DepressionNCT05110014

Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety

A study testing Primary Care Office Visits in people with Depression, 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

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Trial summary

This is a sub-study for data analysis of data collected as part of the larger randomized controlled trial "Effectiveness and Implementation of mPATH-CRC" (NCT03843957) to determine if self-administered screening with an iPad increases the detection of patients with depression, falls, and intimate partner violence. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: Primary Care Office Visits
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23,026 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2019to 27 Feb 2020
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

Age 18 or older
Completed a provider visit at the study clinic during the 60 days prior to the clinic launching the mPATH program (the "pre" time period), or completed a provider visit at the study clinic during days 14 - 73 after the launch of mPATH (the "post" time period)
Have a preferred language of English or Spanish

Who cannot join

Requiring a language interpreter for a language other than Spanish

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Substudy of Protocol NCT03843957: Effect of mPATH on Screening for Depression, Fall Risk, and Safety

Read the detailed description

As part of the parent study (NCT0343957), investigators developed an iPad program called mPATH that patients use at their primary care clinician's office to encourage colorectal cancer screening. To encourage practices to use mPATH with every patient, the investigators included in the program the health system's required screening items for depression, fall risk, and intimate partner violence, thereby offloading this routine task from clinical staff. It is possible that mPATH will increase detection of depression, fall risk, and intimate partner violence because: 1) mPATH systematically asks these screening items of all patients, and 2) patients may feel more comfortable answering these items on an iPad survey than during an in-person interview.

To determine the effect of mPATH on the performance of this screening, investigators will examine a limited use dataset comparing the 2 months before a clinic started using mPATH to the 2 months after the clinic began using mPATH. Because clinics may need some time to fully adopt mPATH, investigators will exclude the first two weeks following the launch of mPATH.

Conditions: Depression
Being tested: Primary Care Office Visits
Keywords: Fall risk, Intimate partner violence
Medical subject headings: Depression

What participants receive

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

Primary Care Office VisitsOther
mPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence

Study groups in NCT05110014
Study group	Role	What they receive
Primary Care Office Visits	Other	The limited use dataset will contain the following data elements for each completed patient visit: * Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date) * Clinic (designated by a unique study clinic identifier) * Type of visit completed (for example, new patient visit, return patient visit, annual exam) * Patient age * Patient gender * Patient race/ethnicity * Patient primary insurance * Nursing staff who roomed the patient (designated by a unique study identifier) * Whether patient used mPATH-CheckIn program (Y/N) * Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N) * Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N) * Whether patient has an antidepressant medication listed in the active medication list ( (Y/N) * Results of depression screening items * Results of fall risk screening items * Results of safety at home screening items Receives: Other: Primary Care Office Visits

What is being measured

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

Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
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.
Measured: 2 months prior to use of intervention
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
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.
Measured: 2 months after use of intervention

Secondary outcomes (7)

Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)
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.
Measured: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)
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.
Measured: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)
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.
Measured: 2 months before and 2 months after using intervention
Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression.
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.
Measured: 2 months before and 2 months after using intervention
Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices
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."
Measured: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Fall Risk at Home in All Practices
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
Measured: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Intimate Partner Violence in All Practices
Screen positive for safety concerns at home. In addition, the outcome below will be assessed:
- Report that conflicts turn into fights
Measured: 2 months before and 2 months after using intervention

Timeline

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

24 Jun 201927 Feb 2020

First posted5 Nov 2021
Study start24 Jun 2019
Primary completion27 Feb 2020
Study completion27 Feb 2020

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.
Other trials for DepressionStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23,026 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05110014
Sponsor's protocol ID: IRB00048919.sub
Other IDs: R01CA218416
Status last verified: Feb 2022
First submitted: 26 Oct 2021
Last updated: 13 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Substudy of Protocol NCT03843957: Effect of mPATH on Screening for Depression, Fall Risk, and Safety
ClinicalTrials.gov ID: NCT05110014
Acronym / sponsor ID: IRB00048919.sub
Conditions: Depression
Keywords: Fall risk, Intimate partner violence
Study type: Interventional
Recruitment status: Completed
Enrolment: 23,026 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 24 Jun 2019 (actual)
Primary completion: 27 Feb 2020 (actual)
Study completion: 27 Feb 2020 (actual)
First posted: 5 Nov 2021 (actual)
Results: Posted 5 Apr 2022

