Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
600 participants
INTERVENTIONAL
2006-01-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Home Care Medication Management Program for the Frail Elderly
NCT01321853
Medication Empowerment and Deprescription for Safety (MEDS) Study
NCT04612166
Evaluation of a Habit-based Work-up to Support Medication Adherence
NCT06230978
Deprescribing for Older Adults After Hospital Discharge in Home Health Care
NCT05630144
Multi-Center Medication Reconciliation Quality Improvement Study
NCT01337063
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Those subjects that receive an MD.2 Medication Dispenser
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Iowa
OTHER
Department of Health and Human Services
FED
National Institutes of Health (NIH)
NIH
Interactive Medical Developments
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karen Farris, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa
Iowa City, Iowa, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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. doi: 10.1097/00005650-200209000-00009.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHS 2003-2 FAST TRACK
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.