MD.2 Medication Dispenser Medication Adherence Study

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

Detailed Description
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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.

Official Title
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Medication Dispenser: MD2: Improving Health Outcomes

Conditions
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Frail Elderly, Medication Errors

Intervention / Treatment
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* Behavioral: MD.2 Medication Dispenser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Those subjects that receive an MD.2 Medication Dispenser | Behavioral: MD.2 Medication Dispenser<br>* 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.<br>|
| No Intervention: B<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frail elderly, medication errors, patient compliance & attitudes, guideline adherence