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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Primary Care Office Visits	Other	Other: Primary Care Office VisitsThe limited use dataset will contain the following data elements for each completed patient visit: * Date of clinic visit (where each date is indicated by a number relative to the clinic's Launch Date) * Clinic (designated by a unique study clinic identifier) * Type of visit completed (for example, new patient visit, return patient visit, annual exam) * Patient age * Patient gender * Patient race/ethnicity * Patient primary insurance * Nursing staff who roomed the patient (designated by a unique study identifier) * Whether patient used mPATH-CheckIn program (Y/N) * Whether nursing staff used mPATH Nursing Module to transmit mPATH data to electronic health record (Y/N) * Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N) * Whether patient has an antidepressant medication listed in the active medication list ( (Y/N) * Results of depression screening items * Results of fall risk screening items * Results of safety at home screening items

Who may qualify

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

Key inclusion criteria (3 listed)

Age 18 or older
Completed a provider visit at the study clinic during the 60 days prior to the clinic launching the mPATH program (the "pre" time period), or completed a provider visit at the study clinic during days 14 - 73 after the launch of mPATH (the "post" time period)
Have a preferred language of English or Spanish

Key exclusion criteria (1 listed)

Requiring a language interpreter for a language other than Spanish

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
Primary Care Office VisitsmPATH iPad program that contains self-administered screening items for depression, fall risk, and intimate partner violence	Other	Primary Care Office Visits

Primary outcome

Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use
Time frame: 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.
Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use
Time frame: 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.

7 secondary outcomes

Number of Participants Screening Positive for Depression Using Patient Health Questionnaires (PHQ-2 Score of 3 or Greater)
Time frame: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Moderately Severe or Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 14)
Time frame: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Severe Depression Using Patient Health Questionnaires (PHQ-9 Score Greater Than 19)
Time frame: 2 months before and 2 months after using intervention
Number of Participants With a Patient Health Questionnaires (PHQ-9 Score Greater Than 14) and Not Currently Taking a Medication for Depression.
Time frame: 2 months before and 2 months after using intervention
Number of Participants Who Report Thoughts of Self Harm - Patient Health Questionnaire (PHQ-9) in All Practices
Time frame: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Fall Risk at Home in All Practices
Time frame: 2 months before and 2 months after using intervention
Number of Participants Screening Positive for Intimate Partner Violence in All Practices
Time frame: 2 months before and 2 months after using intervention

Results and safety

Results posted to the registry on 5 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Before mPATH Launch	12,239	12,239
After mPATH Launch	10,787	10,787

Primary outcome: Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use

Time frame: 2 months prior to use of intervention. Count of participants. Unit: Participants

Measure	Primary Care Practices n = 12239
Practice A	224
Practice B	94
Practice C	55
Practice D	165
Practice E	265
Practice F	264

Population analysed: 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.

Primary outcome: Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Post mPATH Use

Time frame: 2 months after use of intervention. Count of participants. Unit: Participants

Measure	Primary Care Office Visits n = 10787
Practice A	509
Practice B	463
Practice C	235
Practice D	242
Practice E	418
Practice F	235

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Care Office Visits (Pre Intervention)	0 of 0	0 of 0	0
Primary Care Office Visits (Post Intervention)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Miller, MD, MS principal investigator

Wake Forest Baptist Health Sciences

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

Questions about this trial

What is this clinical trial studying?

A study testing Primary Care Office Visits in people with Depression, 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 3 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: finished, as of the sponsor's last update on 13 Apr 2023. 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 5 Apr 2022). 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?

Number of Participants Screening Positive for Depression, Fall Risk or Intimate Partner Violence - Pre mPATH Use (time frame: 2 months prior to use of intervention). 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?

On the ClinicalTrials.gov record for NCT05110014.

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 13 Apr 2023.