Caregiver BurnoutNCT04838197
Understanding Caregiver Burden for Hip and Knee Replacement Surgery Patients
An observational study of Caregiver Burnout, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burnout
- What is being tested?
- Questionnaires and Surveys
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 3 Mar 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing ambulatory TKA or THA will be approached for consent. Their primary caregivers will be consented to participate as well.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Caregiver Burden When Traditional Total Hip and Knee Replacement Surgeries Shift From Inpatient Hospitalization to Outpatient Settings: A Prospective Cohort Study
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.
Read the detailed description
The extent of caregiver burden in the acute postoperative outpatient settings, immediately following major orthopedic surgery that has traditionally been performed in an inpatient setting, remains unknown. Care giving places a tremendous amount of physical and mental stress onto the caregiver, which may result in the "hidden patient" in the caregiver. It is expected that by 2026, 51% of TJA will be performed as outpatient procedures. Building on the successes of the country's first outpatient TKA program at Women's College Hospital, and with the expansion to include outpatient THA procedures, it is now important to understand whether or not our innovative ambulatory model is simply transferring the burden of postoperative care and recovery from nurses, doctors, and other hospital staff to family members, friends, or privately-employed caregivers.
In the current state of literature, there is inadequate data examining caregiver burden when traditional surgical procedures are shifted to an outpatient setting, therefore, a comprehensive study is required to understand the various dimensions of caregiver burden. Therefore, our research question is "what are the most important factors that contribute to the burden of care for caregivers of patients undergoing outpatient surgical procedures traditionally performed as inpatients?"
This prospective cohort study examines how the various dimensions of caregiver burden impact caregivers at different time points throughout the care giving experience. These dimensions include factors such as the intensity of dependence on the caregiver, duration of care, caregiver specific factors (e.g., the health literacy of the caregiver), and care giving dimensions (e.g., physical, emotional, social and financial burdens). Through gaining an understanding of how the various dimensions of caregiver burden impact caregivers in the outpatient settings, meaningful improvements can be made in the future and ultimately improve the quality of life of the caregiver during the time of care.
- Conditions
- Caregiver Burnout
- Being tested
- Questionnaires and Surveys
- Keywords
- Total Joint surgeries, Total Knee Arthoplasty, Total Hip Arthoplasty
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and SurveysOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires and Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before surgery up to discharge, assessed up to 1 month
Secondary outcomes (13)
Intensity of patient dependence on the caregiver
Using the Katz Index of Independence in Activities of Daily Living
Measured: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Time expected to care for the patient
This section will ask caregivers about the number of hours they spend/expect to spend performing caregiving activities.
Measured: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Number of people the caregiving responsibilities have been shared with
This section will ask caregivers questions focusing on their health literacy, defined as "the ability to obtain, read, understand and use healthcare information". Caregivers will be asked how prepared/confident they feel performing the necessary medical caregiving tasks, and if they have sought out additional medical information from healthcare professionals, or online resources to help assist in a caregiving task. Finally, caregivers will be asked to identify if they have shared the caregiving responsibilities with another person throughout the caregiving experience
Measured: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Caregivers' preparedness
This section will ask caregivers questions focusing on their health literacy, defined as "the ability to obtain, read, understand and use healthcare information". Caregivers will be asked how prepared/confident they feel performing the necessary medical caregiving tasks, and if they have sought out additional medical information from healthcare professionals, or online resources to help assist in a caregiving task. Finally, caregivers will be asked to identify if they have shared the caregiving responsibilities with another person throughout the caregiving experience
Measured: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Caregivers' reliance on additional medical information to help assist in care-giving
This section will ask caregivers questions focusing on their health literacy, defined as "the ability to obtain, read, understand and use healthcare information". Caregivers will be asked how prepared/confident they feel performing the necessary medical caregiving tasks, and if they have sought out additional medical information from healthcare professionals, or online resources to help assist in a caregiving task. Finally, caregivers will be asked to identify if they have shared the caregiving responsibilities with another person throughout the caregiving experience
Measured: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Caregivers' perceptions on the physical demands of caregiving
This section will ask caregivers questions regarding the impact of caregiving on their physical well-being. Caregivers will be asked pre-operatively if they expect caring for the patient will be physically demanding, and post-operatively if caring for the patient has been physically demanding. As well, caregivers will be asked if preparing for/caring for the patient has disrupted their sleep
Measured: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Disruption to the caregivers sleep
This section will ask caregivers questions regarding the impact of caregiving on their physical well-being. Caregivers will be asked pre-operatively if they expect caring for the patient will be physically demanding, and post-operatively if caring for the patient has been physically demanding. As well, caregivers will be asked if preparing for/caring for the patient has disrupted their sleep
Measured: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Presence of depression and anxiety within caregivers
To further measure anxiety and depression, caregivers will complete the Hospital Anxiety and Depression Scale (HADS). HADS was designed to be a reliable, valid, and simple to use tool to identify and quantify anxiety and depression. Though the term 'hospital' in the title suggests it only valid in the hospital setting, many studies have confirmed the tools valid use in primary care medical and community settings. HADS is comprised of 14 items, 7 assessing anxiety and 7 assessing depression.
Measured: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Disruption to the caregivers' emotional well-being
This section will ask caregivers questions regarding the impact of caregiving on their emotional well-being. Caregivers will be asked if preparing for/caring for the patient has disrupted their emotional well-being (e.g., anxious, depressed, irritable, angry, etc.).Each item is rated on a 4-point scale ranging from 0 meaning no not at all, to 3 meaning yes definitely. The total score for each sub scale ranges from 0-21, where 0-7 indicates non-cases, 8-10 indicates mild cases, 11-14 indicates moderate cases, and 15-21 indicates cases of anxiety or depression.
