AnxietyNCT02497755
Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety
A study testing App for smartphone and smartphone in people with Anxiety and Depression, run by University of Washington at 1 site in United States.
Trial summary
This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care patients receiving treatment for depression or anxiety delivered in an integrated primary care-based behavioral health program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- App for smartphone and smartphone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be part of the Behavioral Health Integration Program for anxiety and/or depression; Must have an iPhone or Android smartphone with a mobile voice calling plan with a US carrier; Fluent in English
Who cannot join
- Individual unable or unwilling to accept the terms of the Ginger.io terms of Use; Actively suicidal as determined by a healthcare professional; score of 3 on the Patient Health Questionnaire-9 item 9 (which assesses thoughts of self-harm); or documented history of 2 or more prior suicide attempts; Working diagnosis of psychotic disorder, bipolar disorder, dementia, active substance dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Neighborhood Clinic, Ravenna
Seattle, Washington, 98105
About this study
This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care patients receiving treatment for depression or anxiety delivered in an integrated primary care-based behavioral health program.
Read the detailed description
This research is a feasibility pilot study of a smartphone app using mixed methods. The research seeks to answer the question: "Is a mobile health tool for patient self-management feasible, useful, appropriate, and acceptable for patients and care managers for patients with depression or anxiety treated in an integrated primary-care based behavioral health program?"
- Conditions
- Anxiety, Depression
- Being tested
- App for smartphone, smartphone
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App for smartphoneBehavioural
A smartphone app will send psychoeducation and reminders to patients to complete self-report data, will collect passive data, and will provide aggregated information to a provider dashboard.
smartphoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Mobile app | Experimental | Participants will install an app on their smartphone to add to their treatment for depression and/or anxiety. Receives: Behavioral: App for smartphone; Device: smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable
The number of patients who rated the app was easy to use and the amount of time spent using the app as reasonable when asked about app acceptability in a qualitative interview and via a quantitative survey. Specific survey items included "The technology requires little effort to use," "The technology was easy to learn how to use," "The Ginger.io app is easy to use," and "The time required to answer questions in the Ginger.io app is reasonable." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to these items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable.
Measured: Four weeks after intervention started
App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable
The number of care managers who agreed that the app dashboard was easy to use and that the amount of time spent using the app dashboard was reasonable when asked about app acceptability and benefit vs. burden of use with regard to clinical workflow in a qualitative interview.
Measured: 8-16 weeks after final patient participant is enrolled
App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful
The number of patients who rated the app as useful to them when asked about app usefulness in a qualitative interview and via a quantitative survey. Specific survey items included "This technology is useful." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to this items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable.
Measured: Four weeks after intervention started
App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful
The number of care managers who expressed that the app was useful to them with regard to clinical workflow in a qualitative interview.
Measured: 8-16 weeks after final patient participant is enrolled
Secondary outcomes (5)
Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)
The mean total of patient app users' responses to the modified version of the Obtrusiveness Scale for Pervasive Technology, with a mean score of 13-39 indicating that the app is generally perceived as unacceptable/obtrusive, 40-64 indicating neutrality, and 65-91 indicating that the app is generally perceived as acceptable/unobtrusive.
Measured: During weeks 3 and 8
Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey.
The mean total of patient app users' responses to the Ginger.io product feedback survey, with a mean score of 7-21 indicating satisfaction with the app, 22-34 neutrality, and 35-49 expressing dissatisfaction.
Measured: Days 30, 56
Patient Use of the App as Measured by Percentage of App Surveys Completed.
The mean percentage of surveys presented to users through the app that were completed by patient app users in their first 8 weeks of using the app. App survey questions included weekly PHQ-9 and GAD-7 scales and daily measures of mood and medication use as well as satisfaction surveys.
Measured: Eight weeks after intervention started
Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale
The mean total of patient app users' responses to the 6 items in the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication scale, with a mean score of 0-5 indicating that participants never or almost never experienced good communication with their care team, 6-11 indicating that participants sometimes experienced good communication with their care team, 12-17 indicating that patients usually experienced good communication with their care teams, and a score of 24 indicating that patients always experienced good communication with their care team.
