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Clinical Trials/NCT03059602
NCT03059602
Completed
Not Applicable

Characterizing the Biopsychosocial Impact on Caregivers in Patients Undergoing Joint Replacement and Cervical/Thoracic/Lumbar Spine Surgery: A Pilot Study

Defense and Veterans Center for Integrative Pain Management1 site in 1 country150 target enrollmentMay 12, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Defense and Veterans Center for Integrative Pain Management
Enrollment
150
Locations
1
Primary Endpoint
Natural history of biopsychosocial impact of Caregivers
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to describe the biopsychosocial impact of caregivers in patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability to provide care following surgery on a loved one.

Detailed Description

This is a pilot feasibility study with the goal of enrolling 50 caregivers in each surgical subgroup, with a total of 150 subjects. Caregivers for patients undergoing the above surgeries will be administered Patient Reported Outcome Measurement Information System (PROMIS) measures preoperatively, 7 days postoperatively, 14 days postoperatively, and 1 month postoperatively. PROMIS item banks will include Global Health, Anxiety, Fatigue, Depression, Self Efficacy, Social Satisfaction, and Sleep Disturbance. If the caregiver reports the presence of persistent pain, Pain Interference and Physical Function will be administered.

Registry
clinicaltrials.gov
Start Date
May 12, 2016
End Date
October 30, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Defense and Veterans Center for Integrative Pain Management
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years old or older
  • Are the primary person helping in the recovery of a patient undergoing one of the following surgeries below with in the first 30 days after surgery Total knee arthroplasty Total hip arthroplasty Cervical/Thoracic/Lumbar spine surgery
  • Able to understand English and can verbalize their pain level

Exclusion Criteria

  • Younger than 18 years old
  • Refuse participation
  • Cannot understand English
  • Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)

Outcomes

Primary Outcomes

Natural history of biopsychosocial impact of Caregivers

Time Frame: 1 month

To describe the natural history of the biopsychosocial impact of Caregivers for patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spinal surgery.

Secondary Outcomes

  • Change of biopsychosocial measures over time(1 month)

Study Sites (1)

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