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

NCT03653390 | Completed Results DMC

• 2 other identifiers: STUDY00003931R01NR016942-01
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Disability

Keywords

health promotion intervention; community participation; quality of life; middle age; multiple sclerosis; spinal cord injury; muscular dystrophy; post-polio syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months

  Change from baseline to 3 months

• Change in Self-reported Interference Due to Pain From Baseline to 3 Months

  Change from baseline to 3 months

• Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months

  Change from baseline to 3 months

• Change in Psychological Resilience From Baseline to 3 Months

  Change from baseline to 3 months

• Change in Number of Trips Outside the Home From Baseline to 12 Months

  Change from baseline to 12 months

Study Arms (3)

EnhanceWellness for Disability (EW-D)

EXPERIMENTAL

Up to 10 sessions of a telephone-based intervention delivered over a six-month period.

Behavioral: EnhanceWellness for Disability (EW-D)

Wellness Education

ACTIVE COMPARATOR

Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period.

Behavioral: Wellness Education

Control

NO INTERVENTION

Participant continues with their lives as they normally would.

Interventions

EnhanceWellness for Disability (EW-D) BEHAVIORAL

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.

EnhanceWellness for Disability (EW-D)

Wellness Education BEHAVIORAL

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.

Wellness Education

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Spinal Cord Injuries; Muscular Dystrophies; Postpoliomyelitis Syndrome

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases

Limitations and Caveats

Majority of participant recruitment took place during global COVID 19 pandemic which conceivably could have influenced participant outcomes in ways that could not be measured.

Results Point of Contact

• Title: Dr. Ivan Molton, PhD
• Organization: University of Washington

imolton@uw.edu

2065433602

Study Officials

• Ivan Molton, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine:Psychology

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 31, 2018
• Study Start: January 31, 2019
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)