Major Depressive DisorderNCT04891224

Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression

A study testing Pathway Platform mobile app in people with Major Depressive Disorder, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Pathway Platform mobile app
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 19 Feb 2021to 30 Jan 2023
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
Recently prescribed monotherapy antidepressant medication (defined as new start, medication switch, or dose change in the past 3 months.)
Patients with inadequate response or tolerability concerns determined based on A PHQ-2 score of 3 or greater or a PHQ-9 score of 5 or more, recorded in medical records in the past 6 weeks or during screening,
Able and willing to provide informed consent
Able to use the Pathway Platform based on clinician's judgment, e.g. owns an iPhone version 5 or later or smartphones with Android operating systems, have an active data plan or regular WiFi access

Who cannot join

Missing PHQ-2 score in the past 6 weeks and/or unable to perform PHQ-2 at index visit
Diagnosis with bipolar depression, schizophrenia, and/or schizoaffective disorder
Patient no longer under primary care for depression and has transitioned to a psychiatric care team (i.e., Psychiatrist, Advance Practice Psychiatric Nurse, Psychiatric Nurse Practitioner, Psychiatric Physician Assistant).
Lack of functional English literacy (indicated by primary language in electronic medical record).

Trial locations and contacts

1 site in 1 country.

United States1 site

Advocate Christ Medical Center
Oak Lawn, Illinois, 60453

Other trials in United States

About this study

Official title: Implementation and Evaluation of the Pathway Platform: A Digitally Enabled Care Pathway to Improve Depression Key Performance Indicators and Patient Outcomes in Primary Care Clinics

This study was conducted to understand the use of a mobile app (titled Pathway) to help patients track depression symptoms, medications, side effects, and goals in addition to the usual care with their doctor. Investigators compared the effect of the app over 6 months and examine whether the app can increase engagement between patients and their doctor and help in the management of illnesses as patients started a new treatment for depression. The investigators hoped that using an app to facilitate management of depression symptoms, medication use, and side effects help patients and their providers understand their response to medications and lead to better response and improvements in depression.

Read the detailed description

A pre- and post- study design was utilized to assess the impact of implementing the Pathway Platform in the primary care setting. The Pathway Platform consists of a mobile app for patients and a care team interface that can be accessed through Epic (electronic medical record system). Eight primary care sites were identified to participate in the study. Care team members involved in depression management received education on evidence-based clinical practices for depression care, such as measurement-based care practices and shared- decision making. Clinics with behavioral resources also received additional education on behavioral health integration. Training on how to onboard patients to use the Pathway Platform and utilize electronic medical records to view data collected in the Pathway Platform was also provided. Study outcomes identified in this protocol are described among patients enrolled in the Pathway Platform (post-implementation cohort) as well as a similar group of patients from the same participating clinics prior to study implantation (pre-implantation cohort). Implementation success was evaluated by comparing study outcomes among these two cohorts. The primary outcome is PHQ-9 utilization over six months are compared between the pre- and post- implementation cohorts. Additional process measures compared include; shared-decision making, medication adjustments, referrals to behavioral health, primary care follow-up post hospitalizations, and depression remission and response. Data collected in the Pathway Platform is also used to explore pre-defined patient outcomes.

Conditions: Major Depressive Disorder
Being tested: Pathway Platform mobile app
Keywords: PHQ-9, Shared decision making
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pathway Platform mobile appOther
The pathway platform intervention involves 3 components: 1. The patient facing app which will: a) Gather health information related to depression management and patient-Provider engagement. b) Clinical data collection; PHQ-9, WHO-5, PDQ-D-5, medication adherence and side effects, goal setting and goal tracking. c) Research data; Patient Activation Measure -13[PAM-13], CollaboRATE, and Work and Social Adjustment Scale [WSAS]. 2. Electronic Medical Record Integration - a) Data collected in the app is accessible to care team in real time. b) Provide a longitudinal summary to assist in decision making and depression management. 3. Educational Scaffolding - a) Training program describing how the Pathway Platform can support care team members in clinical processes related to measurement-based care and shared-decision making. b) Includes ongoing feedback with up to three audit cycles.

Study groups in NCT04891224
Study group	Role	What they receive
Pathway Platform application use	Other	Study participants will download the Pathway app to their mobile device. This app will gather patient health data, present standardized questionnaires and research data collection tools. Subject responses will be visible to their provider via interface with the electronic medical record. Receives: Other: Pathway Platform mobile app

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Who Completed Patient Health Questionnaire
Proportion of patients who have at least 2 Patient Health Questionnaire (PHQ) scores documented in their medical record over the 6 month study period will be compared between pre- and post- Pathway app implementation to determine if there is a change in adherence to measurement based care practices following the implementation of the Pathway Platform in a primary care setting.
Measured: Baseline to 6 months post-implementation of the Pathway app

Secondary outcomes (12)

Process Outcome: Measurement-based Care
The proportion of patients reflecting measurement-based care informed major depression disorder treatment adjustments in their charts, defined as at lease one medication dose change, switch or add on medication.
Measured: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Shared-decision Making
The proportion of patients reflecting shared-decision making using the OPTION12 Tool framework.
Measured: 6 months prior to and 6 months post-implementation of the Pathway Platform app
Process Outcome: Referrals to Behavioral Health
The proportion of patients with at least one referral will be compared.
Measured: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Total Number of Hospitalized Participants During Follow up Period
The number who receive follow-up within 7 days of discharge and within 30 days of discharge.
Measured: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Process Outcome: Follow-up After Emergency Department Visit for Mental Illness
The proportion of adults who receive follow-up within 7 days of discharge and within 30 days of emergency department visit.
Measured: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Healthcare Resource Utilization, Hospital Admissions
The number of hospital admissions among patients receiving care at a clinic participating in this study.
Measured: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Number of Behavioral Related Hospitalizations
Measured: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions
The number of emergency room admissions among patients receiving care at a clinic participating in this study.
Measured: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Healthcare Resource Utilization, Outpatient Visits
The number of outpatient encounters among patients receiving care at a clinic participating in this study.
Measured: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Process Outcome: Primary Care Physician (PCP) Visits
The costs associated with health care services among patients receiving care at a clinic participating in this study. Costs will be calculated using USA national average costs for inpatient and outpatient visits.
Measured: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Patient Health Questionnaire-9 [PHQ-9] Score
Median Patient Health Questionnaire-9 [PHQ-9] scores <=5 at the end of the study period. Scores from this nine item questionnaire can range from 0-27. Higher scores indicate greater severity of depression. The last measurement available will be used to calculate remission. For participants 'Baseline' refers to the PHQ9 value the patient entered on the day they downloaded the app. For pre-implementation controls 'Baseline' refers to the PHQ value from the EHR on the qualifying visit.
Measured: Baseline to 6 months post-implementation of the Pathway app
Patient Health Questionnaire-9 [PHQ-9] Score Reduction
Number of patients with a 50 percent or greater reduction in PHQ-9 scores. Scores from this nine item questionnaire can range from 0-27. Higher scores indicate greater severity of depression. A 50 percent reduction in score reflects significant improvement in depression. The first and last scores available during the study period will be used to calculate response.
Measured: Baseline to 6 months post-implementation of the Pathway app

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 202130 Jan 2023

First posted18 May 2021
Study start19 Feb 2021
Primary completion30 Jan 2023
Study completion30 Jan 2023

