Trial · NCT05110014
Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety
NCT05110014, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2022-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety. Trials, record NCT05110014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05110014
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety
- NCT number
- NCT05110014
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 23,026 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Depression
- Interventions
- Primary Care Office Visits
- First posted
- 2021-11-05
- Last updated
- 2023-04-13
- Results first posted
- 2022-04-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | 2 months prior to use of intervention | The primary outcome will be the proportion of patients seen in each time period ("pre" vs. "post") who screen positive for depression, fall risk, or intimate partner violence. The "pre" time period will be Days -60 to -1 (the 60 day period before mPATH Launch). Screening positive for depression will be a score of 3 or greater on the Patient Health Questionnaire-2. Screening positive for fall risk will be answering "yes" to having a device to assist with mobility and/or having fallen in the last year. Screening positive for intimate partner violence will be answering yes to any of the health system's three questions about safety in the home. |
| Primary | Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use | 2 months after use of intervention | The primary outcome will be the proportion of patients seen in each time period ("pre" vs. "post") who screen positive for depression, fall risk, or intimate partner violence. The "post" time period will be days 14 to 73 (the 60 day period commencing 2 weeks after mPATH Launch). Screening positive for depression will be a score of 3 or greater on the Patient Health Questionnaire-2. Screening positive for fall risk will be answering "yes" to having a device to assist with mobility and/or having fallen in the last year. Screening positive for intimate partner violence will be answering yes to any of the health system's three questions about safety in the home. |
| Secondary | Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater) | 2 months before and 2 months after using intervention | The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. Screen positive for depression using the PHQ-2 items. PHQ-2 score obtained by adding score for each question (total points). A PHQ-2 score ranges from 0-6. If the score is 3 or greater, major depressive disorder is likely. |
| Secondary | Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14) | 2 months before and 2 months after using intervention | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 score obtained by adding score for each question (total points). Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively. |
| Secondary | Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19) | 2 months before and 2 months after using intervention | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 score obtained by adding score for each question (total points). Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively. |
| Secondary | Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression. | 2 months before and 2 months after using intervention | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 score obtained by adding score for each question (total points). Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively. |
| Secondary | Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices | 2 months before and 2 months after using intervention | This is measured by the screening question on suicide risk on the PHQ-9: "Thoughts that you would be better off dead or of hurting yourself in some way." |
| Secondary | Number of Participants Screening Positive for Fall Risk at Home in All Practices | 2 months before and 2 months after using intervention | Screen positive for fall risk at home. In addition, the outcomes below will be assessed: * Have fallen in last 6 months * Have had a fall with injury |
| Secondary | Number of Participants Screening Positive for Intimate Partner Violence in All Practices | 2 months before and 2 months after using intervention | Screen positive for safety concerns at home. In addition, the outcome below will be assessed: * Report that conflicts turn into fights |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | 2 months prior to use of intervention | Investigators prefer not to identify the practices by types: 1) Investigators do not hypothesize there will be any difference in effect by practice type and naming the clinics by type could make a reader assume investigators were looking for a 'practice-type' effect), and 2) not identifying which practices further protects the confidentiality of the practices. Overall number = 1,067 is the overall number of participants that were positive out of the 12,239 before mPATH intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use | 2 months after use of intervention | Positive screenings for composite outcomes (depression, fall risk, intimate partner violence) were reported in individual medical practices - 3 family medicine and 3 internal medicine practices. The count of participants = 2,102 is the overall number of participants that were positive out of the 10,787 after mPATH intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater) | 2 months before and 2 months after using intervention | The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14) | 2 months before and 2 months after using intervention | The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19) | 2 months before and 2 months after using intervention | The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression. | 2 months before and 2 months after using intervention | The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices | 2 months before and 2 months after using intervention | The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Screening Positive for Fall Risk at Home in All Practices | 2 months before and 2 months after using intervention | The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Screening Positive for Intimate Partner Violence in All Practices | 2 months before and 2 months after using intervention | The number includes the actual number of participants that were analyzed (2 months before and 2 months after the intervention) out of the total of participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | Primary Care Practices | Practice A | 224 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | Primary Care Practices | Practice B | 94 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | Primary Care Practices | Practice C | 55 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | Primary Care Practices | Practice D | 165 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | Primary Care Practices | Practice E | 265 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use | Primary Care Practices | Practice F | 264 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use | Primary Care Office Visits | Practice A | 509 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use | Primary Care Office Visits | Practice B | 463 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use | Primary Care Office Visits | Practice C | 235 | Participants | |
| Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use | Primary Care Office Visits | Practice D | 242 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Before mPATH Launch | 12,239 | |
| Overall Study | STARTED | After mPATH Launch | 10,787 | |
| Overall Study | COMPLETED | Before mPATH Launch | 12,239 | |
| Overall Study | COMPLETED | After mPATH Launch | 10,787 | |
| Overall Study | NOT COMPLETED | Before mPATH Launch | 0 | |
| Overall Study | NOT COMPLETED | After mPATH Launch | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Primary Care Office Visits (Pre Intervention) | 0 | 0 |
| Total, all-cause mortality | Primary Care Office Visits (Post Intervention) | 0 | 0 |
| Total, other adverse events | Primary Care Office Visits (Pre Intervention) | 0 | 0 |
| Total, other adverse events | Primary Care Office Visits (Post Intervention) | 0 | 0 |
| Total, serious adverse events | Primary Care Office Visits (Pre Intervention) | 0 | 0 |
| Total, serious adverse events | Primary Care Office Visits (Post Intervention) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA218416 | Effectiveness and Implementation of mPATH-CRC: a Mobile Health System for Colorectal Cancer Screening | MILLER, DAVID P | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL CANCER INSTITUTE | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Primary Care Office Visits (Pre Intervention) vs Primary Care Office Visits (Post Intervention): Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices | Trial comparisons |
| Primary Care Office Visits (Pre Intervention) vs Primary Care Office Visits (Post Intervention): Number of Participants Screening Positive for Fall Risk at Home in All Practices | Trial comparisons |
| Primary Care Office Visits (Pre Intervention) vs Primary Care Office Visits (Post Intervention): Number of Participants Screening Positive for Intimate Partner Violence in All Practices | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05110014
GET https://conductscience.org/api/trials/v1/NCT05110014/results?page=2