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Frail ElderlyPhase 3NCT00560001

MD.2 Medication Dispenser Medication Adherence Study

A Phase 3 study testing MD.2 Medication Dispenser in people with Frail Elderly and Medication Errors, run by Interactive Medical Developments at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 60 years and older
Conditions the study is for
Frail Elderly, Medication Errors
What is being tested?
MD.2 Medication Dispenser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
Jan 2006to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

United States1 site, 1 recruiting

  • University of Iowa

    Iowa City, Iowa, 52242-1101

    Julie Lang, M.S.; M.B.A., 319-384-2815, julie-lang@uiowa.edu

    Karen Farris, Ph.D.

    Recruiting

Other trials in United States

About this study

Official title: Medication Dispenser: MD2: Improving Health Outcomes

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

Read the 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.

Being tested
MD.2 Medication Dispenser
Keywords
frail elderly, medication errors, patient compliance & attitudes, guideline adherence
Medical subject headings
Patient Compliance, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MD.2 Medication DispenserBehavioural

    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.

Study groups in NCT00560001
Study groupRoleWhat they receive
AExperimentalThose subjects that receive an MD.2 Medication Dispenser
Receives: Behavioral: MD.2 Medication Dispenser
BNo interventionControl subjects that do not receive an MD.2 Medication Dispenser, but continue to take their medications utilizing standard care, such as pill boxes, etc.
Receives: Behavioral: MD.2 Medication Dispenser

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: per month (30 client days) over 6 consecutive months

Secondary outcomes (3)

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

    Measured: Over 6 consecutive months.

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

    Measured: Over 6 consecutive months

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

    Measured: Over 6 consecutive months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2007 (estimated)
  2. Study startJan 2006
  3. Study completionMay 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00560001
Sponsor's protocol ID
PHS 2003-2 FAST TRACK
Other IDs
5R42AG021844-02
Status last verified
Nov 2007
First submitted
15 Nov 2007
Last updated
8 Oct 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 7944840

  • 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.

    PubMed 10917382

  • 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.

    PubMed 11735757

  • 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.

    PubMed 10573310

  • 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.

    PubMed 1171974

  • 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.

    PubMed 1921531

  • 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.

    PubMed 1530194

  • 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.

    PubMed 12585756

  • 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.

    PubMed 2327844

  • 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.

    PubMed 12218770

  • 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.

    PubMed 15287321

  • 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.

    PubMed 12795276

  • 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.

    PubMed 3945130

  • 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.

    PubMed 7203086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MD.2 Medication Dispenser in people with Frail Elderly and Medication Errors, run by Interactive Medical Developments at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karen Farris, Ph.D. (319-384-4516, karen-farris@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00560001, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2009.

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