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.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: This study will used a pre- post- study design to assess the impact of implementing the Pathway Platform in the primary care setting. Clinic performance and select patient outcomes are compared before and after implementation. Additional patient outcomes are assessed after implementation among patients using the Pathway Platform.
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04891224
Sponsor's protocol ID: 9050020
Status last verified: May 2024
First submitted: 9 Mar 2021
Last updated: 24 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Lam RW, Lamy FX, Danchenko N, Yarlas A, White MK, Rive B, Saragoussi D. Psychometric validation of the Perceived Deficits Questionnaire-Depression (PDQ-D) instrument in US and UK respondents with major depressive disorder. Neuropsychiatr Dis Treat. 2018 Oct 29;14:2861-2877. doi: 10.2147/NDT.S175188. eCollection 2018.
PubMed 30464471
Krieger T, Zimmermann J, Huffziger S, Ubl B, Diener C, Kuehner C, Grosse Holtforth M. Measuring depression with a well-being index: further evidence for the validity of the WHO Well-Being Index (WHO-5) as a measure of the severity of depression. J Affect Disord. 2014 Mar;156:240-4. doi: 10.1016/j.jad.2013.12.015. Epub 2013 Dec 25.
PubMed 24412323
Chen X, Hu N, Wang Y, Gao X. Validation of a brain-computer interface version of the digit symbol substitution test in healthy subjects. Comput Biol Med. 2020 May;120:103729. doi: 10.1016/j.compbiomed.2020.103729. Epub 2020 Mar 25.
PubMed 32250858
Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
PubMed 20550019
McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, Manber R. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000 Jan-Mar;26(1):25-40. doi: 10.1080/009262300278623.
PubMed 10693114
Vortel MA, Adam S, Port-Thompson AV, Friedman JM, Grande SW, Birch PH. Comparing the ability of OPTION(12) and OPTION(5) to assess shared decision-making in genetic counselling. Patient Educ Couns. 2016 Oct;99(10):1717-23. doi: 10.1016/j.pec.2016.03.024. Epub 2016 Mar 24.
PubMed 27085518
Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
PubMed 16336556
Forcino RC, Barr PJ, O'Malley AJ, Arend R, Castaldo MG, Ozanne EM, Percac-Lima S, Stults CD, Tai-Seale M, Thompson R, Elwyn G. Using CollaboRATE, a brief patient-reported measure of shared decision making: Results from three clinical settings in the United States. Health Expect. 2018 Feb;21(1):82-89. doi: 10.1111/hex.12588. Epub 2017 Jul 5.
PubMed 28678426
Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645
Khatib R, Blair C, McCue M, Fehnert B, King J, Zaki L, Chrones L, Roy A, Martin ML, Donovan R, Ingle M, Guzman I, Kemp DE. Real-World Implementation and Evaluation of a Digitally Enabled Care Pathway to Improve Depression Management in Primary Care: Controlled Pre-Post Analysis of the Pathway Platform. JMIR Form Res. 2026 Aug 6;10:e93024. doi: 10.2196/93024.
PubMed 42562382
Khatib R, McCue M, Blair C, Roy A, Franco J, Fehnert B, King J, Sarkey S, Chrones L, Martin M, Kabir C, Kemp DE. Design and Implementation of a Digitally Enabled Care Pathway to Improve Management of Depression in a Large Health Care System: Protocol for the Implementation of a Patient Care Platform. JMIR Res Protoc. 2023 Jun 23;12:e43788. doi: 10.2196/43788.
PubMed 37351941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation and Evaluation of the Pathway Platform: A Digitally Enabled Care Pathway to Improve Depression Key Performance Indicators and Patient Outcomes in Primary Care Clinics
ClinicalTrials.gov ID: NCT04891224
Acronym / sponsor ID: 9050020
Conditions: Major Depressive Disorder
Keywords: PHQ-9, Shared decision making
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: Takeda, Lundbeck LLC
Study start: 19 Feb 2021 (actual)
Primary completion: 30 Jan 2023 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 18 May 2021 (actual)
Results: Posted 24 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This study will used a pre- post- study design to assess the impact of implementing the Pathway Platform in the primary care setting. Clinic performance and select patient outcomes are compared before and after implementation. Additional patient outcomes are assessed after implementation among patients using the Pathway Platform.

