Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||45 Years - 64 Years|
More Inclusion & Exclusion 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Washington|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ivan Molton, PhD|
|Principal Investigator Affiliation||University of Washington|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms & Interventions
Experimental: EnhanceWellness for Disability (EW-D)
Up to 10 sessions of a telephone-based intervention delivered over a six-month period.
Active Comparator: Wellness Education
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period.
No Intervention: Control
Participant continues with their lives as they normally would.
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.
Behavioral: - 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.