Physical DisabilityEW-DNCT03653390
A Community Wellness Program for Adults Living With Long-term Physical Disability
A study testing EnhanceWellness for Disability (EW-D) and Wellness Education in people with Physical Disability, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- EnhanceWellness for Disability (EW-D) and Wellness Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Mechanism of a Community Wellness Promotion Program for Middle-aged Adults Living With Long-term Physical Disability
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.
Read the 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.
- Conditions
- Physical Disability
- Being tested
- EnhanceWellness for Disability (EW-D), Wellness Education
- Keywords
- health promotion intervention, community participation, quality of life, middle age, multiple sclerosis, spinal cord injury, muscular dystrophy, post-polio syndrome
- Medical subject headings
- Multiple Sclerosis, Spinal Cord Injuries, Muscular Dystrophies, Postpoliomyelitis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnhanceWellness for Disability (EW-D)Behavioural
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.
Wellness EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EnhanceWellness for Disability (EW-D) | Experimental | Up to 10 sessions of a telephone-based intervention delivered over a six-month period. Receives: Behavioral: EnhanceWellness for Disability (EW-D) |
| Wellness Education | Active comparator | Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Receives: Behavioral: Wellness Education |
| Control | No intervention | Participant continues with their lives as they normally would. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline to 6 months
Secondary outcomes (9)
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)
Measured: Change from baseline to 3 months
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)
Measured: Change from baseline to 3 months
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)
Measured: Change from baseline to 3 months
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)
Measured: Change from baseline to 3 months
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
Measured: Change from baseline to 12 months
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.
Measured: Change from baseline to 12 months
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
Measured: Change from baseline to 12 months
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
Measured: Change from baseline to 12 months
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)
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start31 Jan 2019
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Ivan Molton, University of Washington
- Investigators
- Ivan Molton, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653390
- Sponsor's protocol ID
- STUDY00003931
- Other IDs
- R01NR016942-01
- Acronym
- EW-D
- Status last verified
- Oct 2023
- First submitted
- 10 Jul 2018
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators propose to make available to interested researchers a data file (de-identified to remove any variables from which it would be possible to identify any individual participant) any data used in a published article, at the time that it is accepted for publication. That is, at the request of an outside researcher, the investigators will create and share a data file that includes all of the variables used in the published article and a list of the variables in the data file (along with their variable labels). Any investigators who request these data will receive (1) a copy of the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a data set.
Publications
Molton IR, Singsank K, Rivera N, Munroe LA, Flaster A, Humbert A, Daymon D, Thompson M, Yang B, Denison P. Can We Borrow Your Intervention? Randomized Controlled Trial of an Older Adult Telehealth Wellness Promotion Program Adapted for Middle-Aged Adults With Physical Disability. Gerontologist. 2025 Jun 12;65(7):gnaf079. doi: 10.1093/geront/gnaf079.
PubMed 39969182
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of a Community Wellness Promotion Program for Middle-aged Adults Living With Long-term Physical Disability
- ClinicalTrials.gov ID
- NCT03653390
- Acronym / sponsor ID
- EW-D / STUDY00003931
- Conditions
- Physical Disability
- Keywords
- health promotion intervention, community participation, quality of life, middle age, multiple sclerosis, spinal cord injury, muscular dystrophy, post-polio syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EnhanceWellness for Disability (EW-D) | Experimental | Behavioral: EnhanceWellness for Disability (EW-D)Up to 10 sessions of a telephone-based intervention delivered over a six-month period. |
| Wellness Education | Active comparator | Behavioral: Wellness EducationEight 45-minute sessions of telephone-based wellness education delivered over a six-month period. |
| Control | No intervention | –Participant continues with their lives as they normally would. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- Able to participate via telephone;
- Has a goal in mind if randomized to the EW-D intervention;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | EnhanceWellness for Disability (EW-D) |
| Wellness EducationSessions 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. | Behavioural | Wellness Education |
Primary outcome
Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months
Time frame: 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)
9 secondary outcomes
Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months
Time frame: Change from baseline to 3 months
Change in Self-reported Interference Due to Pain From Baseline to 3 Months
Time frame: Change from baseline to 3 months
Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months
Time frame: Change from baseline to 3 months
Change in Psychological Resilience From Baseline to 3 Months
Time frame: Change from baseline to 3 months
Change in Number of Trips Outside the Home From Baseline to 12 Months
Time frame: Change from baseline to 12 months
Change in Radius of Gyration From Baseline to 12 Months
Time frame: Change from baseline to 12 months
Change in Number of Trips Outside the Home Containing "Social" Elements From Baseline to 12 Months
Time frame: Change from baseline to 12 months
Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months
Time frame: Change from baseline to 12 months
Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months
Time frame: Change from baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39969182Molton IR, Singsank K, Rivera N, Munroe LA, Flaster A, Humbert A, Daymon D, Thompson M, Yang B, Denison P. Can We Borrow Your Intervention? Randomized Controlled Trial of an Older Adult Telehealth Wellness Promotion Program Adapted for Middle-Aged Adults With Physical Disability. Gerontologist. 2025 Jun 12;65(7):gnaf079. doi: 10.1093/geront/gnaf079.
- Individual participant dataSharing planned: Yes. The investigators propose to make available to interested researchers a data file (de-identified to remove any variables from which it would be possible to identify any individual participant) any data used in a published article, at the time that it is accepted for publication. That is, at the request of an outside researcher, the investigators will create and share a data file that includes all of the variables used in the published article and a list of the variables in the data file (along with their variable labels). Any investigators who request these data will receive (1) a copy of the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a data set.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Molton, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnhanceWellness for Disability (EW-D) and Wellness Education in people with Physical Disability, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.