Trial Outcomes & Findings for Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder (NCT NCT04535583)

NCT ID: NCT04535583

Last Updated: 2023-11-15

Results Overview

The percentage of days carried the smartphone at least 8 hours per day.

• Recruitment status: COMPLETED
• Target enrollment: 65 participants
• Primary outcome timeframe: 84 days (or 12-weeks)
• Results posted on: 2023-11-15

Participant Flow

Participant milestones

Measure	EMA Plus Passive Sensing (Social Media Optional) Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.
Overall Study STARTED	65
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	EMA Plus Passive Sensing (Social Media Optional) Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder

Baseline characteristics by cohort

Measure	EMA Plus Passive Sensing (Social Media Optional) n=65 Participants Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.
Age, Continuous	37.2 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex/Gender, Customized Male	32 participants n=5 Participants
Sex/Gender, Customized Female	31 participants n=5 Participants
Sex/Gender, Customized Other	2 participants n=5 Participants
Race/Ethnicity, Customized White	46 participants n=5 Participants
Race/Ethnicity, Customized Non-white/more than one race	19 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino/of Spanish origin	14 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	51 participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 84 days (or 12-weeks)

Population: 62 out of the 65 participants completed the baseline visit and received the study smartphone or had the study app setup on their personal smartphone to contribute passive data via smartphone.

The percentage of days carried the smartphone at least 8 hours per day.

Outcome measures

Measure

EMA Plus Passive Sensing (Social Media Optional) n=62 Participants Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.

Smartphone Sensor Data

94.2 mean percentage of days Interval 90.8 to 97.6

SECONDARY outcome

Timeframe: At baseline

Population: 49 out of 56 participants had social media accounts. Therefore, the denominator used to determine the percentage of participants who consented to download social media data was the total number of participants with social media accounts.

The percentage of participants who consented to download social media data.

Outcome measures

Measure

EMA Plus Passive Sensing (Social Media Optional) n=56 Participants Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.

Social Media Data

49 Participants

SECONDARY outcome

Timeframe: up to 3 times per day for 84 days (or 12-weeks)

Population: 62 out of the 65 participants completed the baseline visit and received the study smartphone or had the study app setup on their personal smartphone to respond to ecological momentary assessments.

The response rate to Ecological Momentary Assessment prompts during the 12-week study phase. The EMA Response Rate for each participant is the number of EMAs responded to over the last 83 days of the study (up to 249 responses [83 days X 3 EMA]) (yields a percentage). The total mean EMA response rate was based on the EMA response rate (percentage) across all participants in the study (N=62).

Outcome measures

Measure

EMA Plus Passive Sensing (Social Media Optional) n=62 Participants Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.

The Number of Ecological Momentary Assessments (EMA) With Response

70.0 mean percentage of EMA response rate Interval 63.5 to 81.4

SECONDARY outcome

Timeframe: 84 days (or 12-weeks)

Population: 62 out of the 65 participants completed the baseline visit and received the study smartwatch to contribute passive data via smartwatch.

The percentage of days wore the smartwatch at least 18 hours per day.

Outcome measures

Measure

EMA Plus Passive Sensing (Social Media Optional) n=62 Participants Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.

Smartwatch Sensor Data

73.7 Mean percentage of days Interval 67.7 to 79.7

Adverse Events

EMA Plus Passive Sensing (Social Media Optional)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EMA Plus Passive Sensing (Social Media Optional) n=65 participants at risk Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team.
Psychiatric disorders Suicidal Ideation	3.1% 2/65 • Number of events 2 • 11 months
Skin and subcutaneous tissue disorders Rash	4.6% 3/65 • Number of events 3 • 11 months

Additional Information

Dr. Lisa A. Marsch

Geisel School of Medicine at Dartmouth

Phone: 603-646-7092

Email: lisa.a.marsch@dartmouth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place