Measured: Weeks 4 and 8
Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.
The mean number of Follow-Up contacts between patient and care manager during the 8 weeks following the patient's activation of the app. (Other types of contacts with the care manager include Initial Assessment and Contact Attempt, but neither of these occurred during the time frame of app use.)
Measured: Eight weeks after intervention started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Bauer, University of Washington
- Investigators
- Amy M Bauer, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497755
- Sponsor's protocol ID
- 47871
- Status last verified
- Oct 2017
- First submitted
- 14 Feb 2015
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety
- ClinicalTrials.gov ID
- NCT02497755
- Acronym / sponsor ID
- 47871
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 2 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care patients receiving treatment for depression or anxiety delivered in an integrated primary care-based behavioral health program.
Detailed description
This research is a feasibility pilot study of a smartphone app using mixed methods. The research seeks to answer the question: "Is a mobile health tool for patient self-management feasible, useful, appropriate, and acceptable for patients and care managers for patients with depression or anxiety treated in an integrated primary-care based behavioral health program?"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile app | Experimental | Behavioral: App for smartphone, Device: smartphoneParticipants will install an app on their smartphone to add to their treatment for depression and/or anxiety. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be part of the Behavioral Health Integration Program for anxiety and/or depression; Must have an iPhone or Android smartphone with a mobile voice calling plan with a US carrier; Fluent in English
Key exclusion criteria (1 listed)
- Individual unable or unwilling to accept the terms of the Ginger.io terms of Use; Actively suicidal as determined by a healthcare professional; score of 3 on the Patient Health Questionnaire-9 item 9 (which assesses thoughts of self-harm); or documented history of 2 or more prior suicide attempts; Working diagnosis of psychotic disorder, bipolar disorder, dementia, active substance dependence
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 |
|---|---|---|
| App for smartphoneA smartphone app will send psychoeducation and reminders to patients to complete self-report data, will collect passive data, and will provide aggregated information to a provider dashboard. | Behavioural | Mobile app |
| smartphone | Device | Mobile app |
Primary outcome
App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable
Time frame: Four weeks after intervention started
The number of patients who rated the app was easy to use and the amount of time spent using the app as reasonable when asked about app acceptability in a qualitative interview and via a quantitative survey. Specific survey items included "The technology requires little effort to use," "The technology was easy to learn how to use," "The Ginger.io app is easy to use," and "The time required to answer questions in the Ginger.io app is reasonable." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to these items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable.
App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable
Time frame: 8-16 weeks after final patient participant is enrolled
The number of care managers who agreed that the app dashboard was easy to use and that the amount of time spent using the app dashboard was reasonable when asked about app acceptability and benefit vs. burden of use with regard to clinical workflow in a qualitative interview.
App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful
Time frame: Four weeks after intervention started
The number of patients who rated the app as useful to them when asked about app usefulness in a qualitative interview and via a quantitative survey. Specific survey items included "This technology is useful." All patients who expressed agreement ("Somewhat Agree," "Agree," or "Strongly Agree") to this items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable.
App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful
Time frame: 8-16 weeks after final patient participant is enrolled
The number of care managers who expressed that the app was useful to them with regard to clinical workflow in a qualitative interview.
5 secondary outcomes
Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)
Time frame: During weeks 3 and 8
Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey.
Time frame: Days 30, 56
Patient Use of the App as Measured by Percentage of App Surveys Completed.
Time frame: Eight weeks after intervention started
Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale
Time frame: Weeks 4 and 8
Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.
Time frame: Eight weeks after intervention started
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Amy M Bauer, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App for smartphone and smartphone in people with Anxiety and Depression, run by University of Washington at 1 site in United States.
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 1 inclusion and 1 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 2 Dec 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable (time frame: Four weeks after intervention started). 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 2 Dec 2017.