Observation of In-home Continuous Monitoring of Human Physiology Reported Pain Score Among Total Knee Replacement Patients (ObservePAIN)
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|ClinicalTrials.gov Identifier: NCT03789630|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : August 16, 2019
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 Type :||Observational|
|Estimated Enrollment :||115 participants|
|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|
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.
- 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.
- 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.
- 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.
- Hospital readmission [ Time Frame: 30 days ]Occurrence of all-cause hospital readmissions post-discharge
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
|Contact: Joyce Suang Bee Koh, A/Proffirstname.lastname@example.org|
|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|