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



Status:Not yet recruiting
Healthy:No
Age Range:45 - 64
Updated:9/2/2018
Start Date:October 1, 2018
End Date:December 31, 2020
Contact:Rana Salem, MA
Email:rsalem@uw.edu
Phone:206-462-5070

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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.

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.

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) and 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.
We found this trial at
1
site
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Ivan Molton, PhD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
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