- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03388502
Novel Text-Messaging Bot in Patients Undergoing Joint Arthroplasty
Effectiveness of a Novel Text-Messaging Bot in Patients Undergoing Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
In an era of value-based reimbursement and high-volume surgery, the patient experience is becoming increasingly important. Despite publicized efforts to place a greater emphasis on patient-centered care, patients often report poor access to their physician, lack of effective perioperative education, and frustration as their care is commoditized.
A text-messaging (SMS) bot has the potential to help fill some of these voids. Bots are computer programs that are inherently automated to simulate human-like tasks. While a physician may wish he or she could contact each of their patients daily, it would be an impossible undertaking for most. An SMS bot could make daily contact possible by automating it, potentially improving patient education and engagement before and after surgery. Standard SMS has been previously reported to be an effective means for delivering timely information, increasing patient compliance and outcomes (medication adherence, decrease surgical infections with antiseptic showers), and reaching a socioeconomically diverse patient population. Further benefits may be seen with an SMS bot due to its automated capabilities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion criteria consisted of patients over 18 years of age, scheduled for primary total hip & knee arthroplasty, with smart phone capability, and proficiency in English.
Exclusion Criteria:
- Patients less than 18 years of age, no smart phone capability, poor English proficiency.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Text Messaging (SMS) Bot
Patients undergoing total joint (hip & knee) arthroplasty will be enrolled in their physician's automated 'Text Messaging (SMS) Bot' in addition to receiving the routine perioperative education and instructions.
|
Patients will be enrolled in an 'Automated Text Messaging (SMS) Bot (intervention group)' which is a computer program that sends patients timely reminders, instructions, and videos to help them prepare and recover from surgery.
|
|
Active Comparator: Routine Perioperative Instructions
Patients undergoing total joint (hip & knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
|
Patients will receive the 'Routine perioperative education & teaching (control group)' and will not be enrolled in the physician-specific SMS bot.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Participating in Home-Based Exercises
Time Frame: over a six-week time period after arthroplasty surgery
|
Stretching, strengthening, and other rehab-specific exercises counted toward their home-based exercises, while walking was excluded.
|
over a six-week time period after arthroplasty surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of Narcotics/Opiates
Time Frame: over a six-week time period after arthroplasty surgery
|
Medications designated as "narcotics" included any medications that contained: hydrocodone, oxycodone, codeine, morphine, or tramadol.
Patients were instructed to record their responses during the same two-hour window each day in a daily diary.
|
over a six-week time period after arthroplasty surgery
|
|
Calls to the Office
Time Frame: over a six-week time period after arthroplasty surgery
|
The number of patient calls to their physicians office were tracked and recorded.
|
over a six-week time period after arthroplasty surgery
|
|
Visits to the Emergency Department (ED)
Time Frame: over a six-week time period after arthroplasty surgery
|
The number of visits to the ED were tracked and recorded.
|
over a six-week time period after arthroplasty surgery
|
|
Knee Range of Motion
Time Frame: over a six-week time period after arthroplasty surgery
|
Degrees of flexion and extension of the operative knee will be measured at 6 weeks after surgery.
|
over a six-week time period after arthroplasty surgery
|
|
Visual Analog Scale (VAS) Mood Score
Time Frame: 6 weeks post-operative
|
VAS mood scores were collected from patients on the standard ten-point validated scale.
If a patient circled two adjacent numbers on their daily diary, an average of the two numbers were assigned for that day.
Minimum score 0. Maximum score 10.
Higher score is worse outcome (more pain).
|
6 weeks post-operative
|
|
Number of Participants Reporting Satisfaction With Instruction Clarity
Time Frame: over a six-week time period after arthroplasty surgery
|
Patients were asked to fill out a satisfaction survey six weeks after surgery
|
over a six-week time period after arthroplasty surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kevin J Campbell, MD, Rush University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16050101-IRB02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Knee
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
-
University of MiamiNot yet recruiting
-
Kutahya Health Sciences UniversityActive, not recruitingKnee Osteoarthritis | Knee DiseaseTurkey (Türkiye)
Clinical Trials on Automated Text Messaging (SMS) Bot (intervention group)
-
Harvard Medical School (HMS and HSDM)Partners in HealthActive, not recruitingCOVID-19 | Mental Health | MisinformationHaiti, Malawi, Rwanda
-
Centre for Addiction and Mental HealthCompletedPsychotic DisordersCanada
-
Stanford UniversityTerminatedReminder Systems | Urinary Dysfunction | Text Messaging | Urinary Bladder | Behavior Change TechniquesUnited States
-
Black Hills State UniversityCompleted
-
Liverpool School of Tropical MedicineNational Institute for Medical Research, Tanzania; Ministry of Health and Social...UnknownPregnancy | HIV | Contraception | Sexually Transmitted InfectionsTanzania
-
Duke UniversityCompletedA Diagnosis of Any Hematologic or Solid MalignancyUnited States
-
Northwestern UniversityIcahn School of Medicine at Mount Sinai; Emory University; Northwestern Memorial...CompletedDiabetes Mellitus, Type 2 | Medication AdherenceUnited States
-
University of WashingtonUniversity of California, San Francisco; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency SyndromeKenya
-
University of WashingtonUniversity of Illinois at Chicago; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency Syndrome | Circumcision, Male | Patient Compliance | Cellular PhoneKenya
-
Memorial Sloan Kettering Cancer CenterCompletedSarcoma | Lung | Solid Tumor GastrointestinalUnited States