Trial Outcomes & Findings for Novel Text-Messaging Bot in Patients Undergoing Joint Arthroplasty (NCT NCT03388502)
NCT ID: NCT03388502
Last Updated: 2023-11-22
Results Overview
Stretching, strengthening, and other rehab-specific exercises counted toward their home-based exercises, while walking was excluded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
over a six-week time period after arthroplasty surgery
Results posted on
2023-11-22
Participant Flow
Participant milestones
| Measure |
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.
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.
|
Routine Perioperative Instructions
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
83
|
|
Overall Study
COMPLETED
|
76
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not collected.
Baseline characteristics by cohort
| Measure |
Text Messaging (SMS) Bot
n=76 Participants
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.
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.
|
Routine Perioperative Instructions
n=83 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=76 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=159 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=76 Participants
|
55 Participants
n=83 Participants
|
111 Participants
n=159 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=76 Participants
|
28 Participants
n=83 Participants
|
48 Participants
n=159 Participants
|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 8.0 • n=76 Participants
|
60.9 years
STANDARD_DEVIATION 8.2 • n=83 Participants
|
60.2 years
STANDARD_DEVIATION 8.1 • n=159 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=76 Participants
|
36 Participants
n=83 Participants
|
71 Participants
n=159 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=76 Participants
|
47 Participants
n=83 Participants
|
88 Participants
n=159 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 Participants
Data not collected.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
0 Participants
Data not collected.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
Data not collected.
|
PRIMARY outcome
Timeframe: over a six-week time period after arthroplasty surgeryStretching, strengthening, and other rehab-specific exercises counted toward their home-based exercises, while walking was excluded.
Outcome measures
| Measure |
Text Messaging (SMS) Bot
n=76 Participants
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.
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.
|
Routine Perioperative Instructions
n=83 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Time Participating in Home-Based Exercises
|
46.4 minutes
Standard Deviation 17.4
|
37.7 minutes
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: over a six-week time period after arthroplasty surgeryDegrees of flexion and extension of the operative knee will be measured at 6 weeks after surgery.
Outcome measures
| Measure |
Text Messaging (SMS) Bot
n=76 Participants
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.
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.
|
Routine Perioperative Instructions
n=83 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Knee Range of Motion
|
111.9 degrees
Standard Deviation 13.3
|
108.0 degrees
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: over a six-week time period after arthroplasty surgeryMedications 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.
Outcome measures
| Measure |
Text Messaging (SMS) Bot
n=76 Participants
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.
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.
|
Routine Perioperative Instructions
n=83 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Use of Narcotics/Opiates
|
22.5 days
Standard Deviation 13.4
|
32.4 days
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeVAS 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).
Outcome measures
| Measure |
Text Messaging (SMS) Bot
n=76 Participants
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.
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.
|
Routine Perioperative Instructions
n=83 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Visual Analog Scale (VAS) Mood Score
|
7.5 score on a scale
Standard Deviation 1.8
|
6.5 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: over a six-week time period after arthroplasty surgeryThe number of patient calls to their physicians office were tracked and recorded.
Outcome measures
| Measure |
Text Messaging (SMS) Bot
n=76 Participants
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.
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.
|
Routine Perioperative Instructions
n=83 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Calls to the Office
|
0.6 number of calls
Standard Deviation 0.8
|
2.6 number of calls
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: over a six-week time period after arthroplasty surgeryPatients were asked to fill out a satisfaction survey six weeks after surgery
Outcome measures
| Measure |
Text Messaging (SMS) Bot
n=73 Participants
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.
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.
|
Routine Perioperative Instructions
n=80 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Number of Participants Reporting Satisfaction With Instruction Clarity
|
69 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: over a six-week time period after arthroplasty surgeryThe number of visits to the ED were tracked and recorded.
Outcome measures
| Measure |
Text Messaging (SMS) Bot
n=76 Participants
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.
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.
|
Routine Perioperative Instructions
n=83 Participants
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Visits to the Emergency Department (ED)
|
0 visits
|
4 visits
|
Adverse Events
Text Messaging (SMS) Bot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Perioperative Instructions
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Text Messaging (SMS) Bot
n=76 participants at risk
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.
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.
|
Routine Perioperative Instructions
n=83 participants at risk
Patients undergoing total joint (hip \& knee) arthroplasty will receive only their 'Routine Perioperative Instructions'.
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Presentation to the Emergency Department
|
0.00%
0/76 • 6 weeks.
Does not differ.
|
4.8%
4/83 • 6 weeks.
Does not differ.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place