–-0.95 | <0.01 |
| Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | Mean Difference (Net) -1.24 | -2.71–0.22 | 0.11 |
| Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | Mean Difference (Net) -1.16 | -2.64–0.32 | 0.16 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- EnhanceWellness for Disability (EW-D)
Compared with
- Wellness Education
Results by group
Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months
Change from baseline to 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | 2.49 score on a scale | 5.95 (Standard Deviation) | 161 |
| Wellness Education | 1.25 score on a scale | 5.58 (Standard Deviation) | 148 |
| Control | 0.09 score on a scale | 4.8 (Standard Deviation) | 154 |
EnhanceWellness for Disability (EW-D)
Wellness Education
Control
p = <0.01
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | 183 | 12 (6.6%) | 1 |
| Wellness Education | 159 | 13 (8.2%) | 0 |
| Control | 163 | 3 (1.8%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months
Change from baseline to 6 months
Quality of life (reported by participants)
Other measures (9)
Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months
Change from baseline to 3 months
Change in Self-reported Interference Due to Pain From Baseline to 3 Months
Change from baseline to 3 months
PainQuality of life (reported by participants)Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months
Change from baseline to 3 months
FatigueQuality of life (reported by participants)Change in Psychological Resilience From Baseline to 3 Months
Change from baseline to 3 months
Change in Number of Trips Outside the Home From Baseline to 12 Months
Change from baseline to 12 months
Change in Radius of Gyration From Baseline to 12 Months
Change from baseline to 12 months
Walking and mobilityChange in Number of Trips Outside the Home Containing "Social" Elements From Baseline to 12 Months
Change from baseline to 12 months
Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months
Change from baseline to 12 months
Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months
Change from baseline to 12 months
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 45 to 64
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jan 2019
Main results due
Nov 2022
Finished
Nov 2022
Results posted
Nov 2023