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

NCT04891224 | Completed Results

• 1 other identifier: 9050020
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

PHQ-9, Shared decision making

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 months post-implementation of the Pathway app

Secondary Outcomes (12)

• Process Outcome: Measurement-based Care

  Baseline to 6 months post-implementation of the Pathway app

• Process Outcome: Shared-decision Making

  6 months prior to and 6 months post-implementation of the Pathway Platform app

• Process Outcome: Referrals to Behavioral Health

  Baseline to 6 months post-implementation of the Pathway app

• Process Outcome: Total Number of Hospitalized Participants During Follow up Period

  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

  Baseline to 6 months post-implementation of the Pathway app

Other Outcomes (7)

• Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13]

  Baseline and 6-month post-Pathway app use

• Patient Reported Outcomes: CollaboRATE

  Baseline, 3 months and 6 months post-Pathway app use.

• Patient Reported Outcomes: Work and Social Adjustment Scale (WSAS)

  Baseline and 6-month post-Pathway app use

Study Arms (1)

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.

Other: Pathway Platform mobile app

Interventions

Pathway Platform mobile app OTHER

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.

Pathway Platform application use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Takeda: collaborator
• Lundbeck LLC: collaborator

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Related Publications (11)

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 30464471 BACKGROUND

• 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.

  PMID: 24412323 BACKGROUND

• 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.

  PMID: 32250858 BACKGROUND

• 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.

  PMID: 20550019 BACKGROUND

• 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.

  PMID: 10693114 BACKGROUND

• 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.

  PMID: 27085518 BACKGROUND

• 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.

  PMID: 16336556 BACKGROUND

• 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.

  PMID: 28678426 BACKGROUND

• 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.

  PMID: 11983645 BACKGROUND

• 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.

  PMID: 37351941 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

Small sample size and high attrition rates in both cohorts.

Results Point of Contact

• Title: Ramona Donovan, Research Project Manager
• Organization: Advocate Health Care

ramona.donovan@aah.org

847-723-5792

Study Officials

• David Kemp, MD

  Advocate Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: May 18, 2021
• Study Start: February 19, 2021
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)