NCT03059602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

February 16, 2017

Last Update Submit

July 16, 2019

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Natural history of biopsychosocial impact of Caregivers

    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.

    1 month

Secondary Outcomes (1)

  • Change of biopsychosocial measures over time

    1 month

Study Arms (3)

Knee group

Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing total knee arthroplasty.

Other: No specific treatment based intervention-health measurement instrument

Hip group

Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing total hip arthroplasty.

Other: No specific treatment based intervention-health measurement instrument

Spine group

Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing Cervical/Thoracic Lumbar Spine Surgery (Discectomy, Foraminotomy, Laminectomy, Fusion, Nerve Root Decompression)

Other: No specific treatment based intervention-health measurement instrument

Interventions

No specific treatment based intervention-health measurement instrumentOTHER

Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)

Hip groupKnee groupSpine group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Caregivers of male and female military health care beneficiaries age 18 years and older presenting for total knee arthroplasty, total hip arthroplasty, and Cervical/Thoracic/Lumbar spine surgery. Caregivers are defined as individuals who will be the primary source of assistance (medical, rehabilitative, daily living, etc) within the first 30 days after surgery.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

May 12, 2016

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)