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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 is a Phase 1 study that has completed, run by Arizona State University. The registered enrollment target is 414 participants.

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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

Interventions

  • OTHER MD2 machine and nurse care coordination
  • OTHER Medplanner and Nurse Care Coordination

Trial Details

FieldValue
Enrollment Target 414 participants
Start Date 2006-05
Est. Completion 2010-05
Phase Phase 1

Sponsor

Arizona State University

187 total trials

What the Registry Record Tells You About NCT01321853

The ClinicalTrials.gov registry entry for NCT01321853 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 414 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which MD2 machine and nurse care coordination is the first listed.

NCT01321853 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.