Chronic IllnessPhase 1NCT01321853
Home Care Medication Management Program for the Frail Elderly
A Phase 1 study testing MD2 machine and nurse care coordination and Medplanner and Nurse Care Coordination in people with Chronic Illness and Cognitive Impairment, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year period. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Illness, Cognitive Impairment
- What is being tested?
- MD2 machine and nurse care coordination and Medplanner and Nurse Care Coordination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2010
- Phase
- Phase 1
- 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
- Age 60 and older
- Medicare Primary Payer
- Impaired Medication Management ability as indicated by a score of 1 or higher on OASIS discharge assessment item M0780
- Impaired Cognitive Functioning but able to follow directions with prompting as indicated by a score of 1 or 2 on OASIS discharge assessment item M0560
- working telephone line
- Discharge from home health care
Who cannot join
- Not English speaking
- Terminal diagnosis or hospice care
- Use of other device for medications
- Medicare via managed care
- Use of private home care agency for medication management
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53201
About this study
The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year period. The investigators propose a longitudinal three group repeated measures design, enrolling, and randomly assigning, clients who are discharged from a home health care agency with documented problems in medication management. One group will receive the MD.2 medication dispensing device and nurse coordination, the second group will receive a Medplanner: a simple box that has separate compartments for individual medication times over the course of a week plus nurse coordination, and the final group will receive Usual Care.
The study hypotheses are the following:
Read more
H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Medplanner Group.
H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Usual Care Group.
H3: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H4: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the Medplanner Group as compared to the Usual Care Group.
H5: The nursing home admission rate will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H6: The nursing home admission rate will be significantly lower for the Medplanner Group as compared to the Usual Care Group.
H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H8: The total cost of care will be significantly lower for the Medplanner Group as compared to The Usual Care Group.
H9: There will be incremental savings in terms of costs per quality adjusted life year (QALY) gained in the MD.2 group compared with the Medplanner Group.
H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner group compared with the Usual Care Group.
- Conditions
- Chronic Illness, Cognitive Impairment
- Being tested
- MD2 machine and nurse care coordination, Medplanner and Nurse Care Coordination
- Keywords
- Home health care, Medication Management, Cognitive impairment, Medication adherence, Older adults, Care Coordination management
- Medical subject headings
- Chronic Disease, Cognitive Dysfunction, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD2 machine and nurse care coordinationOther
MD2 machine filled at least every 2 weeks and subjects monitored for changes in condition. Additional visits made as needed. Care is coordinated with other providers such as the primary care physician and pharmacist.
Medplanner and Nurse Care CoordinationOther
Medications are dispensed via a medplanner filled by a nurse at least every 2 weeks and subjects monitored for changes in condition. Additional visits made as needed. Care is coordinated with other providers such as the primary care physician and pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Machine and NCC | Experimental | Medications dispensed to subject via MD2 machine and nurse care coordination used to coordinate care among providers and fill machine at least every 2 weeks. Receives: Other: MD2 machine and nurse care coordination |
| Medplanner and NCC | Experimental | Medications loaded in medplanner by nurse care coordinator who coordinates care among providers and visits subject at least every 2 weeks Receives: Other: Medplanner and Nurse Care Coordination |
| Usual Care Group | No intervention | Admitted post home health care with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale
The Geriatric Depression Scale (GDS) was developed to identify depression in older adults. The original GDS was 30 questions, however, fifteen- and five-question versions also exist. When tested on the oldest old in the community, the 15-item scale was demonstrated to have favorable reliability and validity results. Impaired cognitive function (MMSE < 28) reduced the tool's specificity, but sensitivity was not affected by lower MMSE scores. The tool is scored into depression categories of "none/mild", "moderate" and "major".
Measured: 12 months
Physical Performance Test (PPT)
This functional status test has demonstrated reliability and validity, is easy to administer, can be performed in a reasonable period of time, and imposes little burden on the individual being tested. Even men and women with mild to moderate dementia are capable of understanding the test and performing activities reliably. There are 7 items on the test that range in difficulty from very easy to perform (writing a sentence) to challenging (picking up a penny), thus encompassing a spectrum of physical capabilities.
