Compliance of MedicationsCOMADENCT01017432
Compliance Of Medication After Discharge From the Hospital in the Elderly
An observational study of Compliance of Medications and Factors That May Affect Compliance, run by Corewell Health East at 2 sites in United States.
Trial summary
Many elderly patients have multiple medications and variable dosing regimens and the ability for hospitals to properly reconcile medications between what is given on paper to the patient and what the patients take at home depends on the patient's ability to get the medications. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compliance of Medications, Factors That May Affect Compliance
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Jan 2011
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All patients over the age of 65 who are discharged home from the hospital who meet the eligibilty criteria.
Who may be able to join
- Elderly patients (age 65 or older)
- Able to make own decisions (Patient has autonomy) and therefore able to make informed decisions
- Patients with medications upon discharge from the hospital
Who cannot join
- Patients that have the inability to give informed consent secondary to: cognitive disabilities, inability to speak or write or refusal to participate in study.
- Patients that are younger than the age of 65.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospital
Troy, Michigan, 48314
About this study
Many elderly patients have multiple medications and variable dosing regimens and the ability for hospitals to properly reconcile medications between what is given on paper to the patient and what the patients take at home depends on the patient's ability to get the medications. Some patients may delay in getting their medications from the pharmacy after being discharged. For some it may be a lack of transportation, others may feel too ill to travel and may not have family members who will be able to pick up the medications.
It is for these reasons the authors of this study want to inventory the medications that an elderly patient is being discharged on during a home visit and check on the actual prescriptions that a patient has at their house the following 1-2 days after discharge.
Read the detailed description
The goal is to evaluate the effectiveness of discharge instruction in the elderly by assessing medication compliance post-discharge. Patients are identified on the units and from a Beaumont Troy discharge planning master list. Prior to discharge the patients are consented and informed they will be contacted to schedule a home visit. During the home visit, the medications the patient is currently taking are recorded. Discharge medications are recorded from the medical record following the home visit. The Investigator performing the visit is blinded to the discharge medications as the intent of the visit is only to collect data and not to ensure compliance or make clinical judgment regarding the appropriateness of the medication regimen. Anyone 65 or older can be included, who are discharged with medications and can consent. Those excluded are patients who do not live in close proximity and those discharged to extended or long-term care facilities.
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe compliance of medications from a discharge medication list to the meds at home after discharge from the hospital.
Measured: 18 months
Secondary outcomes (1)
To observe if there are secondary factors that affect compliance (i.e. age of the patients, number of medications or herbal medications)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance of MedicationsStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Jobin M Varughese, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017432
- Sponsor's protocol ID
- HIC 2008-252
- Acronym
- COMADE
- Status last verified
- Apr 2011
- First submitted
- 18 Nov 2009
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance Of Medication After Discharge From the Hospital in the Elderly
- ClinicalTrials.gov ID
- NCT01017432
- Acronym / sponsor ID
- COMADE / HIC 2008-252
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Nov 2009 (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.
Many elderly patients have multiple medications and variable dosing regimens and the ability for hospitals to properly reconcile medications between what is given on paper to the patient and what the patients take at home depends on the patient's ability to get the medications. Some patients may delay in getting their medications from the pharmacy after being discharged. For some it may be a lack of transportation, others may feel too ill to travel and may not have family members who will be able to pick up the medications.
It is for these reasons the authors of this study want to inventory the medications that an elderly patient is being discharged on during a home visit and check on the actual prescriptions that a patient has at their house the following 1-2 days after discharge.
Detailed description
The goal is to evaluate the effectiveness of discharge instruction in the elderly by assessing medication compliance post-discharge. Patients are identified on the units and from a Beaumont Troy discharge planning master list. Prior to discharge the patients are consented and informed they will be contacted to schedule a home visit. During the home visit, the medications the patient is currently taking are recorded. Discharge medications are recorded from the medical record following the home visit. The Investigator performing the visit is blinded to the discharge medications as the intent of the visit is only to collect data and not to ensure compliance or make clinical judgment regarding the appropriateness of the medication regimen. Anyone 65 or older can be included, who are discharged with medications and can consent. Those excluded are patients who do not live in close proximity and those discharged to extended or long-term care facilities.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All patients over the age of 65 who are discharged home from the hospital who meet the eligibilty criteria.
Key inclusion criteria (3 listed)
- Elderly patients (age 65 or older)
- Able to make own decisions (Patient has autonomy) and therefore able to make informed decisions
- Patients with medications upon discharge from the hospital
Key exclusion criteria (2 listed)
- Patients that have the inability to give informed consent secondary to: cognitive disabilities, inability to speak or write or refusal to participate in study.
- Patients that are younger than the age of 65.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To observe compliance of medications from a discharge medication list to the meds at home after discharge from the hospital.
Time frame: 18 months
1 secondary outcome
To observe if there are secondary factors that affect compliance (i.e. age of the patients, number of medications or herbal medications)
Time frame: 18 months
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 5 Apr 2011.
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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.
Jobin M Varughese, MD principal investigator
Corewell Health East
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compliance of Medications and Factors That May Affect Compliance, run by Corewell Health East at 2 sites 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 3 inclusion and 2 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 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
To observe compliance of medications from a discharge medication list to the meds at home after discharge from the hospital. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.