Clinical trial NCT00560001: MD.2 Medication Dispenser Medication Adherence Study
Official title: Medication Dispenser: MD2: Improving Health Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Frail Elderly
Medication Errors
Keywords: frail elderly
medication errors
patient compliance & attitudes
guideline adherence
Lead sponsor: Interactive Medical Developments
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
name: Department of Health and Human Services
name: National Institutes of Health (NIH)
First posted: 2007-11-19
Enrollment: 600
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 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

Primary outcomes:
measure: The rate of hospitalizations and emergency room visits will be compared between the MD.2 and control clients
timeFrame: per month (30 client days) over 6 consecutive months
Secondary outcomes:
measure: Compare the length of time in case management for MD.2 clients to control clients.
timeFrame: Over 6 consecutive months.
measure: Measure changes in caregiver stressors and burden between those with the MD.2 and those with their usual medication routine.
timeFrame: Over 6 consecutive months
measure: Determine if cognitive and functional characteristics influence compliance rates among the frail elderly using the MD.2.
timeFrame: Over 6 consecutive months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Karen Farris, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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