Bipolar Affective DisorderNCT03275714
Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
A study testing Smartphone APP in people with Bipolar Affective Disorder, run by Medical University of Graz at 1 site in Austria.
Trial summary
The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior. The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- Smartphone APP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2017to 20 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written consent of the participant after clarification
- Patients with a bipolar affective disorder (group of patients) Or control persons without a mental illness (control group)
- Age between 18 and 70 years
- Knowledge about using a smartphone
Who cannot join
- Rejection of participation
- Lack of knowledge about how to deal with a smartphone
- Congenital / early-childhood intelligence reduction
- Moderate / severe dementia
Trial locations and contacts
1 site in 1 country.
Austria1 site
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
Graz, 8010
About this study
The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior.
The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder.
Secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.
Furthermore it will be evaluated whether the BiP-app can find applicability in the examined patient group.
Study design: Clinical evaluation of a medical device without CE mark; Parallel study design
- Conditions
- Bipolar Affective Disorder
- Being tested
- Smartphone APP
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone APPDevice
Participants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.
| Study group | Role | What they receive |
|---|---|---|
| People With a Bipolar Affective Disorder | Active comparator | Not described Receives: Device: Smartphone APP |
| Control subjects without a psychiatric disorder | Active comparator | Not described Receives: Device: Smartphone APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration
in minutes
Measured: 6 months
Movement behaviour
evaluated through motion sensors and localization services
Measured: 6 months
Mood
evaluated by mood surveys
Measured: 6 months
Communication behaviour
Frequency of usage of communication services
Measured: 6 months
Secondary outcomes (1)
Patient acceptance
evaluated by a questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Sep 2017
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275714
- Sponsor's protocol ID
- bipolarAPP
- Status last verified
- Dec 2019
- First submitted
- 31 Aug 2017
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
- ClinicalTrials.gov ID
- NCT03275714
- Acronym / sponsor ID
- bipolarAPP
- Conditions
- Bipolar Affective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior.
The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder.
Secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.
Furthermore it will be evaluated whether the BiP-app can find applicability in the examined patient group.
Study design: Clinical evaluation of a medical device without CE mark; Parallel study design
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People With a Bipolar Affective Disorder | Active comparator | Device: Smartphone APP |
| Control subjects without a psychiatric disorder | Active comparator | Device: Smartphone APP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written consent of the participant after clarification
- Patients with a bipolar affective disorder (group of patients) Or control persons without a mental illness (control group)
- Age between 18 and 70 years
- Knowledge about using a smartphone
Key exclusion criteria (4 listed)
- Rejection of participation
- Lack of knowledge about how to deal with a smartphone
- Congenital / early-childhood intelligence reduction
- Moderate / severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone APPParticipants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys. | Device | Control subjects without a psychiatric disorder, People With a Bipolar Affective Disorder |
Primary outcome
Sleep duration
Time frame: 6 months
in minutes
Movement behaviour
Time frame: 6 months
evaluated through motion sensors and localization services
Mood
Time frame: 6 months
evaluated by mood surveys
Communication behaviour
Time frame: 6 months
Frequency of usage of communication services
1 secondary outcome
Patient acceptance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone APP in people with Bipolar Affective Disorder, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.