Trial Outcomes & Findings for Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop (NCT NCT03481595)
NCT ID: NCT03481595
Last Updated: 2021-11-24
Results Overview
15-item patient experience questionnaire. Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
294 participants
Primary outcome timeframe
90 days after index surgery
Results posted on
2021-11-24
Participant Flow
Participant milestones
| Measure |
Group A
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Overall Study
STARTED
|
146
|
148
|
|
Overall Study
COMPLETED
|
143
|
127
|
|
Overall Study
NOT COMPLETED
|
3
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 9 • n=143 Participants
|
65 years
STANDARD_DEVIATION 8 • n=127 Participants
|
66 years
STANDARD_DEVIATION 8 • n=270 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=143 Participants
|
67 Participants
n=127 Participants
|
148 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=143 Participants
|
60 Participants
n=127 Participants
|
122 Participants
n=270 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 90 days after index surgery15-item patient experience questionnaire. Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Percentage of Participants Reporting a Problem Across al PPE-15 Domains
|
12.6 percent of participants
Standard Deviation 15.3
|
9.5 percent of participants
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 90 days after index surgerySatisfaction measurement tool measured on a scale from 0-100 mm. Where 0 = not satisfied and 100 = entirely satisfied.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Visual Analog Scale (VAS) for Patient Satisfaction
|
91.0 units on a scale
Standard Deviation 17.3
|
91.0 units on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 90 days after index surgeryA count of the number of days the patient was admitted to the hospital after the index procedure prior to being discharged. Measured in days.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Length of Hospital Stay
|
1.4 days
Standard Deviation 0.9
|
1.2 days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 90 days after index surgeryWas the patient routinely discharged to home? Reported as yes or no.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Number of Participants Discharged to Home
|
130 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: 90 days after index surgeryA count of the number of hospital readmissions related to the index procedure within 90 days after the index procedure.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Number Participants Who Were Readmitted to the Hospital
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 90 days after index surgeryA count of the number of emergency department visits related to the index procedure within 90 days after the index procedure.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Number Participants Who Visited the Emergency Department
|
24 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 90 days after index surgeryA count of the number of outpatient follow-up visits with the surgical team related to the index procedure within 90 days after the index procedure.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Number Participants With 0, 1, 2, or 3+ Outpatient Visits
0 follow up visits
|
0 Participants
|
2 Participants
|
|
Number Participants With 0, 1, 2, or 3+ Outpatient Visits
1 follow up visit
|
21 Participants
|
17 Participants
|
|
Number Participants With 0, 1, 2, or 3+ Outpatient Visits
2 follow up visits
|
76 Participants
|
61 Participants
|
|
Number Participants With 0, 1, 2, or 3+ Outpatient Visits
3 or more follow up visits
|
46 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 90 days after index surgeryA count of the number of telephone calls with the surgical team related to the index procedure within 90 days after the index procedure.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team
0 phone encounters
|
15 Participants
|
12 Participants
|
|
Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team
1 phone encounter
|
37 Participants
|
40 Participants
|
|
Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team
2 phone encounters
|
39 Participants
|
32 Participants
|
|
Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team
3 or more phone encounters
|
52 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 90 days after index surgeryA count of the number of reoperations related to the index procedure within 90 days after the index procedure.
Outcome measures
| Measure |
Group A
n=143 Participants
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 Participants
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Number of Participants Who Had a Reoperation
|
1 Participants
|
4 Participants
|
Adverse Events
Group A
Serious events: 11 serious events
Other events: 12 other events
Deaths: 0 deaths
Group B
Serious events: 14 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group A
n=143 participants at risk
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 participants at risk
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Musculoskeletal and connective tissue disorders
Manipulation under anesthesia
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
2.4%
3/127 • Number of events 3 • 90 days following total knee or total hip arthroplasty
|
|
Endocrine disorders
Hyperkalemia
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
1.6%
2/127 • Number of events 2 • 90 days following total knee or total hip arthroplasty
|
|
Renal and urinary disorders
Urinary retention
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Respiratory, thoracic and mediastinal disorders
Effusions
|
0.00%
0/143 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/143 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/143 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Infections and infestations
Cellulitis
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Nervous system disorders
Seizure
|
0.00%
0/143 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Immune system disorders
Allergy
|
0.00%
0/143 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Nervous system disorders
Transverse myelitis
|
0.00%
0/143 • 90 days following total knee or total hip arthroplasty
|
0.79%
1/127 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
|
Renal and urinary disorders
Urinary tract infection
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.00%
0/127 • 90 days following total knee or total hip arthroplasty
|
|
Gastrointestinal disorders
GI distress
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.00%
0/127 • 90 days following total knee or total hip arthroplasty
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.00%
0/127 • 90 days following total knee or total hip arthroplasty
|
|
Infections and infestations
Suture abscess
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.00%
0/127 • 90 days following total knee or total hip arthroplasty
|
|
Infections and infestations
Sepsis
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.00%
0/127 • 90 days following total knee or total hip arthroplasty
|
|
Nervous system disorders
Hiccups (hospitalized)
|
0.70%
1/143 • Number of events 1 • 90 days following total knee or total hip arthroplasty
|
0.00%
0/127 • 90 days following total knee or total hip arthroplasty
|
Other adverse events
| Measure |
Group A
n=143 participants at risk
Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
|
Group B
n=127 participants at risk
Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.
HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
|
|---|---|---|
|
General disorders
swelling
|
1.4%
2/143 • Number of events 2 • 90 days following total knee or total hip arthroplasty
|
2.4%
3/127 • Number of events 3 • 90 days following total knee or total hip arthroplasty
|
|
General disorders
hypotension
|
2.8%
4/143 • Number of events 4 • 90 days following total knee or total hip arthroplasty
|
3.1%
4/127 • Number of events 4 • 90 days following total knee or total hip arthroplasty
|
|
Renal and urinary disorders
UTI
|
2.1%
3/143 • Number of events 3 • 90 days following total knee or total hip arthroplasty
|
2.4%
3/127 • Number of events 3 • 90 days following total knee or total hip arthroplasty
|
|
General disorders
nausea
|
2.1%
3/143 • Number of events 3 • 90 days following total knee or total hip arthroplasty
|
0.00%
0/127 • 90 days following total knee or total hip arthroplasty
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place