Understanding Caregiver Burden for Hip and Knee Replacement Surgery Patients

NCT04838197 | Completed

• 1 other identifier: 2021-0045-E
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Caregiver burden is the response to the emotional, financial, physical, psychological, and social stressors associated with having to care for another family member. Previous studies have looked at the impact of caregiver burden in caregivers caring for loved ones dealing with long-term disease, such as dementia. The research has found that one in three caregivers suffer from depression, and experience high levels of stress and anxiety. However, these findings may not be relatable to the outpatient surgical setting. The purpose of this study is to find out how various factors such as the physical, emotional, social, and financial burden impact caregivers who are responsible for providing care to patients who are undergoing same-day surgical procedures that are traditionally performed as inpatient surgery. By understanding this potential burden on the caregiver, we hope that future healthcare improvements can be made to minimize this impact on the patients and their caregiver.

Conditions

Caregiver Burnout

Keywords

Total Joint surgeries; Total Knee Arthoplasty; Total Hip Arthoplasty

Outcome Measures

Primary Outcomes (1)

• Care-giver experience assessment with homegrown quantitative questionnaires

  To gain an understanding of the various factors contributing to the burden of care experienced in the post-operative setting among our caregivers caring for patients undergoing TKA or THA within our ambulatory model. (e.g., intensity of dependence, duration of care, health literacy, physical well-being, emotional well-being, social well-being, and financial well-being) On a scale of 5-Point Likert Scale from Strongly Disagree to Strongly Agree

  before surgery up to discharge, assessed up to 1 month

Secondary Outcomes (13)

• Intensity of patient dependence on the caregiver

  at 48 hours, 1 week, 2 weeks, and 1 month post-operatively

• Time expected to care for the patient

  at 48 hours, 1 week, 2 weeks, and 1 month post-operatively

• Number of people the caregiving responsibilities have been shared with

  at 48 hours, 1 week, 2 weeks, and 1 month post-operatively

• Caregivers' preparedness

  at 48 hours, 1 week, 2 weeks, and 1 month post-operatively

• Caregivers' reliance on additional medical information to help assist in care-giving

  at 48 hours, 1 week, 2 weeks, and 1 month post-operatively

Study Arms (1)

Caregiver

If the caregiver agrees and consents to participating in the study, basic demographic and social data will be collected at baseline. The caregiver will also complete the caregiver burden questionnaire via telephone call at five different time points: pre-operatively, and post-operative 48 hours, 1 week, 2 weeks, and 1 month.

Other: Questionnaires and Surveys

Interventions

Questionnaires and Surveys OTHER

Quantitative questionnaires will measure and quantify the importance of the various factors (e.g., intensity of dependence, duration of care, health literacy, physical well-being, emotional well-being, social well-being, and financial well-being) that contribute to caregiver burden both preoperatively and postoperatively at 48 hours, 1 week, 2 weeks, and 1 month.

Caregiver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing ambulatory TKA or THA will be approached for consent. Their primary caregivers will be consented to participate as well.

You may qualify if:

• Undergoing ambulatory total knee or total hip arthroplasty
• Patient is able to consent for self
• English speaking, or willing to use an interpreter
• Over the age of 18 years
• Primarily responsible for providing care to the patient undergoing ambulatory total knee or total hip arthroplasty

You may not qualify if:

• Refusal or unable to provide informed consent
• The patient is a resident in a nursing home or is already receiving daily professional care for most ADLs
• Unable to complete data collection tools or take part in telephone interviews due to cognitive or physical impairment
• Withdrawal Criteria After Enrollment
• Patient or Caregiver refusal to participate or continue with the study at any point
• Cancellation of surgery

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Caregiver Burden

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Richard Brull, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 9, 2021
• Study Start: March 3, 2022
• Primary Completion: October 28, 2023
• Study Completion: October 31, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)