NCT04838197|Completed
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Sponsor study identifier
observational
25
1 country
1
Study Start
March 3, 2022
Actual (reported)Primary Completion
October 28, 2023
Actual (reported)Study Completion
October 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2021
Actual (reported)April 9, 2021
Actual (reported)March 3, 2022
Actual (reported)October 28, 2023
Actual (reported)October 31, 2023
Actual (reported)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
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients undergoing ambulatory TKA or THA will be approached for consent. Their primary caregivers will be consented to participate as well.
Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
Richard Brull, MD
Women's College Hospital
25 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2021
First Posted
April 9, 2021
Study Start
March 3, 2022
Actual (reported)Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
Contact the study team to confirm eligibility.
Primary Completion
October 28, 2023
Actual (reported)Study Completion
October 31, 2023
Actual (reported)Last Updated
April 23, 2024
Record last verified: 2024-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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