Trial Outcomes & Findings for Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD (NCT NCT04795323)
NCT ID: NCT04795323
Last Updated: 2023-12-21
Results Overview
The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks; they can select these activities from a list, and they can also add additional activities to the list. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (being the best: "not at all short of breath"). For each participant, the CRQ-SAI dyspnea domain score was calculated as the mean of numerical answers to the questions 1, 2, 3, 4, 5, excluding those questions not answered. Change was calculated as \[score at 12 weeks\] - \[score at baseline\].
COMPLETED
PHASE2
5 participants
Baseline (week 0) and Week 12.
2023-12-21
Participant Flow
This study followed a within-subject pre-post study design and was conducted as a hybrid (clinic visit/remote) study of a software as medical device (SaMD) in individuals with chronic obstructive pulmonary disease (IwCOPD), in a real-world setting.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated if any of the entry criteria were violated.
Participant milestones
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
|---|---|---|
|
Overall Study
Did not interact with TARA
|
1
|
0
|
Baseline Characteristics
Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
Baseline characteristics by cohort
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
n=4 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
n=1 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA is used independently at home by patients via an internet-enabled device and is a fully online digital system that offers guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 years
n=5 Participants
|
NA years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
The Chronic Respiratory - Self Administered Individualized (CRQ-SAI) dyspnea domain score
|
2.40 Score on a scale
n=5 Participants
|
4.80 Score on a scale
n=7 Participants
|
3.00 Score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) and Week 12.Population: Entered set (ES): This subject set includes all enrolled subjects with informed consent who completed the baseline Survey. Only subjects with post-baseline data are reported.
The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks; they can select these activities from a list, and they can also add additional activities to the list. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (being the best: "not at all short of breath"). For each participant, the CRQ-SAI dyspnea domain score was calculated as the mean of numerical answers to the questions 1, 2, 3, 4, 5, excluding those questions not answered. Change was calculated as \[score at 12 weeks\] - \[score at baseline\].
Outcome measures
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
n=3 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
n=1 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA is used independently at home by patients via an internet-enabled device and is a fully online digital system that offers guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
|---|---|---|
|
Change From Baseline in the Chronic Respiratory - Self Administered Individualized (CRQ-SAI) Dyspnea Domain Score at 12 Weeks
|
2.00 Score on a scale
Interval 0.6 to 4.0
|
-0.20 Score on a scale
Interval -0.2 to -0.2
|
PRIMARY outcome
Timeframe: Baseline (week 0) and Week 12.Population: Entered set (ES): This subject set includes all enrolled subjects with informed consent who completed the baseline Survey. Only subjects with post-baseline data are reported.
Number of subjects with increase from baseline in the CRQ-SAI dyspnea domain score at 12 weeks of at least 0.5, the minimal clinically important difference (MCID). The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (being the best: "not at all short of breath"). For each participant, the CRQ-SAI dyspnea domain score was calculated as the mean of numerical answers to the questions 1, 2, 3, 4, 5, excluding those questions not answered. Change was calculated as \[score at 12 weeks\] - \[score at baseline\].
Outcome measures
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
n=3 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
n=1 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA is used independently at home by patients via an internet-enabled device and is a fully online digital system that offers guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
|---|---|---|
|
Number of Subjects With Increase From Baseline in the CRQ-SAI Dyspnea Domain Score at 12 Weeks of at Least 0.5
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0) and Week 12.Population: Entered set (ES): This subject set includes all enrolled subjects with informed consent who completed the baseline Survey. Only subjects with post-baseline data are reported.
Daily activity levels were measured using an activity tracker (Reemo) over 2-week periods. The average steps/day were counted over a period of up to 14 days at baseline and at Week 12. A "valid day" was defined as a day where the activity tracker records at least 8 active hours during waking hours (7 am to 10 pm local time for the participant). To calculate the average number of steps/day at baseline (also for Week 12), the data from the prior 14 days were examined. At least 4 valid days out of the 14 days were needed for analysis, but they did not have to be consecutive days. If there were fewer than 4 valid days, the average number of steps/day was not calculated. The average steps/day was calculated as the average over the valid days. Change was calculated as baseline value - week 12 score value.
