Virtual Patient Navigation During a Pandemic
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT06208852
- Status
- Recruiting
Conditions
- Post-partum Depression
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Virtual Navigator Program — OTHERFor the intervention phase of the sub-study, 30 women with persistent PPD symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which we will evaluate satisfaction, feasibility, and target engagement of the intervention after every 10 participants in order to make rapid cycle changes prior to enrolling the next 10 participants. Women will communicate virtually with the PN by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The Primary Navigator (PN) will meet with families at the beginning of the study to review results of depression screens and community mental health (MH) resources. The PN will partner with participants, engage them in the program, and provide ongoing communication with participants and MH clinicians.
Study Details
The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.
Key Dates
- Start date
- Jun 29, 2023
- Status verified
- Jan 2026
- Primary completion
- May 31, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- SCREENING
Arms
- No Intervention: Qualitative phaseThe qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services during the pandemic. This information will be used to adapt an evidence-based patient navigation intervention for virtual use.
- Experimental: Intervention PhaseFor the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.
Primary Outcome Measure
Qualitative: Barriers and facilitators to virtual and in-person mental health services [ Time Frame: Baseline ]
Central Contacts
- James Guevara, MD, MPH215-590-1130
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 |