Osteoarthritis, KneeNCT03388502
Novel Text-Messaging Bot in Patients Undergoing Joint Arthroplasty
A study testing Automated Text Messaging (SMS) Bot (intervention group) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Rush University Medical Center.
Trial summary
This study evaluates the addition of an automated physician-specific text-messaging (SMS) bot in patients undergoing total joint arthroplasty. Half of the patients received the traditional perioperative education and instructions (control group), while the other half were enrolled in their physician's SMS bot… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Automated Text Messaging (SMS) Bot (intervention group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2016to 1 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
Who cannot join
- Patients less than 18 years of age, no smart phone capability, poor English proficiency.
About this study
Official title: Effectiveness of a Novel Text-Messaging Bot in Patients Undergoing Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
This study evaluates the addition of an automated physician-specific text-messaging (SMS) bot in patients undergoing total joint arthroplasty. Half of the patients received the traditional perioperative education and instructions (control group), while the other half were enrolled in their physician's SMS bot (intervention group).
Read the 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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Automated Text Messaging (SMS) Bot (intervention group), Routine perioperative education & teaching (control group)
- Keywords
- Total knee arthroplasty, Total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Text Messaging (SMS) Bot (intervention group)Other
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.
Routine perioperative education & teaching (control group)Other
Patients will receive the 'Routine perioperative education \& teaching (control group)' and will not be enrolled in the physician-specific SMS bot.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging (SMS) Bot | Experimental | 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. Receives: Other: Automated Text Messaging (SMS) Bot (intervention group) |
| Routine Perioperative Instructions | Active comparator | Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'. Receives: Other: Routine perioperative education & teaching (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Participating in Home-Based Exercises
Stretching, strengthening, and other rehab-specific exercises counted toward their home-based exercises, while walking was excluded.
Measured: over a six-week time period after arthroplasty surgery
Secondary outcomes (6)
Knee Range of Motion
Degrees of flexion and extension of the operative knee will be measured at 6 weeks after surgery.
Measured: over a six-week time period after arthroplasty surgery
Use of Narcotics/Opiates
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.
Measured: over a six-week time period after arthroplasty surgery
Visual Analog Scale (VAS) Mood Score
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).
Measured: 6 weeks post-operative
Calls to the Office
The number of patient calls to their physicians office were tracked and recorded.
Measured: over a six-week time period after arthroplasty surgery
Number of Participants Reporting Satisfaction With Instruction Clarity
Patients were asked to fill out a satisfaction survey six weeks after surgery
Measured: over a six-week time period after arthroplasty surgery
Visits to the Emergency Department (ED)
The number of visits to the ED were tracked and recorded.
Measured: over a six-week time period after arthroplasty surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start21 Nov 2016
- Primary completion1 Aug 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin J Campbell, MD, Study director, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388502
- Sponsor's protocol ID
- 16050101-IRB02
- Status last verified
- Feb 2023
- First submitted
- 24 Dec 2017
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Text-Messaging Bot in Patients Undergoing Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03388502
- Acronym / sponsor ID
- 16050101-IRB02
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Total knee arthroplasty, Total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Posted 22 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the addition of an automated physician-specific text-messaging (SMS) bot in patients undergoing total joint arthroplasty. Half of the patients received the traditional perioperative education and instructions (control group), while the other half were enrolled in their physician's SMS bot (intervention group).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messaging (SMS) Bot | Experimental | Other: Automated Text Messaging (SMS) Bot (intervention group)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. |
| Routine Perioperative Instructions | Active comparator | Other: Routine perioperative education & teaching (control group)Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients less than 18 years of age, no smart phone capability, poor English proficiency.
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 |
|---|---|---|
| Automated Text Messaging (SMS) Bot (intervention group)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. | Other | Text Messaging (SMS) Bot |
| Routine perioperative education & teaching (control group)Patients will receive the 'Routine perioperative education \& teaching (control group)' and will not be enrolled in the physician-specific SMS bot. | Other | Routine Perioperative Instructions |
Primary outcome
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.
6 secondary outcomes
Knee Range of Motion
Time frame: over a six-week time period after arthroplasty surgery
Use of Narcotics/Opiates
Time frame: over a six-week time period after arthroplasty surgery
Visual Analog Scale (VAS) Mood Score
Time frame: 6 weeks post-operative
Calls to the Office
Time frame: over a six-week time period after arthroplasty surgery
Number of Participants Reporting Satisfaction With Instruction Clarity
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
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.
Kevin J Campbell, MD study director
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Automated Text Messaging (SMS) Bot (intervention group) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Rush University Medical Center.
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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Participating in Home-Based Exercises (time frame: over a six-week time period after arthroplasty surgery). 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 22 Nov 2023.