Outcome measures
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
n=3 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
n=1 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA is used independently at home by patients via an internet-enabled device and is a fully online digital system that offers guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
|---|---|---|
|
Change From Baseline in Average Number of Steps Measured by the Activity Tracker at Week 12
|
-41.4 steps per day
Interval -564.8 to 629.5
|
259.5 steps per day
Interval 259.5 to 259.5
|
SECONDARY outcome
Timeframe: Baseline (week 0) and Week 12.Population: Entered set (ES): This subject set includes all enrolled subjects with informed consent who completed the baseline Survey. Only subjects with post-baseline data are reported.
Daily activity levels were measured using an activity tracker (Reemo) over 2-week periods. Cadence (steps/min) was calculated as number of steps walked per day divided by the walk time per day (in minutes), then averaged over valid days to produce the average cadence. A "valid day" was defined as a day where the activity tracker records at least 8 active hours during waking hours (7 am to 10 pm local time for the participant). To calculate the average cadence (steps/min) at baseline (also for Week 12), the data from the prior 14 days were examined. At least 4 valid days out of the 14 days were needed for analysis, but they did not have to be consecutive days. If there were fewer than 4 valid days, the average cadence (steps/min) was not calculated. The average cadence (steps/min) was calculated as the average over the valid days. Change was calculated as baseline value - week 12 score value.
Outcome measures
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
n=3 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
n=1 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA is used independently at home by patients via an internet-enabled device and is a fully online digital system that offers guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
|---|---|---|
|
Change From Baseline in Average Cadence (Steps/Min) Measured by the Activity Tracker at Week 12
|
0.00 Steps per minute
Interval -1.63 to 1.19
|
0.67 Steps per minute
Interval 0.67 to 0.67
|
SECONDARY outcome
Timeframe: Baseline (week 0) and Week 12.Population: Entered set (ES): This subject set includes all enrolled subjects with informed consent who completed the baseline Survey. Only subjects with post-baseline data are reported.
C-PPAC (with focus on the difficulty domain score). The C-PPAC questionnaire has 12 questions about activities done in the last 7 days, and also records two scores (weekly steps and vector magnitude units) from an activity monitor. Three scores are generated from the C-PPAC (difficulty with physical activity, amount of physical activity and total physical activity). Only the difficulty domain score of the C-PPAC will be analyzed in this study. For each participant, the raw score for the C-PPAC difficulty domain is calculated as the sum of the numerical answers to the 10 questions 3-12. Each numerical answer ranges from 0 (most difficult) to 4 (no difficulty). The range of the raw score is 0-40 (with 0 being the most difficult and 40 being no difficulty). This raw score is then scaled to a 0-100 Rasch scaled score (with 0 being the most difficult and 100 being no difficulty). Change was calculated as baseline value - week 12 score value.
Outcome measures
| Measure |
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
n=3 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA was used independently at home by patients via an internet-enabled device and was a fully online digital system that offered guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication) in TARA version 3.1 (v3.1). The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
n=1 Participants
Technology-Assisted Respiratory Adherence (TARA) is a digital behaviour change intervention (DBCI) intended to support patients with chronic obstructive pulmonary disease (COPD) in managing their condition by adopting and sustaining clinically recommended (evidence-based) self-management behaviours. TARA is used independently at home by patients via an internet-enabled device and is a fully online digital system that offers guidance on the self-management of COPD, targeting non-pharmacological self-management support (self-monitoring, pursed lip breathing, pacing and energy conservation, and adherence to prescribed rescue medication in TARA version 3.1 (v3.1). Additionally, in TARA v3.2, pharmacological self-management support module (including modules on inhaler techniques and correct use of inhalers, plus a module to close track inhaler use and symptoms over a 7-day period \[medication adherence\]) was included. The study comprised a screening (pre-TARA) period (which included a 2-week run-in period), a 12-week intervention period (TARA study period), and a follow-up period (post-TARA).
|
|---|---|---|
|
Change From Baseline in the Difficulty Domain of the Clinical Visits PROactive Physical Activity in COPD Instrument (C-PPAC) at Week 12
|
14 Score on a scale
Interval -4.0 to 20.0
|
0 Score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place