A Community Wellness Program for Adults Living With Long-term Physical Disability

Physical Disability Clinical Trial

— EW-D  

Official title:

Efficacy and Mechanism of a Community Wellness Promotion Program for Middle-aged Adults Living With Long-term Physical Disability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653390
• Other study ID #: STUDY00003931
• Secondary ID: R01NR016942-01
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: November 14, 2022

Study information

• Verified date: October 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Disability

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Change from baseline to 6 months
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)	Change from baseline to 3 months
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)	Change from baseline to 3 months
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)	Change from baseline to 3 months
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)	Change from baseline to 3 months
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	Change from baseline to 12 months
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.	Change from baseline to 12 months
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	Change from baseline to 12 months
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	Change from baseline to 12 months
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)	Change from baseline to 12 months