Clinical trial NCT03653390: A Community Wellness Program for Adults Living With Long-term Physical Disability
Official title: Efficacy and Mechanism of a Community Wellness Promotion Program for Middle-aged Adults Living With Long-term Physical Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: health promotion intervention
community participation
quality of life
middle age
multiple sclerosis
spinal cord injury
muscular dystrophy
post-polio syndrome
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-08-31
Enrollment: 516
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months
timeFrame: Change from baseline to 3 months
measure: Change in Self-reported Interference Due to Pain From Baseline to 3 Months
timeFrame: Change from baseline to 3 months
measure: Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months
timeFrame: Change from baseline to 3 months
measure: Change in Psychological Resilience From Baseline to 3 Months
timeFrame: Change from baseline to 3 months
measure: Change in Number of Trips Outside the Home From Baseline to 12 Months
timeFrame: Change from baseline to 12 months
measure: Change in Radius of Gyration From Baseline to 12 Months
timeFrame: Change from baseline to 12 months
measure: Change in Number of Trips Outside the Home Containing "Social" Elements From Baseline to 12 Months
timeFrame: Change from baseline to 12 months
measure: Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months
timeFrame: Change from baseline to 12 months
measure: Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months
timeFrame: Change from baseline to 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ivan Molton, PhD
role: PRINCIPAL_INVESTIGATOR
References: