DepressionNCT04499729
Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation
A study testing IntelliCare and Treatment as Usual (TAU) in people with Depression, run by Adaptive Health, Inc at 1 site in United States.
Trial summary
The overarching aim of the proposed project is to conduct a pragmatic, quality improvement evaluation of the IntelliCare Platform for improving processes of care in the Rush Collaborative Care program, and improving patient population depression outcomes, to determine the long-term utility of IntelliCare for Rush. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- IntelliCare and Treatment as Usual (TAU)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in Rush Collaborative Care service
- Owns a personal smartphone
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The overarching aim of the proposed project is to conduct a pragmatic, quality improvement evaluation of the IntelliCare Platform for improving processes of care in the Rush Collaborative Care program, and improving patient population depression outcomes, to determine the long-term utility of IntelliCare for Rush.
Read the detailed description
This study is a pragmatic, system-wide rollout quality improvement evaluation design displayed in Figure 1. The Rush IRB has waived consent for this quality improvement trial. Data from the EHR will be used beginning December 1, 2019. The first care manager (CM) will begin enrolling patients into IntelliCare in September, 2020. Additional CMs will begin using IntelliCare at approximately 3 month intervals. In September 2021, support for IntelliCare from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare Platform.
Patients Data from all patients, aged 18 or older, enrolled collaborative care from December 1, 2019 through August 31, 2022 will be used to evaluate the IntelliCare service. All CCT patients who are 18 or older, and have a smartphone will be offered enrollment.
- Conditions
- Depression
- Being tested
- IntelliCare, Treatment as Usual (TAU)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliCareDevice
IntelliCare provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.
Treatment as Usual (TAU)Behavioural
Treatment as usual in the Rush Collaborative Care service
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service Receives: Behavioral: Treatment as Usual (TAU) |
| IntelliCare | Experimental | Patients will be offered IntelliCare as part of their care in the Rush Collaborative Care service. Patients who agree will download the IntelliCare app, which provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient. Receives: Device: IntelliCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Patient Health Questionnaire-9 (PHQ-9) assessment for depression
Measured: Up to 20 Months
Number of assessments
Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR
Measured: Up to 20 Months
Secondary outcomes (1)
First to last assessment
Time from first to last PHQ-9
Measured: Up to 20 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Dec 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Why it stopped: The recruitment site (Rush University Medical Center Collaborative Care Program) redefined their service objectives such that IntelliCare was no longer a good fit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will utilize a pragmatic, system-wide rollout quality improvement evaluation design. Data from patients in the Rush Collaborative Care service will be used beginning Dec 1, 2019. The first care manager will begin offering IntelliCare as part of the collaborative care service in September, 2020, and one additional care manager will begin offering IntelliCare to patients every 3 months
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Responsible party
- Sponsor
- Investigators
- Carolyn MacIver, Principal investigator, Adaptive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499729
- Sponsor's protocol ID
- R44MH114725
- Status last verified
- Nov 2021
- First submitted
- 27 Jul 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is not current plan to share IPD outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation
- ClinicalTrials.gov ID
- NCT04499729
- Acronym / sponsor ID
- R44MH114725
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment site (Rush University Medical Center Collaborative Care Program) redefined their service objectives such that IntelliCare was no longer a good fit.
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Adaptive Health, IncIndustry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 5 Aug 2020 (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 overarching aim of the proposed project is to conduct a pragmatic, quality improvement evaluation of the IntelliCare Platform for improving processes of care in the Rush Collaborative Care program, and improving patient population depression outcomes, to determine the long-term utility of IntelliCare for Rush.
Detailed description
This study is a pragmatic, system-wide rollout quality improvement evaluation design displayed in Figure 1. The Rush IRB has waived consent for this quality improvement trial. Data from the EHR will be used beginning December 1, 2019. The first care manager (CM) will begin enrolling patients into IntelliCare in September, 2020. Additional CMs will begin using IntelliCare at approximately 3 month intervals. In September 2021, support for IntelliCare from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare Platform.
Patients Data from all patients, aged 18 or older, enrolled collaborative care from December 1, 2019 through August 31, 2022 will be used to evaluate the IntelliCare service. All CCT patients who are 18 or older, and have a smartphone will be offered enrollment.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will utilize a pragmatic, system-wide rollout quality improvement evaluation design. Data from patients in the Rush Collaborative Care service will be used beginning Dec 1, 2019. The first care manager will begin offering IntelliCare as part of the collaborative care service in September, 2020, and one additional care manager will begin offering IntelliCare to patients every 3 months
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service |
| IntelliCare | Experimental | Device: IntelliCarePatients will be offered IntelliCare as part of their care in the Rush Collaborative Care service. Patients who agree will download the IntelliCare app, which provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolled in Rush Collaborative Care service
- Owns a personal smartphone
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| IntelliCareIntelliCare provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient. | Device | IntelliCare |
| Treatment as Usual (TAU)Treatment as usual in the Rush Collaborative Care service | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Depression
Time frame: Up to 20 Months
Patient Health Questionnaire-9 (PHQ-9) assessment for depression
Number of assessments
Time frame: Up to 20 Months
Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR
1 secondary outcome
First to last assessment
Time frame: Up to 20 Months
Results and safety
The study was stopped early (reason given: The recruitment site (Rush University Medical Center Collaborative Care Program) redefined their service objectives such that IntelliCare was no longer a good fit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: Undecided. There is not current plan to share IPD outside the research team.
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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.
Carolyn MacIver principal investigator
Adaptive Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntelliCare and Treatment as Usual (TAU) in people with Depression, run by Adaptive Health, Inc 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 2 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: stopped early, as of the sponsor's last update on 3 Dec 2021. 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?
The study was stopped early (reason given: The recruitment site (Rush University Medical Center Collaborative Care Program) redefined their service objectives such that IntelliCare was no longer a good fit.). Results are not available in the source record.
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?
Depression (time frame: Up to 20 Months). The study lists 2 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 3 Dec 2021.