Recruiting
Phase 3

MD.2

Sponsor:

Interactive Medical Developments

Code:

NCT00560001

Conditions

Frail Elderly

Medication Errors

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

MD.2 Medication Dispenser

Study Details

Brief summary:

The objective of this study is to quantify the benefits of using the MD.2 on health outcomes.

Conditions

Frail Elderly

Medication Errors

Study ID

NCT00560001

Start date

Jan, 2006

Status verified date

Nov, 2007

Completion date

May, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

A client must:

  • Be coming up for regular review in Case or Medication Management
  • Require medication management services
  • Have two or more doses of medication per day
  • Have someone to fill MD.2
  • Be in independent living (may be assisted living with NO medication management services)
  • Be expected to live through follow-up period of six months
  • Have an active phone line that can be utilized by the MD.2 system.

Exclusion Criteria:

A client cannot have/or be the following:

  • Have someone available to administer medications for every dose
  • Have someone in household who is likely to interfere with MD.2
  • Blind AND deaf
  • Eligible for hospice
  • An MD.2 currently

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: A

Those subjects that receive an MD.2 Medication Dispenser

no intervention: B

Control subjects that do not receive an MD.2 Medication Dispenser, but continue to take their medications utilizing standard care, such as pill boxes, etc.

Interventions

MD.2 Medication Dispenser

For those subjects receiving an MD.2 Medication Dispenser, the machine organizes medications and provides verbal and auditory explicit reminders for individuals to take their medications. At the scheduled time, the patient gets a series of reminders. The patient is then expected to push a single button to dispense a pre-filled medication cup. An automatic record is kept of the subject's medication adherence. Interviewer-administered surveys of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits will be given. Caregivers will complete the Caregiver Burden Interview.

Primary outcome measure

  • The rate of hospitalizations and emergency room visits will be compared between the MD.2 and control clients [ Time Frame: per month (30 client days) over 6 consecutive months ]

Central Contacts and Locations

Central contacts

Karen Farris, Ph.D.

319-384-4516karen-farris@uiowa.edu

Julie Lang, M.S.; M.B.A

319-384-2815julie-lang@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242-1101

Contacts

Julie Lang, M.S.; M.B.A.

319-384-2815julie-lang@uiowa.edu

Principal Investigator:

Karen Farris, Ph.D.

More Information

Sponsor

Interactive Medical Developments

Last update posted

Oct 8, 2009

Last verified

Nov, 2007

Keywords

  • frail elderly
  • medication errors
  • patient compliance & attitudes
  • guideline adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Interactive Medical Developments on 2009-10-08.