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NCT01321853 · ClinicalTrials.gov registry record · Phase 1
Home Care Medication Management Program for the Frail Elderly
A Phase 1 study, sponsored by Arizona State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 414
- Enrollment target
NCT01321853: Completed Phase 1 study, sponsored by Arizona State University.
NCT01321853 is a Phase 1 study that has completed, run by Arizona State University. The registered enrollment target is 414 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (590% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01321853, a Phase 1 study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 414 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year period. The investigators propose a longitudinal three group repeated measures design, enrolling, and randomly assigning, clients who are discharged from a home health care agency with documented problems in medication management. One group will receive the MD.2 medication dispensing device and nurse coordination, the second group will receive a Medplanner: a simple box that has separate compartments for individual medication times over the course of a week plus nurse coordination, and the final group will receive Usual Care. The study hypotheses are the following: H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Medplanner Group. H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Usual Care Group. H3: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the MD.2 Group as compared to the Medplanner Group. H4: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the Medplanner Group as compared to the Usual Care Group. H5: The nursing home admission rate will be significantly lower for the MD.2 Group as compared to the Medplanner Group. H6: The nursing home admission rate will be significantly lower for the Medplanner Group as compared to the Usual Care Group. H7: The total cost of care
Primary Outcome
The Geriatric Depression Scale (GDS) was developed to identify depression in older adults. The original GDS was 30 questions, however, fifteen- and five-question versions also exist. When tested on the oldest old in the community, the 15-item scale was demonstrated to have favorable reliability and validity results. Impaired cognitive function (MMSE \< 28) reduced the tool's specificity, but sensitivity was not affected by lower MMSE scores. The tool is scored into depression categories of "none
Interventions
- OTHER MD2 machine and nurse care coordination
- OTHER Medplanner and Nurse Care Coordination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT01321853 record still lists
NCT01321853 is an interventional study that assigns participants to a tested intervention. The registered 414 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (590% higher).
The record links to 0 conditions, and to 2 interventions - of which MD2 machine and nurse care coordination is the first listed.
NCT01321853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01321853 about?
NCT01321853 is a clinical study titled "Home Care Medication Management Program for the Frail Elderly". The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year ...
What is the current status of trial NCT01321853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 414 participants. The study started on 2006-05. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01321853?
The interventions under investigation include: MD2 machine and nurse care coordination (OTHER), Medplanner and Nurse Care Coordination (OTHER).
Who is sponsoring clinical trial NCT01321853?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01321853's enrollment target sits among peer trials
414 71st of 2000 higher than 1,929 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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