NCT03059602

Biopsychosocial Impact on Caregivers in Patients Undergoing Joint and Spine Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Defense and Veterans Center for Integrative Pain Management · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
OTHER	No specific treatment based intervention-health measurement instrument	Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)

Timeline

• Start date: 2016-05-12
• Primary completion: 2018-10-30
• Completion: 2018-10-30
• First posted: 2017-02-23
• Last updated: 2019-07-17

Locations

1 site across 1 country: United States