Arm	Type	Receives
Pathway Platform application use	Other	Other: Pathway Platform mobile appStudy participants will download the Pathway app to their mobile device. This app will gather patient health data, present standardized questionnaires and research data collection tools. Subject responses will be visible to their provider via interface with the electronic medical record.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
Recently prescribed monotherapy antidepressant medication (defined as new start, medication switch, or dose change in the past 3 months.)
Patients with inadequate response or tolerability concerns determined based on A PHQ-2 score of 3 or greater or a PHQ-9 score of 5 or more, recorded in medical records in the past 6 weeks or during screening,
Able and willing to provide informed consent
Able to use the Pathway Platform based on clinician's judgment, e.g. owns an iPhone version 5 or later or smartphones with Android operating systems, have an active data plan or regular WiFi access

Key exclusion criteria (4 listed)

Missing PHQ-2 score in the past 6 weeks and/or unable to perform PHQ-2 at index visit
Diagnosis with bipolar depression, schizophrenia, and/or schizoaffective disorder
Patient no longer under primary care for depression and has transitioned to a psychiatric care team (i.e., Psychiatrist, Advance Practice Psychiatric Nurse, Psychiatric Nurse Practitioner, Psychiatric Physician Assistant).
Lack of functional English literacy (indicated by primary language in electronic medical record).

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
Pathway Platform mobile appThe pathway platform intervention involves 3 components: 1. The patient facing app which will: a) Gather health information related to depression management and patient-Provider engagement. b) Clinical data collection; PHQ-9, WHO-5, PDQ-D-5, medication adherence and side effects, goal setting and goal tracking. c) Research data; Patient Activation Measure -13[PAM-13], CollaboRATE, and Work and Social Adjustment Scale [WSAS]. 2. Electronic Medical Record Integration - a) Data collected in the app is accessible to care team in real time. b) Provide a longitudinal summary to assist in decision making and depression management. 3. Educational Scaffolding - a) Training program describing how the Pathway Platform can support care team members in clinical processes related to measurement-based care and shared-decision making. b) Includes ongoing feedback with up to three audit cycles.	Other	Pathway Platform application use

Primary outcome

Proportion of Patients Who Completed Patient Health Questionnaire
Time frame: Baseline to 6 months post-implementation of the Pathway app
Proportion of patients who have at least 2 Patient Health Questionnaire (PHQ) scores documented in their medical record over the 6 month study period will be compared between pre- and post- Pathway app implementation to determine if there is a change in adherence to measurement based care practices following the implementation of the Pathway Platform in a primary care setting.

12 secondary outcomes

Process Outcome: Measurement-based Care
Time frame: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Shared-decision Making
Time frame: 6 months prior to and 6 months post-implementation of the Pathway Platform app
Process Outcome: Referrals to Behavioral Health
Time frame: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Total Number of Hospitalized Participants During Follow up Period
Time frame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Process Outcome: Follow-up After Emergency Department Visit for Mental Illness
Time frame: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Healthcare Resource Utilization, Hospital Admissions
Time frame: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Number of Behavioral Related Hospitalizations
Time frame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions
Time frame: Baseline to 6 months post-implementation of the Pathway app
Process Outcome: Healthcare Resource Utilization, Outpatient Visits
Time frame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Process Outcome: Primary Care Physician (PCP) Visits
Time frame: 6 months prior to and 6 months post-implementation of the Pathway Platform app.
Patient Health Questionnaire-9 [PHQ-9] Score
Time frame: Baseline to 6 months post-implementation of the Pathway app
Patient Health Questionnaire-9 [PHQ-9] Score Reduction
Time frame: Baseline to 6 months post-implementation of the Pathway app

Results and safety

Results posted to the registry on 24 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-Implementation Cohort	90	90
Pathway Participants	89	89

Primary outcome: Proportion of Patients Who Completed Patient Health Questionnaire

Time frame: Baseline to 6 months post-implementation of the Pathway app. Number. Unit: participants

