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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03059602
Enrollment
150
Registered
2017-02-23
Start date
2016-05-12
Completion date
2018-10-30
Last updated
2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

OTHERNo 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)

Sponsors

Defense and Veterans Center for Integrative Pain Management
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Natural history of biopsychosocial impact of Caregivers1 monthTo 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

MeasureTime frameDescription
Change of biopsychosocial measures over time1 monthTo assess the biopsychosocial measure over time from the following time points: Preoperative, 7 days, 14 days postoperatively, and 1 month postoperatively.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026