Measured: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Disruption to the caregivers' social well-being
This section will ask caregivers questions regarding the impact of caregiving on their social well-being. Caregivers will be asked if preparing for/caring for the patient has disrupted their social well-being (e.g., socializing with friends and family, participating in recreational/leisure activities, etc.).
Measured: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Presence of financial strain due to caregiving
This section will ask caregivers questions regarding the impact of caregiving on their financial health. Caregivers will be asked if preparing for/caring for the patient has caused financial strain. Caregivers will be asked to identify how many days they expect to take off work to care for the patient, and how many days they actually took off work to care for the patient. Likewise, caregivers will be asked how much out of pocket they expect to spend on the patient during the caregiving experience, and then on post-operative 1 month they will be asked how much they actually spent on the patient during the caregiving experience.
Measured: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Number of days expected to be taken off work to help care for the patient
This section will ask caregivers questions regarding the impact of caregiving on their financial health. Caregivers will be asked if preparing for/caring for the patient has caused financial strain. Caregivers will be asked to identify how many days they expect to take off work to care for the patient, and how many days they actually took off work to care for the patient. Likewise, caregivers will be asked how much out of pocket they expect to spend on the patient during the caregiving experience, and then on post-operative 1 month they will be asked how much they actually spent on the patient during the caregiving experience.
Measured: pre-operatively, and the actual number of days taken off to help care for the patient at 1 month
Amount expected to be spent throughout the caregiving experience
This section will ask caregivers to identify which factors are contributing the greatest to caregiver burden at various time points throughout the caregiving experience. Caregivers will be asked: "If you were given $1,000 to spend immediately to help ease the caregiving experience, how would you allocate your spending on the following factors?" Caregivers will be able to allocate the money among the seven factors previously mentioned, with hopes that caregivers will be allocating the money to different factors that are contributing significantly to the caregiver burden at various time points.
Measured: pre-operatively, and the amount spent during the caregiving experience at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start3 Mar 2022
- Primary completion28 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838197
- Sponsor's protocol ID
- 2021-0045-E
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Caregiver Burden When Traditional Total Hip and Knee Replacement Surgeries Shift From Inpatient Hospitalization to Outpatient Settings: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04838197
- Acronym / sponsor ID
- 2021-0045-E
- Conditions
- Caregiver Burnout
- Keywords
- Total Joint surgeries, Total Knee Arthoplasty, Total Hip Arthoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The extent of caregiver burden in the acute postoperative outpatient settings, immediately following major orthopedic surgery that has traditionally been performed in an inpatient setting, remains unknown. Care giving places a tremendous amount of physical and mental stress onto the caregiver, which may result in the "hidden patient" in the caregiver. It is expected that by 2026, 51% of TJA will be performed as outpatient procedures. Building on the successes of the country's first outpatient TKA program at Women's College Hospital, and with the expansion to include outpatient THA procedures, it is now important to understand whether or not our innovative ambulatory model is simply transferring the burden of postoperative care and recovery from nurses, doctors, and other hospital staff to family members, friends, or privately-employed caregivers.
In the current state of literature, there is inadequate data examining caregiver burden when traditional surgical procedures are shifted to an outpatient setting, therefore, a comprehensive study is required to understand the various dimensions of caregiver burden. Therefore, our research question is "what are the most important factors that contribute to the burden of care for caregivers of patients undergoing outpatient surgical procedures traditionally performed as inpatients?"
This prospective cohort study examines how the various dimensions of caregiver burden impact caregivers at different time points throughout the care giving experience. These dimensions include factors such as the intensity of dependence on the caregiver, duration of care, caregiver specific factors (e.g., the health literacy of the caregiver), and care giving dimensions (e.g., physical, emotional, social and financial burdens). Through gaining an understanding of how the various dimensions of caregiver burden impact caregivers in the outpatient settings, meaningful improvements can be made in the future and ultimately improve the quality of life of the caregiver during the time of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver | – | Other: Questionnaires and SurveysIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ambulatory TKA or THA will be approached for consent. Their primary caregivers will be consented to participate as well.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and SurveysQuantitative 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. | Other | Caregiver |
Primary outcome
Care-giver experience assessment with homegrown quantitative questionnaires
Time frame: before surgery up to discharge, assessed up to 1 month
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
13 secondary outcomes
Intensity of patient dependence on the caregiver
Time frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Time expected to care for the patient
Time frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Number of people the caregiving responsibilities have been shared with
Time frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Caregivers' preparedness
Time frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Caregivers' reliance on additional medical information to help assist in care-giving
Time frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Caregivers' perceptions on the physical demands of caregiving
Time frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Disruption to the caregivers sleep
Time frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Presence of depression and anxiety within caregivers
Time frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Disruption to the caregivers' emotional well-being
Time frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Disruption to the caregivers' social well-being
Time frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Presence of financial strain due to caregiving
Time frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Number of days expected to be taken off work to help care for the patient
Time frame: pre-operatively, and the actual number of days taken off to help care for the patient at 1 month
Amount expected to be spent throughout the caregiving experience
Time frame: pre-operatively, and the amount spent during the caregiving experience at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brull, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Burnout, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care-giver experience assessment with homegrown quantitative questionnaires (time frame: before surgery up to discharge, assessed up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.