MD.2 Medication Dispenser Medication Adherence Study

NCT00560001 | Unknown Phase 3 DMC

• 2 other identifiers: PHS 2003-2 FAST TRACK5R42AG021844-02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The rate of hospitalizations and emergency room visits will be compared between the MD.2 and control clients

  per month (30 client days) over 6 consecutive months

Secondary Outcomes (3)

• Compare the length of time in case management for MD.2 clients to control clients.

  Over 6 consecutive months.

• Measure changes in caregiver stressors and burden between those with the MD.2 and those with their usual medication routine.

  Over 6 consecutive months

• Determine if cognitive and functional characteristics influence compliance rates among the frail elderly using the MD.2.

  Over 6 consecutive months

Study Arms (2)

A

EXPERIMENTAL

Those subjects that receive an MD.2 Medication Dispenser

Behavioral: MD.2 Medication Dispenser

B

NO INTERVENTION

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.

Behavioral: MD.2 Medication Dispenser

Interventions

MD.2 Medication Dispenser BEHAVIORAL

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.

A; B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Interactive Medical Developments: lead
• University of Iowa: collaborator
• Department of Health and Human Services: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242-1101, United States

RECRUITING

Related Publications (14)

• Stuck AE, Beers MH, Steiner A, Aronow HU, Rubenstein LZ, Beck JC. Inappropriate medication use in community-residing older persons. Arch Intern Med. 1994 Oct 10;154(19):2195-200.

  PMID: 7944840 BACKGROUND

• Aparasu RR, Mort JR. Inappropriate prescribing for the elderly: beers criteria-based review. Ann Pharmacother. 2000 Mar;34(3):338-46. doi: 10.1345/aph.19006.

  PMID: 10917382 BACKGROUND

• Zhan C, Sangl J, Bierman AS, Miller MR, Friedman B, Wickizer SW, Meyer GS. Potentially inappropriate medication use in the community-dwelling elderly: findings from the 1996 Medical Expenditure Panel Survey. JAMA. 2001 Dec 12;286(22):2823-9. doi: 10.1001/jama.286.22.2823.

  PMID: 11735757 BACKGROUND

• Gray SL, Mahoney JE, Blough DK. Adverse drug events in elderly patients receiving home health services following hospital discharge. Ann Pharmacother. 1999 Nov;33(11):1147-53. doi: 10.1345/aph.19036.

  PMID: 10573310 BACKGROUND

• Kimura H. Effects of caffeine on cleavage delay of sea urchin eggs induced by ethidium bromide or puromycin. J Radiat Res. 1975 Jun;16(2):125-31. doi: 10.1269/jrr.16.125. No abstract available.

  PMID: 1171974 BACKGROUND

• Bero LA, Lipton HL, Bird JA. Characterization of geriatric drug-related hospital readmissions. Med Care. 1991 Oct;29(10):989-1003. doi: 10.1097/00005650-199110000-00005.

  PMID: 1921531 BACKGROUND

• Chrischilles EA, Segar ET, Wallace RB. Self-reported adverse drug reactions and related resource use. A study of community-dwelling persons 65 years of age and older. Ann Intern Med. 1992 Oct 15;117(8):634-40. doi: 10.7326/0003-4819-117-8-634.

  PMID: 1530194 BACKGROUND

• Farris KD, Kelly MW, Tryon J. Clock drawing test and medication complexity index as indicators of medication management capacity: a pilot study. J Am Pharm Assoc (Wash). 2003 Jan-Feb;43(1):78-81. No abstract available.

  PMID: 12585756 BACKGROUND

• Col N, Fanale JE, Kronholm P. The role of medication noncompliance and adverse drug reactions in hospitalizations of the elderly. Arch Intern Med. 1990 Apr;150(4):841-5.

  PMID: 2327844 BACKGROUND

• DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002 Sep;40(9):794-811. doi: 10.1097/00005650-200209000-00009.

  PMID: 12218770 BACKGROUND

• Buckwalter KC, Wakefield BJ, Hanna B, Lehmann J. New technology for medication adherence: electronically managed medication dispensing system. J Gerontol Nurs. 2004 Jul;30(7):5-8. doi: 10.3928/0098-9134-20040701-04. No abstract available.

  PMID: 15287321 BACKGROUND

• Maddigan SL, Farris KB, Keating N, Wiens CA, Johnson JA. Predictors of older adults' capacity for medication management in a self-medication program: a retrospective chart review. J Aging Health. 2003 May;15(2):332-52. doi: 10.1177/0898264303251893.

  PMID: 12795276 BACKGROUND

• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 BACKGROUND

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Behavior

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Karen Farris, Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Farris, Ph.D.

CONTACT

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

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 19, 2007
• Study Start: January 1, 2006
• Study Completion: May 1, 2008
• Last Updated: October 8, 2009

Record last verified: 2007-11

Locations

US (1)