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Observation of In-home Continuous Monitoring of Human Physiology Reported Pain Score Among Total Knee Replacement Patients (ObservePAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789630
Recruitment Status : Unknown
Verified August 2019 by Biofourmis Singapore Pte Ltd..
Recruitment status was:  Recruiting
First Posted : December 28, 2018
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Mundipharma Research Limited
Information provided by (Responsible Party):
Biofourmis Singapore Pte Ltd.

Study Description
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Brief Summary:

Historically, pain in humans has been measured using subjective ratings, such as the visual analog scale (VAS), to determine presence and severity. While this is important information, self-report is a problematic metric for both diagnostic and research purposes as it depends on their history with pain, cognitive and behavioral factors, and can vary over time. Over the past few years, significant advances have begun to be made in the development of measures as valid biomarkers or surrogate markers for the presence of acute and/or chronic pain. Measurement of various physiology parameters like heart rate, blood pressure, sweating, etc. have shown to be associated with the presence of pain and can aid clinical interpretation. It is acceptable that measurements extracted as a result of this singular assessment are not specific to pain and may be caused by something unrelated, which can weaken the validity.

The aim of this observational study is to assess whether patient-reported pain levels correlate with deviations in multivariate physiology biomarkers captured in a real-world ambulatory setting. This study will be conducted using a clinical-grade wearable sensor to continuously monitor patient's physiology (pain related biomarkers) and allow the subjects to actively report their pain score, symptoms and quality of life using a mobile-based application.


Condition or disease Intervention/treatment
Knee Arthroplasty Device: Continuous physiology monitoring in ambulatory setting pre and post surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation of In-home Continuous Monitoring of Human Physiology Reported Pain Score Among Total Knee Replacement Patients
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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Group/Cohort Intervention/treatment
Monitoring arm
Monitoring subjects undergoing total knee replacement surgery using the wearable biosensor to continuously monitor physiology biomarkers.
 Device: Continuous physiology monitoring in ambulatory setting pre and post surgery
This study will recruit 151 patients aged 21 to 80 years who will be undergoing total knee replacement surgery. All study participants undergoing total knee replacement surgery will be monitored using the wearable biosensor to continuously monitor physiology biomarkers. Participants will be followed for an estimated total of 39 days, beginning four days before surgery, the entire period during in-patient recovery (four to five days), and 30-days post-discharge at-home.


Outcome Measures
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Primary Outcome Measures :
  1. Pain Correlation [ Time Frame: 39 days ]
    Patient reported pain levels correlate with deviations in multivariate physiology biomarkers, which have shown to be associated with presence of pain.


Secondary Outcome Measures :
  1. Patient Satisfaction (using questionnaire) [ Time Frame: 39 days ]
    Smartphone based care model will allow patients to play an active role in management of their recovery, post-surgery. Measured using questionnaire upon study completion.

  2. HCP Satisfaction (using questionnaire) [ Time Frame: 39 days ]
    Post-acute patient monitoring enables clinicians to personalise treatment options by not just relying only on subjective measures of pain. Measured using questionnaire upon study completion.

  3. Hospital readmission [ Time Frame: 30 days ]
    Occurrence of all-cause hospital readmissions post-discharge


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
115 study participants, aged between 21 to 80 years, regardless of gender, who is undergoing total knee replacement surgery will be enrolled for the study upon receiving informed consent.
Criteria

Inclusion Criteria:

  • Men and women aged 21 to 80 years
  • Patients undergoing total knee replacement
  • Ability to provide informed consent
  • Able to commit to using the app and inputting data as needed during the study duration
  • Has access to an iPhone (minimum requirement iPhone 5S)

Exclusion Criteria:

  • Previous myocardial infarction (MI)
  • Known coronary artery disease - prior coronary revascularization
  • Previous stroke. Stroke is defined as new focal neurological deficit perspective more than 24 hours.
  • More than ongoing use of 2 or more anti-hypertensive agents.
  • Expected life expectancy less than 1 year.
  • Asthma or chronic lung disease requiring long-term medications or oxygen
  • Mental illness that in the clinical judgment of the investigator will affect participation in the study e.g. dementia
  • Inability to comply with the study protocol
  • Any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789630


Contacts
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Contact: Joyce Suang Bee Koh, A/Prof +6562223322 joyce.koh.s.b@singhealth.com.sg

Locations
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Singapore
Singapore General Hospital (SGH) Recruiting
Singapore, Singapore, 169865
Contact: Joyce Suang Bee Koh, A/Prof         
Principal Investigator: Joyce Suang Bee Koh, A/Prof         
Sub-Investigator: Tet Sen Howe, A/Prof         
Sub-Investigator: Ngai Nung Lo, Prof         
Sponsors and Collaborators
Biofourmis Singapore Pte Ltd.
Mundipharma Research Limited
More Information
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Responsible Party: Biofourmis Singapore Pte Ltd.
ClinicalTrials.gov Identifier: NCT03789630    
Other Study ID Numbers: CT002
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Biofourmis Singapore Pte Ltd.:
Knee Replacement
Wearable
Pain Score Quantification