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NCT01188135 · ClinicalTrials.gov registry record · Phase 3
Antidepressant Adherence Via AD_IVR
A Phase 3 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,058
- Enrollment target
NCT01188135 is a Phase 3 study that has completed, run by Kaiser Permanente. The registered enrollment target is 6,058 participants.
The verdict
NCT01188135, a Phase 3 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,058 participants
- Enrollment target
Study Summary
Antidepressants are the most frequently prescribed class of psycho¬tropic medications and the most common treatment for depression and anxiety disorders-yet patient adherence is poor and is widely viewed as contributing to reduced effectiveness. However, traditionally-delivered adherence promotion programs are complex, staff-intensive, and costly-barriers to wider adoption, implementation, and maintenance of these programs in real-world settings. Our aim is to carry out a trial of a low-cost, IT-enabled Antidepressants adherence program, specifically a direct-to-patient, automated telephone interactive voice recognition (IVR) intervention to boost patient Antidepressants persistence. We will conduct a randomized clinical trial enrolling at least 6,000 Kaiser Permanente NW Region health plan members ages 21 to 75, who had recently started on Antidepressants medications for depression and/or anxiety diagnoses. Participants will be randomized one of four arms;1. a no contact control arm, 2. a treatment as usual (TAU) control condition 3. to TAU plus the IVR automated telephone program and 4. a TAU plus the IVR automated telephone program plus receipt of psycho-education materials about antidepression medication use. Recruitment will continue for up to 18 months, with periodic participant-level follow-up assessment for the intervention participants for 40 weeks. The IVR intervention portion of the program will deliver reminder and/or tardy calls timed to projected Antidepressants refill dates. The intervention also optionally offers brief psycho-education, or transfer to a live pharmacist or the Kaiser mail refill pharmacy. The primary outcome will be the Estimated Level of Persistence with Therapy (continued us of Antidepressants medications). This will be based on prescription refill data abstracted from the Kaiser's electronic medical record (EMR). We hypothesize that participants in the IVR + psycho-education materials study arm will have a significantly higher rate
Interventions
- BEHAVIORAL Interactive voice messaging or Interactive voice messaging + psycho ed materials
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,058 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01188135
The ClinicalTrials.gov registry entry for NCT01188135 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 6,058 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Interactive voice messaging or Interactive voice messaging + psycho ed materials is the first listed.
NCT01188135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01188135 about?
NCT01188135 is a clinical study titled "Antidepressant Adherence Via AD_IVR". Antidepressants are the most frequently prescribed class of psycho¬tropic medications and the most common treatment for depression and anxiety disorders-yet patient adherence is poor and is widely viewed as contributing to reduced effectiveness. However, traditionally-delivered adherence promotion p...
What is the current status of trial NCT01188135?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,058 participants. The study started on 2011-02. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01188135?
The interventions under investigation include: Interactive voice messaging or Interactive voice messaging + psycho ed materials (BEHAVIORAL).
Who is sponsoring clinical trial NCT01188135?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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