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Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study

Primary Purpose

Post-Op Complication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-Op Complication focused on measuring telemedicine, knee replacement, hip replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants eligible to undergo the TJA surgical procedure

Exclusion Criteria:

  • Participants who are not eligible to undergo the TJA surgical procedure

Sites / Locations

  • UAB Highland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine Group

Standard Treatment

Arm Description

Group that will be receiving the telemedicine intervention in addition to the standard of care post-op.

Patients will be receiving the standard of care, post op visits at 2, 6, and 12 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
August 15, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04586296
Brief Title
Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study
Official Title
Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication
Keywords
telemedicine, knee replacement, hip replacement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Group
Arm Type
Experimental
Arm Description
Group that will be receiving the telemedicine intervention in addition to the standard of care post-op.
Arm Title
Standard Treatment
Arm Type
No Intervention
Arm Description
Patients will be receiving the standard of care, post op visits at 2, 6, and 12 weeks.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Other Intervention Name(s)
Integrated Voice Response (IVR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Description
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Time Frame
2 week
Title
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Description
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Time Frame
6 weeks
Title
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Description
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Time Frame
12 weeks
Title
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Description
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Time Frame
Baseline
Title
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Description
HOOS is patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Time Frame
Baseline
Title
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)
Description
KOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Time Frame
Baseline
Title
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Description
KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Time Frame
2 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Description
HOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Time Frame
2 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Description
HOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Time Frame
6 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Description
KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.
Time Frame
6 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
Description
HOOS is a patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Time Frame
12 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Description
KOOS is a patient measured score evaluating Hip and knee function and creates a score out of 100, 100 indicating full functionality.
Time Frame
12 weeks
Title
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Description
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.
Time Frame
Baseline
Title
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Description
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.
Time Frame
2 weeks
Title
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Description
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.
Time Frame
6 weeks
Title
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants eligible to undergo the TJA surgical procedure Exclusion Criteria: Participants who are not eligible to undergo the TJA surgical procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameer Naranje, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Highland Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study

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