Trial Outcomes & Findings for Post-Market Surveillance With a Novel mHealth Platform (NCT NCT03436082)

Results Overview

Disease-specific PROMs were collected using email notification to all patients over the course of the study. Disease-specific PROMs were emailed to patients at enrollment (preprocedure) and 1, 4, and 8 weeks post-procedure and were tailored to patients depending on the procedure they received. For each PROM, the date and time that it was emailed to patients, the time it was initiated, and the time at which the final response was received were all available.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	Bariatric (Sleeve Gastrectomy/Roux-en-Y)	AF Ablation Atrial Fibrillation Ablation
Overall Study STARTED	30	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Bariatric (Sleeve Gastrectomy/Roux-en-Y)	AF Ablation Atrial Fibrillation Ablation
Overall Study Did not undergo procedure	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bariatric n=30 Participants (Sleeve Gastrectomy/Roux-en-Y)	AF Ablation n=30 Participants Atrial Fibrillation Ablation	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=30 Participants	16 Participants n=30 Participants	43 Participants n=60 Participants
Age, Categorical >=65 years	3 Participants n=30 Participants	14 Participants n=30 Participants	17 Participants n=60 Participants
Age, Continuous	46.4 Years STANDARD_DEVIATION 12.5 • n=30 Participants	62.4 Years STANDARD_DEVIATION 10 • n=30 Participants	55.2 Years STANDARD_DEVIATION 13.5 • n=60 Participants
Sex: Female, Male Female	23 Participants n=30 Participants	12 Participants n=30 Participants	35 Participants n=60 Participants
Sex: Female, Male Male	7 Participants n=30 Participants	18 Participants n=30 Participants	25 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Assessed for # disease-specific PROMs completed

Disease-specific PROMs were collected using email notification to all patients over the course of the study. Disease-specific PROMs were emailed to patients at enrollment (preprocedure) and 1, 4, and 8 weeks post-procedure and were tailored to patients depending on the procedure they received. For each PROM, the date and time that it was emailed to patients, the time it was initiated, and the time at which the final response was received were all available.

Outcome measures

Outcome measures
Measure	Bariatric n=75 # PROMs distributed (Sleeve Gastrectomy/Roux-en-Y)	AF Ablation n=73 # PROMs distributed Atrial Fibrillation Ablation
Number of Disease-Specific PROMs Completed	64 # PROMs completed	59 # PROMs completed

PRIMARY outcome

Timeframe: 5 weeks

Population: Assessed for # PROMs completed

Post-procedure PROMs were collected using email notification to all patients over the course of the study. Post-procedure PROMs were emailed to patients twice weekly for a total of 5 weeks post-procedure. Bariatric surgery patients were asked two questions: (1) if they had pain (yes/no) and, if yes, to rate their pain on a scale of 1-10 and (2) if they had an appetite (yes/no) and, if yes, to rate their appetite on a scale of 1-10. Atrial fibrillation ablation patients were asked about pain, as well as whether they had palpitations and, if yes, to rate both symptoms on a scale of 1-10. For each PROM, the date and time that it was emailed to patients, the time it was initiated, and the time at which the final response was received were all available.

Outcome measures

Outcome measures
Measure	Bariatric n=260 # PROMs distributed (Sleeve Gastrectomy/Roux-en-Y)	AF Ablation n=279 # PROMs distributed Atrial Fibrillation Ablation
Number of Post-Procedure PROMs Completed	203 # PROMs completed	237 # PROMs completed

PRIMARY outcome

Timeframe: 8 weeks

Population: Assessed for # of device syncs

Device syncs are operationally defined as the # of patients who synced their device at all required time points over the 8-week post-procedure period.

Outcome measures

Outcome measures
Measure	Bariatric n=29 Participants (Sleeve Gastrectomy/Roux-en-Y)	AF Ablation n=30 Participants Atrial Fibrillation Ablation
Device Syncs Fitbit	17 # patients who synced at all time points	14 # patients who synced at all time points
Device Syncs Disease-Specific (Withings Body Scale/Kardia Mobile)	11 # patients who synced at all time points	15 # patients who synced at all time points

PRIMARY outcome

Timeframe: 8 weeks

Population: Assessed for # times encounter date, encounter type, and encounter primary diagnosis matched between the data sharing platform, Hugo, and the patient's EHR

For EHR data, we validated the following components over 8 weeks follow-up: encounter date, encounter type, and encounter primary diagnosis. Specifically, we determined if encounters aggregated by the patient-centered health data sharing platform, Hugo, matched encounters listed in each patient's EHR.

Outcome measures

Outcome measures
Measure	Bariatric n=106 Patient Records (Sleeve Gastrectomy/Roux-en-Y)	AF Ablation n=115 Patient Records Atrial Fibrillation Ablation
Electronic Health Record Data Validation Encounter Date	105 Number of matched records	110 Number of matched records
Electronic Health Record Data Validation Encounter Type	103 Number of matched records	100 Number of matched records
Electronic Health Record Data Validation Primary Diagnosis	103 Number of matched records	101 Number of matched records

Adverse Events

Bariatric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AF Ablation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Ross, MD, MHS

Yale School of Medicine

Phone: 203-785-2987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place