NCT04891224

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

Completed NA Results posted Last updated 24 March 2025

What this trial tests

NA trial testing Pathway Platform mobile app in Major Depressive Disorder in 89 participants. Completed in 30 January 2023.

Timeline

19 February 2021

Primary endpoint
30 January 2023

30 January 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	89
Start date	19 February 2021
Primary completion	30 January 2023
Estimated completion	30 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Pathway Platform mobile app

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients Who Completed Patient Health Questionnaire Primary · 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.

Group	Value	95% CI
Pre-Implementation Cohort	35
Pathway Participants	49

Process Outcome: Measurement-based Care Secondary · Baseline to 6 months post-implementation of the Pathway app

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.

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	38
Pathway Participants (N=89)	40

Process Outcome: Referrals to Behavioral Health Secondary · Baseline to 6 months post-implementation of the Pathway app

The proportion of patients with at least one referral will be compared.

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	21
Pathway Participants (N=89)	8

Process Outcome: Total Number of Hospitalized Participants During Follow up Period Secondary · 6 months prior to and 6 months post-implementation of the Pathway Platform app.

The number who receive follow-up within 7 days of discharge and within 30 days of discharge.

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	19
Pathway Participants (N=89)	23

Process Outcome: Follow-up After Emergency Department Visit for Mental Illness Secondary · Baseline to 6 months post-implementation of the Pathway app

The proportion of adults who receive follow-up within 7 days of discharge and within 30 days of emergency department visit.

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	3
Pathway Participants (N=89)	0

Process Outcome: Healthcare Resource Utilization, Hospital Admissions Secondary · Baseline to 6 months post-implementation of the Pathway app

The number of hospital admissions among patients receiving care at a clinic participating in this study.

Hospitalizations

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	19
Pathway Participants (N=89)	23

Behavioral health related hospitalization

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	4
Pathway Participants (N=89)	0

Process Outcome: Number of Behavioral Related Hospitalizations Secondary · 6 months prior to and 6 months post-implementation of the Pathway Platform app.

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	4
Pathway Participants (N=89)	0

Process Outcome: Healthcare Resource Utilization, Emergency Room Admissions Secondary · Baseline to 6 months post-implementation of the Pathway app

The number of emergency room admissions among patients receiving care at a clinic participating in this study.

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	11
Pathway Participants (N=89)	5

Process Outcome: Healthcare Resource Utilization, Outpatient Visits Secondary · 6 months prior to and 6 months post-implementation of the Pathway Platform app.

The number of outpatient encounters among patients receiving care at a clinic participating in this study.

Number of ED Visits

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	11
Pathway Participants (N=89)	5

Number of Behavioral Health-Related ED Visits

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	11
Pathway Participants (N=89)	5

Number of Outpatient Visits

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	216
Pathway Participants (N=89)	243

Patient Health Questionnaire-9 [PHQ-9] Score Secondary · Baseline to 6 months post-implementation of the Pathway app

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.

PHQ-9 Median Score: Baseline

Group	Value	95% CI
Pre-Implementation Cohort	14.5	11.0 – 27.0
Pathway Participants	12	9.0 – 17.0

3-months

Group	Value	95% CI
Pre-Implementation Cohort	11.0	8.5 – 12.5
Pathway Participants	8.5	3.0 – 15.0

6-months

Group	Value	95% CI
Pre-Implementation Cohort	17.0	14.5 – 20.0
Pathway Participants	6.5	3.0 – 12.5

Patient Health Questionnaire-9 [PHQ-9] Score Reduction Secondary · Baseline to 6 months post-implementation of the Pathway app

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.

Group	Value	95% CI
Pre-Implementation Cohort (N=90)	2
Pathway Participants (N=89)	7

Patient Reported Outcomes: Patient Activation Measure-13 [PAM-13] Secondary · Baseline and 6-month post-Pathway app use

This tool consists of 13 statements used to describe one's health. Patients rate each statement on a likert scale from Disagree Strongly (1) to Agree Strongly (4). Sum scores are categorized into levels of activation with higher scores indicating a patient's readiness to take action. The difference between baseline and 6-month follow up will be compared among patients using the Pathway Platform.

Group	Value	95% CI
Pathway Participants (N=89)	4	-5 – 13

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through week 75. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pathway Platform Application Use

Serious: 5/89 (6%)

Deaths: 0/89

Pre-Implementation Cohort Retrospective Control Group Identified From Study Sites.

Serious: 0

Deaths: 0

Serious adverse events (5 terms)

Reaction	System	Pathway Platform Applicati…	Pre-Implementation Cohort …
Attempted Overdose hospitalization	Psychiatric disorders	—	—
Hospitalization for Cholecystectomy	Gastrointestinal disorders	—	—
D & C procedure	Pregnancy, puerperium and perinatal conditions	—	—
Mitral Valve repair	Cardiac disorders	—	—
Dizziness	Ear and labyrinth disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Pathway Platform Applicati…	Pre-Implementation Cohort …
Carpel tunnel surgery	Musculoskeletal and connective tissue disorders	—	—
Scar Repair	Surgical and medical procedures	—	—
L sided chest pain, ED visit	Investigations	—	—
Abdominal pain/Ovarian cyst rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Observational hospitalization for abnormal vaginal bleeding	Reproductive system and breast disorders	—	—
L Breast Mass Excision	Reproductive system and breast disorders	—	—
Laparoscopic Lysis of Adhesions (renal)	Surgical and medical procedures	—	—
ED visit Anxiety	General disorders	—	—
ED Visit Cellulitis R hand	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Attempted Overdose hospitalization, Hospitalization for Cholecystectomy, D & C procedure, Mitral Valve repair, Dizziness.

Data from ClinicalTrials.gov NCT04891224 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile App to Enhance Patient Activation and Patient-Provider Communication in Major Depressive Disorder Management: Collaborative, Randomized Controlled Pilot Study.
   McCue M, Blair C, Fehnert B, King J, et al · · 2022 · cited 12× · PMID 36301599 · DOI 10.2196/34923
2. User-Centered Design of a Digitally Enabled Care Pathway in a Large Health System: Qualitative Interview Study.
   McCue M, Khatib R, Khatib R, Kabir C, et al · · 2023 · cited 3× · PMID 37494099 · DOI 10.2196/42768
3. 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.
   Khatib R, Khatib R, McCue M, Blair C, et al · · 2023 · cited 3× · PMID 37351941 · DOI 10.2196/43788