Physical Disability
Conditions
Keywords
health promotion intervention, community participation, quality of life, middle age, multiple sclerosis, spinal cord injury, muscular dystrophy, post-polio syndrome
Brief 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.
Detailed description
Middle-age (45-64) is a time of health vulnerability for millions of Americans. More than 50% of individuals in the U.S. will have two or more chronic conditions by age 60, contributing to increased risk of later disability. However, for individuals with long-term physical disabilities (LTPDs) such as spinal cord injury or multiple sclerosis, these risks are magnified. This vulnerable population is especially in need of interventions to promote community participation and improve disease self-management during midlife. Over the past 5 years, our research team has adapted an evidence-based health promotion intervention designed for older adults to serve middle-aged and older adults with LTPD. The investigators now have a trial version of this intervention (called EnhanceWellness for Disability; EW-D) with promising findings in pilot testing, ready for a larger community trial. Through a new partnership with 3 regional Centers for Independent Living, the investigators can now test this program for people with LTPD in 14 counties in the Northwest U.S.A. The broad, long-term aims of this study are to test the efficacy of this program relative to two control conditions (an attention-matched health education control and treatment as usual), in 600 community dwelling adults age 45-64 years with LTPD using modern outcome scales appropriate for people with LTPD. The primary outcome is the ability to participate in valued community activities. The investigators will seek to determine whether the intervention was effective and if so, what mechanisms of change drove the effect. In addition to self-report, the investigators will also collect objective measures of community activity via global positioning system (GPS) and travel diaries, in a randomly selected subset of 300 participants. This study's specific aims are as follows: Specific Aim 1. To determine the efficacy of eight sessions of EW-D, relative to an attention control condition or treatment as usual, in middle-aged adults with LTPD. The primary outcome will be the self-reported ability to participate in valued community activities. Specific Aim 2. To determine if observed intervention effects are due to (1) improved disease management self-efficacy, (2) decreased interference due to pain and fatigue, or (3) improvements in psychological resilience. Secondary Analyses. To determine if 1) intervention effects are maintained at 12 months and 2) intervention effects can be detected in objective, GPS -based measures of activity (quantified as number of trips outside the home, time outside the home, area of travel, and activity in established categories). The investigators will also examine the potential moderating effects of biological sex on treatment response. This approach is consistent with goals described in recent National Institute on Aging (NIA) and National Institute of Nursing Research (NINR) program announcements, including those calling for age-appropriate interventions to improve self-management of chronic conditions (PA 14-344) and those calling for prevention research for adults in midlife (PA-15-098). If hypotheses are confirmed, this work would support a program that could be used to promote health and wellness in both able-bodied older adults and middle-aged adults with LTPD, which would be novel to the field and could improve reach.
Interventions
BEHAVIORALEnhanceWellness for Disability (EW-D)
Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
BEHAVIORALWellness Education
Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | Change from baseline to 6 months | Change in perceived ability to participate in community activities from baseline to 6 months. Assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities short form (APSR). Higher scores indicate better ability to participate in social activities (total score range: 8-40) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Interference Due to Pain From Baseline to 3 Months | Change from baseline to 3 months | Change in self-report of interference due to pain from baseline to 3 months, assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) short form. Higher scores indicate more pain interference (total score range: 4-20) |
| Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months | Change from baseline to 3 months | Change in self-report of interference due to fatigue, from baseline to 3 months, assessed via the Patient-Reported Outcomes Measurement Information System Fatigue Interference short form. Higher scores indicate more fatigue interference (total score range: 4-20) |
| Change in Psychological Resilience From Baseline to 3 Months | Change from baseline to 3 months | Change in self-report of psychological resilience, assessed via the Connor-Davidson Resilience Scale 10-item short form. Higher score indicates more resilience (total score range: 0-40) |
| Change in Number of Trips Outside the Home From Baseline to 12 Months | Change from baseline to 12 months | Change in the average number of trips per day outside the home based on GPS data |
| 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 confidence in managing chronic illness, measured via the University of Washington Self-Efficacy Scale. Higher score indicates better self-efficacy (total score range: 6-30) |
| Change in Number of Trips Outside the Home Containing Social Elements From Baseline to 12 Months | Change from baseline to 12 months | Change in the average number of trips per day outside the home containing social elements based on GPS and travel log data |
| 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 average time per day spent in activities outside the home containing social elements from baseline to 12 months based on GPS and travel log data |
| Change in Self-reported Ability to Participate in Community Activities 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. Assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities short form (APSR). Higher scores indicate better ability to participate in social activities (total score range: 8-40) |
| Change in Radius of Gyration From Baseline to 12 Months | Change from baseline to 12 months | Radius of Gyration refers to a metric of activity space or overall mobility distance, calculated by creating a shape representing the area of daily travel, with a central index point, based on GPS data. |
Countries
United States
Participant flow
Pre-assignment details
After enrollment and prior to group assignment, participants complete the baseline survey. Because participants have the option to withdraw at any time, some may choose to withdraw or are lost to follow up prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| EnhanceWellness for Disability (EW-D) Up to 10 sessions of a telephone-based intervention delivered over a six-month period.
EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time. | 183 |
| Wellness Education Eight sessions of telephone-based wellness education delivered over a six-month period.
Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations. | 159 |
| Control Participant continues with their lives as they normally would. | 163 |
| Total | 505 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 12 | 8 | 7 |
| Overall Study | Paper Survey Lost | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 1 | 1 |
Baseline characteristics
| Characteristic | EnhanceWellness for Disability (EW-D) | Wellness Education | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 183 Participants | 159 Participants | 163 Participants | 505 Participants |
| PROMIS Ability to Participate in Social Roles & Activities v2.0 Short Form 8a | 41.16 T-score STANDARD_DEVIATION 7.79 | 41.90 T-score STANDARD_DEVIATION 6.39 | 41.77 T-score STANDARD_DEVIATION 7.36 | 41.60 T-score STANDARD_DEVIATION 7.22 |
| Race/Ethnicity, Customized American Indian / Alaska Native | 7 Participants | 3 Participants | 2 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian / Asian American | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Black / African American | 14 Participants | 9 Participants | 12 Participants | 35 Participants |
| Race/Ethnicity, Customized Hawaiian Native / Pacific Islander | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 7 Participants | 6 Participants | 19 Participants |
| Race/Ethnicity, Customized Not Hispanic | 176 Participants | 151 Participants | 156 Participants | 483 Participants |
| Race/Ethnicity, Customized Other (Ethnicity) | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other (Race) | 3 Participants | 2 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Prefer not to Answer (Hispanic) | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Prefer not to Answer (Race) | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White / Caucasian | 162 Participants | 145 Participants | 144 Participants | 451 Participants |
| Region of Enrollment Canada | 1 participants | 1 participants | 2 participants | 4 participants |
| Region of Enrollment United States | 182 participants | 158 participants | 161 participants | 501 participants |
| Sex/Gender, Customized Female | 145 Participants | 117 Participants | 127 Participants | 389 Participants |
| Sex/Gender, Customized Male | 37 Participants | 42 Participants | 35 Participants | 114 Participants |
| Sex/Gender, Customized Not Listed | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Prefer not to Answer | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Transgender | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 183 | 0 / 159 | 0 / 163 |
| other Total, other adverse events | 45 / 183 | 9 / 159 | 0 / 163 |
| serious Total, serious adverse events | 12 / 183 | 13 / 159 | 3 / 163 |
Outcome results
Primary
Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months
Change in perceived ability to participate in community activities from baseline to 6 months. Assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities short form (APSR). Higher scores indicate better ability to participate in social activities (total score range: 8-40)
Time frame: Change from baseline to 6 months
Population: All participants with a PROMIS APSR value at both baseline and 6 months were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | 2.49 score on a scale | Standard Deviation 5.95 |
| Wellness Education | Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | 1.25 score on a scale | Standard Deviation 5.58 |
| Control | Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months | 0.09 score on a scale | Standard Deviation 4.8 |
p-value: <0.01ANOVA
p-value: 0.1195% CI: [-2.71, 0.22]Tukey's HSD test
p-value: <0.0195% CI: [-3.85, -0.95]Tukey's HSD test
p-value: 0.1695% CI: [-2.64, 0.32]Tukey's HSD test
Secondary
Change in Number of Trips Outside the Home Containing Social Elements From Baseline to 12 Months
Change in the average number of trips per day outside the home containing social elements based on GPS and travel log data
Time frame: Change from baseline to 12 months
Population: All participants with an average trips per day outside the home containing social elements measure at baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Number of Trips Outside the Home Containing Social Elements From Baseline to 12 Months | -0.18 social trips outside the home M per day | Standard Deviation 0.49 |
| Wellness Education | Change in Number of Trips Outside the Home Containing Social Elements From Baseline to 12 Months | -0.10 social trips outside the home M per day | Standard Deviation 0.41 |
| Control | Change in Number of Trips Outside the Home Containing Social Elements From Baseline to 12 Months | 0.02 social trips outside the home M per day | Standard Deviation 0.72 |
p-value: 0.26ANOVA
Secondary
Change in Number of Trips Outside the Home From Baseline to 12 Months
Change in the average number of trips per day outside the home based on GPS data
Time frame: Change from baseline to 12 months
Population: All participants with GPS data at baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Number of Trips Outside the Home From Baseline to 12 Months | -0.25 trips per day outside the home | Standard Deviation 0.84 |
| Wellness Education | Change in Number of Trips Outside the Home From Baseline to 12 Months | -0.12 trips per day outside the home | Standard Deviation 0.48 |
| Control | Change in Number of Trips Outside the Home From Baseline to 12 Months | 0.03 trips per day outside the home | Standard Deviation 0.83 |
p-value: 0.21ANOVA
Secondary
Change in Psychological Resilience From Baseline to 3 Months
Change in self-report of psychological resilience, assessed via the Connor-Davidson Resilience Scale 10-item short form. Higher score indicates more resilience (total score range: 0-40)
Time frame: Change from baseline to 3 months
Population: All participants with a Connor-Davidson Resilience score at baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Psychological Resilience From Baseline to 3 Months | 0.44 score on a scale | Standard Deviation 5.61 |
| Wellness Education | Change in Psychological Resilience From Baseline to 3 Months | 0.28 score on a scale | Standard Deviation 4.62 |
| Control | Change in Psychological Resilience From Baseline to 3 Months | -0.77 score on a scale | Standard Deviation 4.2 |
p-value: 0.057ANOVA
Secondary
Change in Radius of Gyration From Baseline to 12 Months
Radius of Gyration refers to a metric of activity space or overall mobility distance, calculated by creating a shape representing the area of daily travel, with a central index point, based on GPS data.