Measured: 12 months
SF-36 Health Survey
This tool is a widely used generic health status questionnaire measuring eight dimensions of health status: physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. In addition, the SF-36 can be transformed into a Health State Utility Index that allows for health improvements to be stated in terms of quality adjusted life years (QALYs) gained.
Measured: 12 months
Mental Mental Status Exam (MMSE)
This 11-item measure screens for cognitive abilities in the domains of orientation, memory, attention, recall, language and visual/spatial orientation. The MMSE may be a categorical or continuous-level variable. When used as a categorical variable, the MMSE is broken down into 4 levels: (a) score range 24-30 is considered within normal limits (WNL), (b) score range of 18-23 is considered mild cognitive impairment, (c) score range of 12-17 is considered moderate cognitive impairment, and (d) a score range of 11 or less is considered to be severe cognitive impairment.
Measured: 12 months
Hospitalization
Medicare claims data will be the source of information for this measure.
Measured: 12 month enrollment period
Hospital Days
Medicare claims data will be the source of information for this measure.
Measured: 12 Month Enrollment Period
Emergency Department Visits
Medicare claims data will be the source of information for this measure.
Measured: 12 month Enrollment Period
Medicare Costs
Medicare claims data will be the source of information for this measure.
Measured: 12 Month Enrollment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMay 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Karen S Marek, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321853
- Sponsor's protocol ID
- 144PG09
- Other IDs
- 5R01NR008911
- Status last verified
- Jan 2012
- First submitted
- 15 Mar 2011
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marek KD, Stetzer F, Ryan PA, Bub LD, Adams SJ, Schlidt A, Lancaster R, O'Brien AM. Nurse care coordination and technology effects on health status of frail older adults via enhanced self-management of medication: randomized clinical trial to test efficacy. Nurs Res. 2013 Jul-Aug;62(4):269-78. doi: 10.1097/NNR.0b013e318298aa55.
PubMed 23817284
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Care Medication Management Program for the Frail Elderly
- ClinicalTrials.gov ID
- NCT01321853
- Acronym / sponsor ID
- 144PG09
- Conditions
- Chronic Illness, Cognitive Impairment
- Keywords
- Home health care, Medication Management, Cognitive impairment, Medication adherence, Older adults, Care Coordination management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee, National Institute of Nursing Research (NINR)
- Study start
- May 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year period. The investigators propose a longitudinal three group repeated measures design, enrolling, and randomly assigning, clients who are discharged from a home health care agency with documented problems in medication management. One group will receive the MD.2 medication dispensing device and nurse coordination, the second group will receive a Medplanner: a simple box that has separate compartments for individual medication times over the course of a week plus nurse coordination, and the final group will receive Usual Care.
The study hypotheses are the following:
H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Medplanner Group.
H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Usual Care Group.
H3: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H4: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the Medplanner Group as compared to the Usual Care Group.
H5: The nursing home admission rate will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H6: The nursing home admission rate will be significantly lower for the Medplanner Group as compared to the Usual Care Group.
H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H8: The total cost of care will be significantly lower for the Medplanner Group as compared to The Usual Care Group.
H9: There will be incremental savings in terms of costs per quality adjusted life year (QALY) gained in the MD.2 group compared with the Medplanner Group.