Measure	Pre-Implementation Cohort n = 90	Pathway Participants n = 89
Value	35	49

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through week 75. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pathway Platform Application Use	5 of 89 (5.6%)	10 of 89 (11.2%)	0 of 89
Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites.	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Small sample size and high attrition rates in both cohorts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Background: PubMed 30464471Lam RW, Lamy FX, Danchenko N, Yarlas A, White MK, Rive B, Saragoussi D. Psychometric validation of the Perceived Deficits Questionnaire-Depression (PDQ-D) instrument in US and UK respondents with major depressive disorder. Neuropsychiatr Dis Treat. 2018 Oct 29;14:2861-2877. doi: 10.2147/NDT.S175188. eCollection 2018.
Background: PubMed 24412323Krieger T, Zimmermann J, Huffziger S, Ubl B, Diener C, Kuehner C, Grosse Holtforth M. Measuring depression with a well-being index: further evidence for the validity of the WHO Well-Being Index (WHO-5) as a measure of the severity of depression. J Affect Disord. 2014 Mar;156:240-4. doi: 10.1016/j.jad.2013.12.015. Epub 2013 Dec 25.
Background: PubMed 32250858Chen X, Hu N, Wang Y, Gao X. Validation of a brain-computer interface version of the digit symbol substitution test in healthy subjects. Comput Biol Med. 2020 May;120:103729. doi: 10.1016/j.compbiomed.2020.103729. Epub 2020 Mar 25.
Background: PubMed 20550019Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
Background: PubMed 10693114McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, Manber R. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000 Jan-Mar;26(1):25-40. doi: 10.1080/009262300278623.
Background: PubMed 27085518Vortel MA, Adam S, Port-Thompson AV, Friedman JM, Grande SW, Birch PH. Comparing the ability of OPTION(12) and OPTION(5) to assess shared decision-making in genetic counselling. Patient Educ Couns. 2016 Oct;99(10):1717-23. doi: 10.1016/j.pec.2016.03.024. Epub 2016 Mar 24.
Background: PubMed 16336556Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
Background: PubMed 28678426Forcino RC, Barr PJ, O'Malley AJ, Arend R, Castaldo MG, Ozanne EM, Percac-Lima S, Stults CD, Tai-Seale M, Thompson R, Elwyn G. Using CollaboRATE, a brief patient-reported measure of shared decision making: Results from three clinical settings in the United States. Health Expect. 2018 Feb;21(1):82-89. doi: 10.1111/hex.12588. Epub 2017 Jul 5.
Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
Derived from this study: PubMed 42562382Khatib R, Blair C, McCue M, Fehnert B, King J, Zaki L, Chrones L, Roy A, Martin ML, Donovan R, Ingle M, Guzman I, Kemp DE. Real-World Implementation and Evaluation of a Digitally Enabled Care Pathway to Improve Depression Management in Primary Care: Controlled Pre-Post Analysis of the Pathway Platform. JMIR Form Res. 2026 Aug 6;10:e93024. doi: 10.2196/93024.
Derived from this study: PubMed 37351941Khatib R, McCue M, Blair C, Roy A, Franco J, Fehnert B, King J, Sarkey S, Chrones L, Martin M, Kabir C, Kemp DE. Design and Implementation of a Digitally Enabled Care Pathway to Improve Management of Depression in a Large Health Care System: Protocol for the Implementation of a Patient Care Platform. JMIR Res Protoc. 2023 Jun 23;12:e43788. doi: 10.2196/43788.
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.

David Kemp, MD principal investigator

Advocate Medical Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pathway Platform mobile app in people with Major Depressive Disorder, run by Wake Forest University Health Sciences 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 5 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 24 Mar 2025. 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 24 Mar 2025). 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?

Proportion of Patients Who Completed Patient Health Questionnaire (time frame: Baseline to 6 months post-implementation of the Pathway app). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04891224, which also lists 12 linked publications.

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 24 Mar 2025.