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NCT01221090 · ClinicalTrials.gov registry record · Phase 4
Diabetes Self-Management Models to Reduce Health Disparities
A Phase 4 study, sponsored by Scott and White Hospital & Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 376
- Enrollment target
NCT01221090 is a Phase 4 study that has completed, run by Scott and White Hospital & Clinic. The registered enrollment target is 376 participants.
The verdict
NCT01221090, a Phase 4 study, has completed, sponsored by Scott and White Hospital & Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 376 participants
- Enrollment target
Study Summary
To evaluate the effectiveness of two different diabetes self-management approaches (Personal Digital Assistant-based intervention \& Chronic Disease Self-Management Program) to reduce health disparities in minority, rural residents, and other underserved populations with type 2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with T2DM will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes, which persist even when controlling for age, gender, obesity, and insurance status; 2) Patients with T2DM who reside in more rural areas will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes as compared to more urban counterparts, controlling for age, gender, race/ethnicity, obesity, and insurance status; 3) The introduction of CSDMP and HIT protocols will improve diabetes-related self management behaviors, reduce HBA1c values, and increase quality of life in persons with T2DM as compared to controls. A combined intervention approach will result in the greatest reductions; 4) Health improvements following the introduction of CDSMP, HIT or CDSMP/HIT protocols in persons with T2DM compared to controls will be more marked in racial/ethnic minority patients and those patients residing in rural areas; 5) The introduction of self-management interventions will be cost-effective in reducing HbA1c values over time, and associated health care utilization including overall reduction in ER and acute care hospital admissions; 6) Although there is little prior research in this area to guide specific hypotheses, we hypothesize that, overall, there will be no significant cost-effective differential in CDSMP as compared to HIT approaches, although the cost-effective ratio may be stronger in particular subpopulations. The combined approach will have higher costs, but is also anticipated to have a higher cost-benefit ratio for minority populations; 7) The
Interventions
- BEHAVIORAL PDA
- BEHAVIORAL CDSMP
- BEHAVIORAL PDA/CDSMP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01221090
The ClinicalTrials.gov registry entry for NCT01221090 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 376 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scott and White Hospital & Clinic, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which PDA is the first listed.
NCT01221090 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01221090 about?
NCT01221090 is a clinical study titled "Diabetes Self-Management Models to Reduce Health Disparities". To evaluate the effectiveness of two different diabetes self-management approaches (Personal Digital Assistant-based intervention \& Chronic Disease Self-Management Program) to reduce health disparities in minority, rural residents, and other underserved populations with type 2 diabetes in Central T...
What is the current status of trial NCT01221090?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 376 participants. The study started on 2009-01. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01221090?
The interventions under investigation include: PDA (BEHAVIORAL), CDSMP (BEHAVIORAL), PDA/CDSMP (BEHAVIORAL).
Who is sponsoring clinical trial NCT01221090?
This trial is sponsored by Scott and White Hospital & Clinic, which has 9 total clinical trials registered on ClinicalTrials.gov.
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