H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner group compared with the Usual Care Group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Machine and NCC | Experimental | Other: MD2 machine and nurse care coordinationMedications dispensed to subject via MD2 machine and nurse care coordination used to coordinate care among providers and fill machine at least every 2 weeks. |
| Medplanner and NCC | Experimental | Other: Medplanner and Nurse Care CoordinationMedications loaded in medplanner by nurse care coordinator who coordinates care among providers and visits subject at least every 2 weeks |
| Usual Care Group | No intervention | –Admitted post home health care with no intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 and older
- Medicare Primary Payer
- Impaired Medication Management ability as indicated by a score of 1 or higher on OASIS discharge assessment item M0780
- Impaired Cognitive Functioning but able to follow directions with prompting as indicated by a score of 1 or 2 on OASIS discharge assessment item M0560
- working telephone line
Key exclusion criteria (5 listed)
- Not English speaking
- Terminal diagnosis or hospice care
- Use of other device for medications
- Medicare via managed care
- Use of private home care agency for medication management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD2 machine and nurse care coordinationMD2 machine filled at least every 2 weeks and subjects monitored for changes in condition. Additional visits made as needed. Care is coordinated with other providers such as the primary care physician and pharmacist. | Other | Machine and NCC |
| Medplanner and Nurse Care CoordinationMedications are dispensed via a medplanner filled by a nurse at least every 2 weeks and subjects monitored for changes in condition. Additional visits made as needed. Care is coordinated with other providers such as the primary care physician and pharmacist. | Other | Medplanner and NCC |
Primary outcome
Geriatric Depression Scale
Time frame: 12 months
The Geriatric Depression Scale (GDS) was developed to identify depression in older adults. The original GDS was 30 questions, however, fifteen- and five-question versions also exist. When tested on the oldest old in the community, the 15-item scale was demonstrated to have favorable reliability and validity results. Impaired cognitive function (MMSE < 28) reduced the tool's specificity, but sensitivity was not affected by lower MMSE scores. The tool is scored into depression categories of "none/mild", "moderate" and "major".
Physical Performance Test (PPT)
Time frame: 12 months
This functional status test has demonstrated reliability and validity, is easy to administer, can be performed in a reasonable period of time, and imposes little burden on the individual being tested. Even men and women with mild to moderate dementia are capable of understanding the test and performing activities reliably. There are 7 items on the test that range in difficulty from very easy to perform (writing a sentence) to challenging (picking up a penny), thus encompassing a spectrum of physical capabilities.
SF-36 Health Survey
Time frame: 12 months
This tool is a widely used generic health status questionnaire measuring eight dimensions of health status: physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. In addition, the SF-36 can be transformed into a Health State Utility Index that allows for health improvements to be stated in terms of quality adjusted life years (QALYs) gained.
Mental Mental Status Exam (MMSE)
Time frame: 12 months
This 11-item measure screens for cognitive abilities in the domains of orientation, memory, attention, recall, language and visual/spatial orientation. The MMSE may be a categorical or continuous-level variable. When used as a categorical variable, the MMSE is broken down into 4 levels: (a) score range 24-30 is considered within normal limits (WNL), (b) score range of 18-23 is considered mild cognitive impairment, (c) score range of 12-17 is considered moderate cognitive impairment, and (d) a score range of 11 or less is considered to be severe cognitive impairment.
Hospitalization
Time frame: 12 month enrollment period
Medicare claims data will be the source of information for this measure.
Hospital Days
Time frame: 12 Month Enrollment Period
Medicare claims data will be the source of information for this measure.
Emergency Department Visits
Time frame: 12 month Enrollment Period
Medicare claims data will be the source of information for this measure.
Medicare Costs
Time frame: 12 Month Enrollment Period
Medicare claims data will be the source of information for this measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- Derived from this study: PubMed 23817284Marek KD, Stetzer F, Ryan PA, Bub LD, Adams SJ, Schlidt A, Lancaster R, O'Brien AM. Nurse care coordination and technology effects on health status of frail older adults via enhanced self-management of medication: randomized clinical trial to test efficacy. Nurs Res. 2013 Jul-Aug;62(4):269-78. doi: 10.1097/NNR.0b013e318298aa55.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen S Marek, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MD2 machine and nurse care coordination and Medplanner and Nurse Care Coordination in people with Chronic Illness and Cognitive Impairment, run by Arizona State University 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jan 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Depression Scale (time frame: 12 months). The study lists 8 primary outcomes in all. 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 NCT01321853, which also lists 1 linked publication.
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 6 Jan 2012.