Trial Outcomes & Findings for Modeling Mood Course to Detect Markers of Effective Adaptive Interventions (NCT NCT03358238)

Last Updated: 2020-07-09

Results Overview

Likelihood of using app over activity tracker is measured using a survey designed specifically for this study to evaluate participant engagement in monitoring symptoms. The relevant question asks 'Which are you more likely to use to monitor your symptoms' and has two mutually-exclusive options for an answer: 'An activity tracker' or 'A smart-phone app'. Engagement survey is conducted over the phone by an interviewer.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Study end (6 weeks)

Results posted on

2020-07-09

Participant Flow

Two participants were enrolled and subsequently excluded before the start of the study. One of these individuals died between the consent date and the start of the study, and the other was lost to follow-up between the consent date and study start.

Participant milestones

Participant milestones
Measure	No Weekly Review Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.	Weekly Review Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
Overall Study STARTED	23	25
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	No Weekly Review Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.	Weekly Review Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Weekly Review n=23 Participants Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone. No weekly review: An interviewer will not review self-report symptoms and patterns collected from an activity tracker.	Weekly Review n=25 Participants Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone. Weekly review: Each week in the study, an interviewer will review manic and depressive symptoms self-reported by a participant and patterns of activity, sleep, and heart rate collected by the participant's activity tracker.	Total n=48 Participants Total of all reporting groups
Age, Continuous	42.4 years STANDARD_DEVIATION 11.2 • n=5 Participants	41.0 years STANDARD_DEVIATION 10.6 • n=7 Participants	41.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	22 Participants n=7 Participants	41 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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
Region of Enrollment United States	23 participants n=5 Participants	25 participants n=7 Participants	47 participants n=5 Participants
Diagnosis Bipolar I	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Diagnosis Bipolar II	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Diagnosis Bipolar NOS	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Study end (6 weeks)

Population: The analysis population includes both arms (rather than reporting outcomes by arm). Goals of this study went beyond measuring arm effects. Here, the question of interest is across the sample, do individuals prefer self-reporting over using an activity tracker. It is not of interest to know if the intervention changes this preference.

Outcome measures

Outcome measures
Measure	All Participants n=47 Participants All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference.	No Review Arm Individuals who did not review weekly data with an interviewer
Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms	0.404 proportion of participants Interval 0.264 to 0.557	—

PRIMARY outcome

Timeframe: Study end (6 weeks)

For each individual, adherence rate for self-reporting symptoms is measured/defined as the proportion of study days with at least 50% completion of of daily self-reports questions (i.e. 6 questions completed out of a total of 12). This measure is the average adherence rate for individuals in each of the two intervention arms: individuals who review their data with an interviewer ('Weekly review' arm) vs those who do not review their data with an interviewer ('No weekly review' arm).

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference.	No Review Arm n=23 Participants Individuals who did not review weekly data with an interviewer
Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions	0.8185 proportion of study days Interval 0.6954 to 0.9415	0.8168 proportion of study days Interval 0.6865 to 0.947

PRIMARY outcome

Timeframe: Study end (6 weeks)

For each individual, adherence rate for activity tracking is measured as the proportion of study days with at least 12 hours of activity tracking. This measure is the average adherence rates among individuals in either arm: individuals who review their data weekly with an interviewer ('Weekly review' arm) compared to individuals who do not review their data weekly with an interviewer ('No weekly review' arm)

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference.	No Review Arm n=23 Participants Individuals who did not review weekly data with an interviewer
Average Proportion of Study Days With At Least 12 Hours of Activity Tracking	0.7688 proportion of study days Interval 0.6323 to 0.9054	0.7878 proportion of study days Interval 0.6376 to 0.9379

PRIMARY outcome

Timeframe: Study end (6 weeks)

Population: For an individual, adherence rate for self-report is proportion of days with at least 50% completion of self-report questions; adherence rate for activity tracking is proportion of days with at least 12 hours of activity tracking. Participants with no difference in adherence rates between self-report and activity tracking were excluded.

