Functional Decline After Injury Clinical Trial
— Elderly CRASHOfficial title:
Persistent Pain and Associated Functional Decline Among Elderly Experiencing Motor Vehicle Collision
| Verified date | April 2017 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Chronic problems after traumatic events are common in non-elderly adults. Previous studies have shown that after minor motor vehicle collision (MVC), 10-30% of non-elderly adult patients develop chronic regional pain (neck or back pain). In addition, up to 1/3 of non-elderly adults will develop psychological sequelae, including posttraumatic stress disorder, depression, and anxiety disorders. There have been no prospective studies examining the frequency or predictors of persistent pain or psychological sequelae in older adults. The proposed study seeks to determine the frequency of persistent pain, psychological sequelae, and associated disability in older adults after minor MVC trauma and to identify candidate predictors for a model of adverse outcomes after MVC in this population. 200 individuals over 65 years of age will be recruited from emergency departments in four states with no-fault accident laws. Patients who meet inclusion criteria and who consent to the emergency department (ED) study will undergo a 30-45 minute ED assessment of crash-related, psychosocial, and biological factors, and complete telephone follow-ups at 2 weeks, 6 weeks 6 months, and 12 months. The wealth of information gained from this study will be used to determine the frequency of adverse events in older adults after MVC and to identify high risk elderly patients. These results will inform subsequent development of secondary pharmacologic and/or behavioral interventions to prevent chronic pain and psychological sequelae after traumatic events in older adults.
| Status | Completed |
| Enrollment | 211 |
| Est. completion date | November 2017 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: - Patient speaks English, presented to ER less than 24 hours after an MVC, patient has an address and telephone Exclusion Criteria: - Patient - is a prisoner, - has fractures or an intracranial injury, - has injuries that are life threatening or expected to result in hospitalization for more than 72 hours, - is receiving end of life, hospice, or comfort care, or - is considered ineligible by treating physician. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Spectrum Health - Butterworth Hospital | Grand Rapids | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | National Institute on Aging (NIA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average pain 6 months after Emergency Department visit | Average pain during the past week with pain measured on a 0-10 scale. | 6 months | |
| Secondary | Physical function at 6 months after Emergency Department visit | Function measured on a 0-12 scale based on patient reported ability or difficulty walking, carrying objects, and climbing stairs (Simonsick E, et al. 2001). | 6 months |