Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop

NCT03481595 | Completed Results FDA Device

• 1 other identifier: 17-1496
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the usefulness and results of orthopedic patients having access to a cell phone App called HealthLoop to utilize during the postoperative time period, compared to patients who have the usual postoperative management. The researchers want to investigate whether there any differences in outcomes and satisfaction in patients and providers.

Conditions

Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reporting a Problem Across al PPE-15 Domains

  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.

  90 days after index surgery

Secondary Outcomes (8)

• Visual Analog Scale (VAS) for Patient Satisfaction

  90 days after index surgery

• Length of Hospital Stay

  90 days after index surgery

• Number of Participants Discharged to Home

  90 days after index surgery

• Number Participants Who Were Readmitted to the Hospital

  90 days after index surgery

• Number Participants Who Visited the Emergency Department

  90 days after index surgery

Study Arms (2)

Group A

NO INTERVENTION

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

EXPERIMENTAL

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.

Device: HealthLoop mobile application

Interventions

HealthLoop mobile application DEVICE

Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary total hip arthroplasty or total knee arthroplasty patient
• Personal or surrogate consent to participate
• Patient has internet access or mobile access with a valid email address at the time of enrollment

You may not qualify if:

• Staged arthroplasty procedure within 6 months of the index procedure
• Abandoned email address of record
• Less than 14 days until date of surgery

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Accelero Health Partners, LLC: collaborator
• Zimmer Biomet: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Carlos Higuera
• Organization: Cleveland Clinic Florida

higuerc@ccf.org

9546595430

Study Officials

• Carlos A Higuera, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Quality and Patient Safety

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 29, 2018
• Study Start: April 17, 2018
• Primary Completion: June 17, 2020
• Study Completion: June 17, 2020
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)