Time frame: Change from baseline to 12 months
Population: All participants with GPS data at baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Radius of Gyration From Baseline to 12 Months | 6328 meters | Standard Deviation 25527 |
| Wellness Education | Change in Radius of Gyration From Baseline to 12 Months | 6598 meters | Standard Deviation 105587 |
| Control | Change in Radius of Gyration From Baseline to 12 Months | 19917 meters | Standard Deviation 154597 |
p-value: 0.79ANOVA
Secondary
Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months
Change in self-reported ability to participate in community activities from baseline to 12 months. Assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities short form (APSR). Higher scores indicate better ability to participate in social activities (total score range: 8-40)
Time frame: Change from baseline to 12 months
Population: All participants with a PROMIS APSR value at both baseline and 12 months were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months | 2.89 score on a scale | Standard Deviation 4.92 |
| Wellness Education | Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months | 1.34 score on a scale | Standard Deviation 5.12 |
| Control | Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months | 0.74 score on a scale | Standard Deviation 5.65 |
p-value: <0.01ANOVA
p-value: 0.02895% CI: [-2.97, -0.13]Tukey's HSD test
p-value: <0.0195% CI: [-3.55, -0.75]Tukey's HSD test
p-value: 0.5995% CI: [-2.03, 0.83]Tukey's HSD test
Secondary
Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months
Change in self-report of interference due to fatigue, from baseline to 3 months, assessed via the Patient-Reported Outcomes Measurement Information System Fatigue Interference short form. Higher scores indicate more fatigue interference (total score range: 4-20)
Time frame: Change from baseline to 3 months
Population: All participants with a PROMIS fatigue measure at baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months | -1.89 score on a scale | Standard Deviation 6.81 |
| Wellness Education | Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months | -1.09 score on a scale | Standard Deviation 6.85 |
| Control | Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months | -0.76 score on a scale | Standard Deviation 6.26 |
p-value: 0.29ANOVA
Secondary
Change in Self-reported Interference Due to Pain From Baseline to 3 Months
Change in self-report of interference due to pain from baseline to 3 months, assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) short form. Higher scores indicate more pain interference (total score range: 4-20)
Time frame: Change from baseline to 3 months
Population: All participants with a PROMIS PI value at both baseline and 3 months were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Self-reported Interference Due to Pain From Baseline to 3 Months | -1.22 score on a scale | Standard Deviation 6.47 |
| Wellness Education | Change in Self-reported Interference Due to Pain From Baseline to 3 Months | -0.55 score on a scale | Standard Deviation 6.7 |
| Control | Change in Self-reported Interference Due to Pain From Baseline to 3 Months | -0.23 score on a scale | Standard Deviation 6.66 |
p-value: 0.382ANOVA
Secondary
Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months
Change in confidence in managing chronic illness, measured via the University of Washington Self-Efficacy Scale. Higher score indicates better self-efficacy (total score range: 6-30)
Time frame: Change from baseline to 3 months
Population: All participants with a University of Washington Self-Efficacy Scale value at both baseline and 3 months were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months | 2.19 score on a scale | Standard Deviation 7.95 |
| Wellness Education | Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months | 0.01 score on a scale | Standard Deviation 7.06 |
| Control | Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months | -0.07 score on a scale | Standard Deviation 6.16 |
p-value: <0.01ANOVA
p-value: 0.01895% CI: [-4.05, -0.3]Tukey's HSD test
p-value: 0.01295% CI: [-4.12, -0.41]Tukey's HSD test
p-value: 0.9995% CI: [-1.98, 1.81]Tukey's HSD test
Secondary
Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months
Change in average time per day spent in activities outside the home containing social elements from baseline to 12 months based on GPS and travel log data
Time frame: Change from baseline to 12 months
Population: All participants with an average time per day spent in activities outside the home containing social elements measure at baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnhanceWellness for Disability (EW-D) | Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months | -30.1 minutes | Standard Deviation 96 |
| Wellness Education | Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months | -58.8 minutes | Standard Deviation 145.2 |
| Control | Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months | 36.5 minutes | Standard Deviation 127.9 |
p-value: <0.01ANOVA
p-value: 0.5795% CI: [-95.7, 38.4]Tukey's HSD test
p-value: 0.04895% CI: [0.56, 132.6]Tukey's HSD test
p-value: <0.0195% CI: [31.8, 158.7]Tukey's HSD test