NCT03358238

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1.6 years

First QC Date

November 26, 2017

Results QC Date

May 22, 2020

Last Update Submit

June 24, 2020

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (4)

  • 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.

    Study end (6 weeks)

Secondary Outcomes (2)

  • Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale

    Baseline, 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

    Baseline, study end (6 weeks)

Study Arms (2)

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.

Other: No weekly review

Weekly review

EXPERIMENTAL

Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.

Behavioral: Weekly review

Interventions

Weekly reviewBEHAVIORAL

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.

Weekly review
No weekly reviewOTHER

An interviewer will not review self-report symptoms and patterns collected from an activity tracker.

Also known as: Placebo
No weekly review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with bipolar disorder
  • Individuals with a smart-phone

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

  • 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.

    PMID: 31610074DERIVED

  • 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.

    PMID: 29748160DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Limitations and Caveats

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.

Results Point of Contact

Title
Amy Cochran
Organization
University of Wisconsin-Madison
cochran4@wisc.edu
608-262-0772

Study Officials

  • Amy L Cochran, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2017

First Posted

November 30, 2017

Study Start

November 27, 2017

Primary Completion

June 19, 2019

Study Completion

June 19, 2019

Last Updated

July 9, 2020

Results First Posted

July 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)