MD.2 Medication Dispenser Medication Adherence Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Frail Elderly Medication Errors	Behavioral: MD.2 Medication Dispenser	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Medication Dispenser: MD2: Improving Health Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Medication Errors

U.S. FDA Resources

Further study details as provided by Interactive Medical Developments:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Compare the length of time in case management for MD.2 clients to control clients. [ Time Frame: Over 6 consecutive months. ]
Measure changes in caregiver stressors and burden between those with the MD.2 and those with their usual medication routine. [ Time Frame: Over 6 consecutive months ]
Determine if cognitive and functional characteristics influence compliance rates among the frail elderly using the MD.2. [ Time Frame: Over 6 consecutive months ]

Estimated Enrollment:	600
Study Start Date:	January 2006
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
Experimental: A Those subjects that receive an MD.2 Medication Dispenser	Behavioral: 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.
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.	Behavioral: 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.

Arms

Assigned Interventions

Experimental: A

Those subjects that receive an MD.2 Medication Dispenser

Behavioral: 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.

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.

Behavioral: 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.

Detailed Description:

A sizeable portion of admissions to hospital and even nursing homes can be avoided if individuals with medication management problems were provided assistive devices to assist with their medications. The MD.2 medication dispenser and monitoring system was developed by Interactive Medical Developments LC and may offer increased support to the elderly with fewer human resources and a substantially reduced cost to the public health system. A rigorous evaluation of this technology has not been conducted. The objective of this Phase III clinical trial (Phase II of this STTR Fast Track Application) is to quantify the benefits of using the MD.2 on health outcomes. The specific aims are to: (1) Quantify healthcare utilization including hospitalizations and emergency room visits for MD.2 clients compared to control clients, (2) Determine the length of time in case management for MD.2 clients compared to control clients, (3) Measure changes in caregiver burden between those with the MD.2 and those with usual medication routines and (4) Determine if cognitive and functional characteristics influence compliance rates among the MD.2 clients and control clients. This study will be conducted in all counties in four of the Area Agencies on Aging in Iowa (who participated in the Phase I study), with the Veteran's Administration(VA)in Iowa, and with Area Agencies on Aging in Illinois. One hundred and fifty clients will be randomized to receive the MD.2 and 150 clients will be randomized to the control group. Primary caregivers for these 300 subjects will also be recruited. Nurses employed by Interactive Medical Developments LC will collect all data. From homecare charts/claims, age, sex, residence, living status, social support, activities of daily living, instrumental activities of daily living, cognition, medical conditions and medication lists will be obtained. Enrolled subjects will also complete an interviewer-administered survey of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits. Caregivers will complete the Caregiver Burden Interview. Poisson regression and Cox proportional hazards models will be the primary statistical approaches.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560001

Contacts

Contact: Karen Farris, Ph.D.	319-384-4516	karen-farris@uiowa.edu
Contact: Julie Lang, M.S.; M.B.A	319-384-2815	julie-lang@uiowa.edu

Locations

United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242-1101
Contact: Julie Lang, M.S.; M.B.A. 319-384-2815 julie-lang@uiowa.edu
Principal Investigator: Karen Farris, Ph.D.

Sponsors and Collaborators

Interactive Medical Developments

University of Iowa

Department of Health and Human Services

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Karen Farris, Ph.D.

University of Iowa

More Information

Additional Information:

Click here for more information about this study: MD.2 Medication Dispenser Medication Adherence Study This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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

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.

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.

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

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

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.

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.

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.

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.

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. No abstract available.

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.

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.

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

ClinicalTrials.gov Identifier:	NCT00560001 History of Changes
Other Study ID Numbers:	PHS 2003-2 FAST TRACK, 5 R42 AG021844-02
Study First Received:	November 15, 2007
Last Updated:	October 7, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Interactive Medical Developments:

frail elderly
medication errors
patient compliance & attitudes
guideline adherence

ClinicalTrials.gov processed this record on May 22, 2013