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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH112876 | U.S. NIH Grant/Contract | View source | |
| HUM00126732 | Other Identifier | University of Michigan | |
| 2017-1322 | Other Identifier | University of Wisconsin |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this study is to learn how to engage individuals with bipolar disorder in long-term monitoring of daily patterns of mood, stress, sleep, circadian rhythm, and medical adherence. Knowledge gained will be used to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder into an effective adaptive intervention.
Bipolar disorder is a chronic illness of profound shifts in mood ranging from mania to depression. Bipolar disorder is successfully treated by combining medication with psychosocial therapy, but care can prove inadequate in practice. With gaps in coverage and medication, along with imprecise guidelines on when, where, and how to intervene, promising psychosocial therapies require adaptive strategies to better address the specific needs of individuals in a timely manner. To accomplish this, however, requires evidence-based practices for adapting a psychosocial therapy. The long-term goal of this study is to address this knowledge gap, by establishing a mobile health platform for translating a psychosocial therapy in bipolar disorder into an effective adaptive intervention.
An important first step and the specific goal of this study is to answer the question of how to engage individuals with bipolar disorder in long-term monitoring of their daily patterns of mood, stress, sleep, circadian rhythm, and medical adherence. To answer this question, individuals with bipolar disorder will interact with a smart-phone application and activity tracker over six weeks. Individuals will record their symptoms twice-daily with the smart-phone application while activity, sleep, and heart rate are recorded with their activity tracker. In addition, individuals will be interviewed on a weekly basis. The study focuses on testing three engagement strategies: using activity trackers rather than self-reports; reviewing recorded symptoms with another person on a weekly basis; and synthesizing a person's data into charts and graphs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No weekly review | Placebo Comparator | Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone. |
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| Weekly review | Experimental | Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly review | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms | 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. | Study end (6 weeks) |
| Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions | 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). | Study end (6 weeks) |
| Average Proportion of Study Days With At Least 12 Hours of Activity Tracking | 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) | Study end (6 weeks) |
| Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale | 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. | Baseline, study end (6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy L Cochran, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States | ||
| University of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31610074 | Derived | Van Til K, McInnis MG, Cochran A. A comparative study of engagement in mobile and wearable health monitoring for bipolar disorder. Bipolar Disord. 2020 Mar;22(2):182-190. doi: 10.1111/bdi.12849. Epub 2019 Oct 25. | |
| 29748160 | Derived | Cochran A, Belman-Wells L, McInnis M. Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 10;7(5):e130. doi: 10.2196/resprot.9899. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Weekly Review | Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone. |
| FG001 | Weekly Review | Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Weekly Review | 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. |
| BG001 | Weekly Review |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms | 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. | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | Study end (6 weeks) |
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Adverse event data was collected over a period of six weeks for each individual participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Weekly Review | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant was hospitalized for manic symptoms from 2/05/2018 to 2/12/2018, went to ER while experiencing manic symptoms on 2/24/2018, and was hospitalized again for manic symptoms from 2/26/2018 to 3/5/2018. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fitbit Band Issue | Product Issues | Non-systematic Assessment | Issue with fit of activity tracker. Participants who indicated that their Fitbit did not fit properly returned the ill-fitting tracker and received a new one. |
Results regarding passive activity tracking may not generalize to other forms of passive tracking. Small sample sizes. Not powered to examine individual differences in responses to engagement survey at study end.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Cochran | University of Wisconsin-Madison | 608-262-0772 | cochran4@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2017 | Apr 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| No weekly review | Other | An interviewer will not review self-report symptoms and patterns collected from an activity tracker. |
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| Study end (6 weeks) |
| 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 | 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. | Baseline, study end (6 weeks) |
| Madison |
| Wisconsin |
| 53792 |
| United States |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diagnosis | Number of participants per bipolar diagnostic category. Participants were diagnosed using the Diagnostic Interview for Genetic Studies (DIGS)26 with diagnoses reviewed by two clinicians after initial evaluation and reevaluated when suspected to change based on a clinically relevant event. | Number | participants |
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All participants from both arms of the study were asked the same question regarding their symptom-monitoring preference. |
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| Primary | Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions | 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). | Posted | Mean | 95% Confidence Interval | proportion of study days | Study end (6 weeks) |
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| Primary | Average Proportion of Study Days With At Least 12 Hours of Activity Tracking | 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) | Posted | Mean | 95% Confidence Interval | proportion of study days | Study end (6 weeks) |
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| Primary | Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking | 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. | 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. | Posted | Number | 95% Confidence Interval | Proportion of participants | Study end (6 weeks) |
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| Secondary | Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, study end (6 weeks) |
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| Secondary | 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 | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, study end (6 weeks) |
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| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Weekly Review | 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. | 0 | 24 | 1 | 24 | 2 | 24 |
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| Participant Discontinuation | Product Issues | Non-systematic Assessment | Participant discontinued study due to discomfort with wearing Fitbit. |
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| Missed Interviews | Social circumstances | Non-systematic Assessment | Participant missed Week 5, 6, & 7 interviews. Participant completed week 7 interview outside of +/- 1 day window to complete their study participation |
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Null hypothesis is that among individuals with unequal adherence rates, the proportion of individuals with greater adherence to self-report over activity tracking in the Review Arm is equal to the proportion of individuals with greater adherence to self-report over activity tracking in the No Review Arm. |
| Chi-squared |
Degrees of freedom = 1 |
| 0.0828 |
| Superiority |
| Other |