Post-Op ComplicationNCT04586296
Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study
A study testing Telemedicine in people with Post-Op Complication, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to develop an effective telephone mediated follow-up system to reduce the number of unplanned readmissions and emergency department visits after total joint arthroplasty. This will help reduce costs related to unnecessary visits to the hospital as well as catch complications earlier on. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 16 Aug 2023
- Phase
- Interventional
- 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
Who may be able to join
- Participants eligible to undergo the TJA surgical procedure
Who cannot join
- Participants who are not eligible to undergo the TJA surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop an effective telephone mediated follow-up system to reduce the number of unplanned readmissions and emergency department visits after total joint arthroplasty. This will help reduce costs related to unnecessary visits to the hospital as well as catch complications earlier on. The investigators plan to accomplish this by performing a pilot study that will compare the outcomes of using an Interactive Voice Response system through phone call in addition to the standard follow-up protocol. The outcomes of this group will be compared to those receiving the standard of care follow-up protocol.
Read the detailed description
Upon patient education and consent to participate in this study, patients will be randomized via online randomizer during their baseline visit into either Treatment As Usual (TAU) or Integrated Voice Response (IVR) cohorts. During this baseline visit, the patients in the IVR group will be given specific information on the nature of the calls and what to expect. Both groups will fill out a form for assessing their baseline pain and functionality. Both groups will receive standard total joint arthroplasty. After this, the TAU group will receive the standard of care which involves appropriate pain management and scheduled clinic follow-ups lasting approximately 60 minutes at 2 weeks, 6 weeks, and 12 weeks along with additional visits if required. Clinic visits will assess pain via VAS scale, joint functionality via HOOS and KOOS scale, and quality of life via SF-36.
In addition to the standard of care follow-up visits as in the TAU group, the IVR group will also receive automated phone calls lasting up to 3 minutes, which will be the focus of this research study. These phone calls will be daily for the first week, every other day the second week, twice a week for weeks 3-6, and weekly for weeks 7-12. The content of these calls will assess pain management, wound healing and screen for potential complications through a series of questions (questionnaire script attached). At the completion of each call, the patient will be instructed to either continue standard treatment or visit the emergency department based on the content of their response. If there is reason for concern, the PI will automatically be informed.
Survey questions pertaining to the patients outcomes and satisfaction will be completed in clinic and collected by the PI. The responses and data relating to IVR calls will made available through computer software designed by our team on the secure REDcap network.
- Conditions
- Post-Op Complication
- Being tested
- Telemedicine
- Keywords
- telemedicine, knee replacement, hip replacement
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Also called Integrated Voice Response (IVR)
IVR will consist of a 3 minute call at a decreasing interval from the time of surgery. Questions will assess pain control, signs of infection, prosthesis failure.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Group | Experimental | Group that will be receiving the telemedicine intervention in addition to the standard of care post-op. Receives: Other: Telemedicine |
| Standard Treatment | No intervention | Patients will be receiving the standard of care, post op visits at 2, 6, and 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Measured: 2 week
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Measured: 6 weeks
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Measured: 12 weeks
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Measured: Baseline
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
HOOS is patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Measured: Baseline
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS) and knee disability and osteoarthritis outcome score (KOOS)
KOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Measured: Baseline
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Measured: 2 weeks
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
HOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Measured: 2 weeks
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
HOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Measured: 6 weeks
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Measured: 6 weeks
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
HOOS is a patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Measured: 12 weeks
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
KOOS is a patient measured score evaluating Hip and knee function and creates a score out of 100, 100 indicating full functionality.
Measured: 12 weeks
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Baseline
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 2 weeks
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 6 weeks
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start16 Mar 2021
- Primary completion15 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameer Naranje, University of Alabama at Birmingham
- Investigators
- Sameer Naranje, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586296
- Sponsor's protocol ID
- IRB-300005894
- Status last verified
- Aug 2023
- First submitted
- 6 Oct 2020
- Last updated
- 16 Aug 2023
- 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04586296
- Acronym / sponsor ID
- IRB-300005894
- Conditions
- Post-Op Complication
- Keywords
- telemedicine, knee replacement, hip replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 14 Oct 2020 (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.
