Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Community Wellness Program for Adults Living With Long-term Physical Disability (EW-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653390
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Ivan Molton, University of Washington

Tracking Information
First Submitted Date  ICMJE July 10, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE January 31, 2019
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • Community participation (self-report) [ Time Frame: Baseline ]
    Complete a standardized measure: 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)
  • Community participation (self-report) [ Time Frame: 3 months ]
    Complete a standardized measure: 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)
  • Community participation (self-report) [ Time Frame: 6 months ]
    Complete a standardized measure: 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)
  • Community participation (self-report) [ Time Frame: 12 months ]
    Complete a standardized measure: 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)
  • Community Participation (measured) [ Time Frame: Baseline ]
    Global Positioning System (GPS) measurement
  • Community Participation (measured) [ Time Frame: 12 months ]
    Global Positioning System (GPS) measurement
  • Community Participation (measured) [ Time Frame: Baseline ]
    Self-report travel diary
  • Community Participation (measured) [ Time Frame: 12 months ]
    Self-report travel diary
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • Disease management self-efficacy [ Time Frame: Baseline ]
    Complete a standardized measure: University of Washington Self-Efficacy Scale. Higher score indicates better self-efficacy (total score range: 6-30)
  • Disease management self-efficacy [ Time Frame: 3 months ]
    Complete a standardized measure: University of Washington Self-Efficacy Scale. Higher score indicates better self-efficacy (total score range: 6-30)
  • Disease management self-efficacy [ Time Frame: 6 months ]
    Complete a standardized measure: University of Washington Self-Efficacy Scale. Higher score indicates better self-efficacy (total score range: 6-30)
  • Disease management self-efficacy [ Time Frame: 12 months ]
    Complete a standardized measure: University of Washington Self-Efficacy Scale. Higher score indicates better self-efficacy (total score range: 6-30)
  • Pain and fatigue interference [ Time Frame: Baseline ]
    Complete standardized measures: Patient-Reported Outcomes Measurement Information System Pain Interference short form and Patient-Reported Outcomes Measurement Information System Fatigue short form. Higher scores indicate more pain and more fatigue (total score range: 4-20)
  • Pain and fatigue interference [ Time Frame: 3 months ]
    Complete standardized measures: Patient-Reported Outcomes Measurement Information System Pain Interference short form and Patient-Reported Outcomes Measurement Information System Fatigue short form. Higher scores indicate more pain and more fatigue (total score range: 4-20)
  • Pain and fatigue interference [ Time Frame: 6 months ]
    Complete standardized measures: Patient-Reported Outcomes Measurement Information System Pain Interference short form and Patient-Reported Outcomes Measurement Information System Fatigue short form. Higher scores indicate more pain and more fatigue (total score range: 4-20)
  • Pain and fatigue interference [ Time Frame: 12 months ]
    Complete standardized measures: Patient-Reported Outcomes Measurement Information System Pain Interference short form and Patient-Reported Outcomes Measurement Information System Fatigue short form. Higher scores indicate more pain and more fatigue (total score range: 4-20)
  • Resilience [ Time Frame: Baseline ]
    Complete a standardized measure: Connor-Davidson Resilience Scale 10-item short form. Higher score indicates more resilience (total score range: 0-40)
  • Resilience [ Time Frame: 3 months ]
    Complete a standardized measure: Connor-Davidson Resilience Scale 10-item short form. Higher score indicates more resilience (total score range: 0-40)
  • Resilience [ Time Frame: 6 months ]
    Complete a standardized measure: Connor-Davidson Resilience Scale 10-item short form. Higher score indicates more resilience (total score range: 0-40)
  • Resilience [ Time Frame: 12 months ]
    Complete a standardized measure: Connor-Davidson Resilience Scale 10-item short form. Higher score indicates more resilience (total score range: 0-40)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Community Wellness Program for Adults Living With Long-term Physical Disability
Official Title  ICMJE Efficacy and Mechanism of a Community Wellness Promotion Program for Middle-aged Adults Living With Long-term Physical Disability
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Physical Disability
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: EnhanceWellness for Disability (EW-D)
    Up to 10 sessions of a telephone-based intervention delivered over a six-month period.
    Intervention: Behavioral: EnhanceWellness for Disability (EW-D)
  • Active Comparator: Wellness Education
    Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period.
    Intervention: Behavioral: Wellness Education
  • No Intervention: Control
    Participant continues with their lives as they normally would.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katie Singsank, BA 206-543-0110 singsank@uw.edu
Contact: Aaron Flaster, BA 206-616-7934 aflaster@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03653390
Other Study ID Numbers  ICMJE STUDY00003931
R01NR016942-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Data will become available after the main study results are published.
Access Criteria: Although any shared data will be stripped of identifiers prior to release, given the very specific nature of the study sample (middle-aged adults with disabilities) it is possible that those who access this data could potentially identify subjects with unusual characteristics or combinations of unusual characteristics. Therefore, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Responsible Party Ivan Molton, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Ivan Molton, PhD University of Washington
PRS Account University of Washington
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP