RecoveryNCT04824066
The Role of Wearable Devices in Predicting and Detecting Complications and Adverse Events
An observational study of Recovery and Treatment Complication, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recovery, Treatment Complication
- What is being tested?
- Device: Wearable Device
- Type of treatment
- Medical device
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2021to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing treatment for benign or malignant conditions that are amenable to wearing a device of interest and meet the inclusion and exclusion criteria above will be approached for informed consent.
Who may be able to join
- Age 18 years or older
- Individuals scheduled to undergo one of the following surgical or non-surgical treatments: cardiothoracic surgery, orthopedic surgery, vascular surgery, colorectal surgery, pancreatic surgery, other major abdominal surgeries, treatment for chronic disease, or systemic therapy (i.e., chemotherapy, immunotherapy, or targeted therapy), radiotherapy, or ablation.
- Amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap).
- Individuals willing to provide informed consent and who have capacity for all study procedures
Who cannot join
- Individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol.
- Any pregnant participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Chi-Fu J Yang, M.D., 814-574-8695, cjyang@mgh.harvard.edu
About this study
The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions.
Read the detailed description
This is a multi-center non-randomized prospective cohort study using wearable devices and machine learning to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions.
Patients who meet the inclusion and exclusion criteria will be enrolled consecutively with verbal informed consent from the time this protocol is approved by the IRB until 2,400 subjects are enrolled. At ~30 days before treatment the subjects will have a wearable device (such as a Fitbit) placed on their wrist and will wear the device for up to 5 years following treatment. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear and data will be analyzed by our collaborators at Case Western Reserve University.
- Conditions
- Recovery, Treatment Complication
- Being tested
- Device: Wearable Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Wearable DeviceDevice
A Wearable Device will be placed on the wrist of the patient ~30 days prior to the patient's scheduled treatment and for up to 5 years following treatment. The device will record activity in terms of steps, sleep quality, heart rate, etc.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Adults patients who are scheduled to undergo treatment for a benign or malignant condition and meet the inclusion and exclusion criteria. Receives: Device: Device: Wearable Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of complications and adverse events using machine learning analysis of patient biometric data.
Proportion of complications detected by the machine learning algorithm.
Measured: Five Years
Prediction of the quality of recovery after treatment using patient biometric data.
Proportion of patients whose quality of recovery is correctly predicted by the machine learning algorithm.
Measured: Four Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start10 Jul 2021
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RecoveryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Chi-Fu Jeffrey Yang, Massachusetts General Hospital
- Investigators
- Chi-Fu Jeffrey Yang, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824066
- Sponsor's protocol ID
- 2020P002984
- Status last verified
- May 2026
- First submitted
- 11 Mar 2021
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang Z, Wang D, Potter AL, Zhang L, Zhang Y, Rettner B, Zhu A, McCarthy M, Guo Q, Srinivasan D, Avondet MC, Baird J, Ordyna C, Aaron A, Castillo AJ, Pope A, Cheney B, Mohseni M, Hanna G, Cranor J, Kim J, Dharani M, Morris H, Chen X, Li J, Panda N, Costantino C, Sachdeva UM, Langer NB, Osho AA, Auchincloss HG, Lanuti M, Jeffrey Yang CF, Li X. A novel wearables-based sleep quality index to quantify postoperative sleep quality. J Thorac Cardiovasc Surg. 2026 Sep;172(3):777-787.e8. doi: 10.1016/j.jtcvs.2026.04.045. Epub 2026 May 8.
PubMed 42107634Wang D, Fang Z, Zhu A, Rettner B, Potter AL, McCarthy M, Zhang L, Kim J, Zhang Y, Powell J, Pope A, Beqari J, Cranor J, Smock G, Warikoo IM, Aaron A, Guo Q, Hanna G, Mitri J, Zarif M, Melki A, Wilkins I, Lin MW, Lee H, Costantino C, Furlow PW, Sachdeva UM, Auchincloss HG, Wright C, Lanuti M, Li X, Jeffrey Yang CF. Changes in patient-reported quality of life after lobectomy versus sublobar resection. J Thorac Cardiovasc Surg. 2026 Apr;171(4):826-835.e5. doi: 10.1016/j.jtcvs.2025.10.040. Epub 2025 Nov 8.
PubMed 41213469
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Wearable Devices in Predicting and Detecting Complications and Adverse Events
- ClinicalTrials.gov ID
- NCT04824066
- Acronym / sponsor ID
- 2020P002984
- Conditions
- Recovery, Treatment Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions.
Detailed description
This is a multi-center non-randomized prospective cohort study using wearable devices and machine learning to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions.
Patients who meet the inclusion and exclusion criteria will be enrolled consecutively with verbal informed consent from the time this protocol is approved by the IRB until 2,400 subjects are enrolled. At ~30 days before treatment the subjects will have a wearable device (such as a Fitbit) placed on their wrist and will wear the device for up to 5 years following treatment. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear and data will be analyzed by our collaborators at Case Western Reserve University.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: Device: Wearable DeviceAdults patients who are scheduled to undergo treatment for a benign or malignant condition and meet the inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment for benign or malignant conditions that are amenable to wearing a device of interest and meet the inclusion and exclusion criteria above will be approached for informed consent.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Individuals scheduled to undergo one of the following surgical or non-surgical treatments: cardiothoracic surgery, orthopedic surgery, vascular surgery, colorectal surgery, pancreatic surgery, other major abdominal surgeries, treatment for chronic disease, or systemic therapy (i.e., chemotherapy, immunotherapy, or targeted therapy), radiotherapy, or ablation.
- Amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap).
- Individuals willing to provide informed consent and who have capacity for all study procedures
Key exclusion criteria (2 listed)
- Individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol.
- Any pregnant participant.
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 |
|---|---|---|
| Device: Wearable DeviceA Wearable Device will be placed on the wrist of the patient ~30 days prior to the patient's scheduled treatment and for up to 5 years following treatment. The device will record activity in terms of steps, sleep quality, heart rate, etc. | Device | Treatment Group |
Primary outcome
Early detection of complications and adverse events using machine learning analysis of patient biometric data.
Time frame: Five Years
Proportion of complications detected by the machine learning algorithm.
Prediction of the quality of recovery after treatment using patient biometric data.
Time frame: Four Years
Proportion of patients whose quality of recovery is correctly predicted by the machine learning algorithm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 42107634Fang Z, Wang D, Potter AL, Zhang L, Zhang Y, Rettner B, Zhu A, McCarthy M, Guo Q, Srinivasan D, Avondet MC, Baird J, Ordyna C, Aaron A, Castillo AJ, Pope A, Cheney B, Mohseni M, Hanna G, Cranor J, Kim J, Dharani M, Morris H, Chen X, Li J, Panda N, Costantino C, Sachdeva UM, Langer NB, Osho AA, Auchincloss HG, Lanuti M, Jeffrey Yang CF, Li X. A novel wearables-based sleep quality index to quantify postoperative sleep quality. J Thorac Cardiovasc Surg. 2026 Sep;172(3):777-787.e8. doi: 10.1016/j.jtcvs.2026.04.045. Epub 2026 May 8.
- Derived from this study: PubMed 41213469Wang D, Fang Z, Zhu A, Rettner B, Potter AL, McCarthy M, Zhang L, Kim J, Zhang Y, Powell J, Pope A, Beqari J, Cranor J, Smock G, Warikoo IM, Aaron A, Guo Q, Hanna G, Mitri J, Zarif M, Melki A, Wilkins I, Lin MW, Lee H, Costantino C, Furlow PW, Sachdeva UM, Auchincloss HG, Wright C, Lanuti M, Li X, Jeffrey Yang CF. Changes in patient-reported quality of life after lobectomy versus sublobar resection. J Thorac Cardiovasc Surg. 2026 Apr;171(4):826-835.e5. doi: 10.1016/j.jtcvs.2025.10.040. Epub 2025 Nov 8.
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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.
Chi-Fu Jeffrey Yang principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recovery and Treatment Complication, run by Massachusetts General Hospital 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Fu Jeffrey Yang, MD (617-726-5200, cjyang@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of complications and adverse events using machine learning analysis of patient biometric data. (time frame: Five Years). The study lists 2 primary outcomes in all. 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 NCT04824066, which also lists 2 linked publications.
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 28 May 2026.