For each individual, adherence rate for activity tracking is measured as the proportion of study days with at least 12 hours of activity tracking, whereas adherence rate for self-reporting symptoms is measured as the proportion of study days with at least 50% of daily self-reports survey questions completed.

Outcome measures

Outcome measures
Measure	All Participants n=21 Participants All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference.	No Review Arm n=18 Participants Individuals who did not review weekly data with an interviewer
Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking	0.6667 Proportion of participants Interval 0.4303 to 0.8541	0.3889 Proportion of participants Interval 0.173 to 0.6425

SECONDARY outcome

Timeframe: Baseline, study end (6 weeks)

The Young Mania Rating Scale consists of clinician-rated 11 items to evaluate symptoms of mania, such as elevated mood, energy, and irritability. Item scores are added together to get a total score, ranging from 0 to 60. A higher score indicates more severe manic symptoms.

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference.	No Review Arm n=23 Participants Individuals who did not review weekly data with an interviewer
Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale	0.67 score on a scale Interval -0.54 to 1.88	0.91 score on a scale Interval -1.32 to 3.15

SECONDARY outcome

Timeframe: Baseline, study end (6 weeks)

The 17-Item Structured Interview Guide for the Hamilton Rating Scale for Depression consists of 17 clinician-rated items to evaluate symptoms of depression, such as guilt, fatigue, and depressed mood. Item scores are summed to get a total score, ranging from 0 to 52. Higher scores indicate more severe symptoms.

Outcome measures

Outcome measures
Measure	All Participants n=24 Participants All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference.	No Review Arm n=23 Participants Individuals who did not review weekly data with an interviewer
Average Change From Baseline in Severity of Depressive Symptoms, as Measured With the 17-item Structured Interview Guide for the Hamilton Rating Scale for Depression	0.67 score on a scale Interval -2.07 to 3.4	1.13 score on a scale Interval -1.43 to 3.69

Adverse Events

No Weekly Review

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Weekly Review

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	No Weekly Review n=23 participants at risk Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone. No weekly review: An interviewer will not review self-report symptoms and patterns collected from an activity tracker.	Weekly Review n=24 participants at risk Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone. Weekly review: Each week in the study, an interviewer will review manic and depressive symptoms self-reported by a participant and patterns of activity, sleep, and heart rate collected by the participant's activity tracker.
Psychiatric disorders Hospitalization	0.00% 0/23 • Adverse event data was collected over a period of six weeks for each individual participant.	4.2% 1/24 • Number of events 1 • Adverse event data was collected over a period of six weeks for each individual participant.

Other adverse events

Other adverse events
Measure	No Weekly Review n=23 participants at risk Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone. No weekly review: An interviewer will not review self-report symptoms and patterns collected from an activity tracker.	Weekly Review n=24 participants at risk Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone. Weekly review: Each week in the study, an interviewer will review manic and depressive symptoms self-reported by a participant and patterns of activity, sleep, and heart rate collected by the participant's activity tracker.
Product Issues Fitbit Band Issue	4.3% 1/23 • Number of events 1 • Adverse event data was collected over a period of six weeks for each individual participant.	4.2% 1/24 • Number of events 1 • Adverse event data was collected over a period of six weeks for each individual participant.
Product Issues Participant Discontinuation	0.00% 0/23 • Adverse event data was collected over a period of six weeks for each individual participant.	4.2% 1/24 • Number of events 1 • Adverse event data was collected over a period of six weeks for each individual participant.
Social circumstances Missed Interviews	4.3% 1/23 • Number of events 1 • Adverse event data was collected over a period of six weeks for each individual participant.	0.00% 0/24 • Adverse event data was collected over a period of six weeks for each individual participant.

Additional Information

Amy Cochran

University of Wisconsin-Madison

Phone: 608-262-0772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place