Arthroplasty, Replacement, KneeNCT03481595

Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop

A study testing HealthLoop mobile application in people with Arthroplasty, Replacement, Knee and Arthroplasty, Replacement, Hip, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip
What is being tested?: HealthLoop mobile application
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 294 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2018to 17 Jun 2020
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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop to Manage the Episode of Care for THA and TKA Bundles

Read the detailed description

HealthLoop is a mobile-device application (cell phone App) that allows physicians to monitor for signs and symptoms of potential adverse events, and communicate with patients during the postoperative recovery process. The platform enables doctors to identify patients at risk of decline in the follow up period. Patients are engaged through mobile and web-based surveys, reminders, and information personalized to the patient's specific condition or treatment plan. Alerts are sent to physicians about patients who are at risk of treatment failures, complications, or hospital readmissions. Physicians are informed if patients are trending toward an adverse outcome based on the patient's responses.

Patients who choose to participate in this Research Study will be randomly assigned (like a flip of a coin) to one of two groups. Group A will receive standard, routine medical care. Group B will be asked to use the HealthLoop application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients will not be able to choose which group they will be in.

Conditions: Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip
Being tested: HealthLoop mobile application

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03481595
Study group	Role	What they receive
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. Receives: Device: HealthLoop mobile application

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 90 days after index surgery

Secondary outcomes (8)

Visual Analog Scale (VAS) for Patient Satisfaction
Satisfaction measurement tool measured on a scale from 0-100 mm. Where 0 = not satisfied and 100 = entirely satisfied.
Measured: 90 days after index surgery
Length of Hospital Stay
A count of the number of days the patient was admitted to the hospital after the index procedure prior to being discharged. Measured in days.
Measured: 90 days after index surgery
Number of Participants Discharged to Home
Was the patient routinely discharged to home? Reported as yes or no.
Measured: 90 days after index surgery
Number Participants Who Were Readmitted to the Hospital
A count of the number of hospital readmissions related to the index procedure within 90 days after the index procedure.
Measured: 90 days after index surgery
Number Participants Who Visited the Emergency Department
A count of the number of emergency department visits related to the index procedure within 90 days after the index procedure.
Measured: 90 days after index surgery
Number Participants With 0, 1, 2, or 3+ Outpatient Visits
A 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.
Measured: 90 days after index surgery
Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team
A count of the number of telephone calls with the surgical team related to the index procedure within 90 days after the index procedure.
Measured: 90 days after index surgery
Number of Participants Who Had a Reoperation
A count of the number of reoperations related to the index procedure within 90 days after the index procedure.
Measured: 90 days after index surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 201817 Jun 2020

First posted29 Mar 2018
Study start17 Apr 2018
Primary completion17 Jun 2020
Study completion17 Jun 2020

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 Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03481595
Sponsor's protocol ID: 17-1496
Status last verified: Oct 2021
First submitted: 2 Mar 2018
Last updated: 24 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)

All Arthroplasty, Replacement, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop to Manage the Episode of Care for THA and TKA Bundles
ClinicalTrials.gov ID: NCT03481595
Acronym / sponsor ID: 17-1496
Conditions: Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Accelero Health Partners, LLC, Zimmer Biomet
Study start: 17 Apr 2018 (actual)
Primary completion: 17 Jun 2020 (actual)
Study completion: 17 Jun 2020 (actual)
First posted: 29 Mar 2018 (actual)
Results: Posted 24 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Device: HealthLoop mobile applicationGroup 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

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

Primary outcome

Percentage of Participants Reporting a Problem Across al PPE-15 Domains
Time frame: 90 days after index surgery
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.

8 secondary outcomes

Visual Analog Scale (VAS) for Patient Satisfaction
Time frame: 90 days after index surgery
Length of Hospital Stay
Time frame: 90 days after index surgery
Number of Participants Discharged to Home
Time frame: 90 days after index surgery
Number Participants Who Were Readmitted to the Hospital
Time frame: 90 days after index surgery
Number Participants Who Visited the Emergency Department
Time frame: 90 days after index surgery
Number Participants With 0, 1, 2, or 3+ Outpatient Visits
Time frame: 90 days after index surgery
Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team
Time frame: 90 days after index surgery
Number of Participants Who Had a Reoperation
Time frame: 90 days after index surgery

Results and safety

Results posted to the registry on 24 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	146	143
Group B	148	127

Primary outcome: Percentage of Participants Reporting a Problem Across al PPE-15 Domains

Time frame: 90 days after index surgery. Mean (Standard Deviation). Unit: percent of participants

Measure	Group A n = 143	Group B n = 127
Value	12.6 (15.3)	9.5 (13.2)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 90 days following total knee or total hip arthroplasty. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	11 of 143 (7.7%)	12 of 143 (8.4%)	0 of 143
Group B	14 of 127 (11%)	10 of 127 (7.9%)	1 of 127

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Arthroplasty, Replacement, Knee

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)

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.

Carlos A Higuera, MD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HealthLoop mobile application in people with Arthroplasty, Replacement, Knee and Arthroplasty, Replacement, Hip, run by The Cleveland Clinic at 1 site in United States.

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 3 inclusion and 3 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 24 Nov 2021). 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?

Percentage of Participants Reporting a Problem Across al PPE-15 Domains (time frame: 90 days after index surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03481595.

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 24 Nov 2021.