The purpose of this study is to develop an effective telephone mediated follow-up system to reduce the number of unplanned readmissions and emergency department visits after total joint arthroplasty. This will help reduce costs related to unnecessary visits to the hospital as well as catch complications earlier on. The investigators plan to accomplish this by performing a pilot study that will compare the outcomes of using an Interactive Voice Response system through phone call in addition to the standard follow-up protocol. The outcomes of this group will be compared to those receiving the standard of care follow-up protocol.
Detailed description
Upon patient education and consent to participate in this study, patients will be randomized via online randomizer during their baseline visit into either Treatment As Usual (TAU) or Integrated Voice Response (IVR) cohorts. During this baseline visit, the patients in the IVR group will be given specific information on the nature of the calls and what to expect. Both groups will fill out a form for assessing their baseline pain and functionality. Both groups will receive standard total joint arthroplasty. After this, the TAU group will receive the standard of care which involves appropriate pain management and scheduled clinic follow-ups lasting approximately 60 minutes at 2 weeks, 6 weeks, and 12 weeks along with additional visits if required. Clinic visits will assess pain via VAS scale, joint functionality via HOOS and KOOS scale, and quality of life via SF-36.
In addition to the standard of care follow-up visits as in the TAU group, the IVR group will also receive automated phone calls lasting up to 3 minutes, which will be the focus of this research study. These phone calls will be daily for the first week, every other day the second week, twice a week for weeks 3-6, and weekly for weeks 7-12. The content of these calls will assess pain management, wound healing and screen for potential complications through a series of questions (questionnaire script attached). At the completion of each call, the patient will be instructed to either continue standard treatment or visit the emergency department based on the content of their response. If there is reason for concern, the PI will automatically be informed.
Survey questions pertaining to the patients outcomes and satisfaction will be completed in clinic and collected by the PI. The responses and data relating to IVR calls will made available through computer software designed by our team on the secure REDcap network.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Group | Experimental | Other: TelemedicineGroup that will be receiving the telemedicine intervention in addition to the standard of care post-op. |
| Standard Treatment | No intervention | –Patients will be receiving the standard of care, post op visits at 2, 6, and 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants eligible to undergo the TJA surgical procedure
Key exclusion criteria (1 listed)
- Participants who are not eligible to undergo the TJA surgical procedure
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 |
|---|---|---|
| TelemedicineAlso: Integrated Voice Response (IVR)IVR will consist of a 3 minute call at a decreasing interval from the time of surgery. Questions will assess pain control, signs of infection, prosthesis failure. | Other | Telemedicine Group |
Primary outcome
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Time frame: 2 week
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Time frame: 6 weeks
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Time frame: 12 weeks
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Time frame: Baseline
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Time frame: Baseline
HOOS is patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS) and knee disability and osteoarthritis outcome score (KOOS)
Time frame: Baseline
KOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Time frame: 2 weeks
KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Time frame: 2 weeks
HOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Time frame: 6 weeks
HOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Time frame: 6 weeks
KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Time frame: 12 weeks
HOOS is a patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Time frame: 12 weeks
KOOS is a patient measured score evaluating Hip and knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Time frame: Baseline
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Time frame: 2 weeks
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Time frame: 6 weeks
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Time frame: 12 weeks
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
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 16 Aug 2023.
- 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.
Sameer Naranje, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Post-Op Complication, run by University of Alabama at Birmingham at 1 site in United States.
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 1 inclusion and 1 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 16 Aug 2023. 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 United States. 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?
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale (time frame: 2 week). The study lists 16 primary outcomes in all. 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 16 Aug 2023.