HypertensionNCT01744392
Medication Adherence With Polyglot Meducation
A study testing education intervention in people with Hypertension and Diabetes, run by Durham VA Medical Center at 1 site in United States.
Trial summary
The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25 individuals among veterans with cardiovascular disease risk factors including Hypertension (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the hospital-based primary care clinics associated with Durham VAMC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes, Hypercholesterolemia
- What is being tested?
- education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in one of three DVAMC Primary Care Clinics affiliated with the hospital for at least one year;
- At least one visit to a primary care provider (PCP) at Durham VAMC associated primary care clinics in the previous 12 months;
- Outpatient diagnostic code for hypertension (> 140/90), diabetes and/or hypercholesterolemia
- Prescription for metoprolol tartrate (twice a day beta blocker, most common 2 day medication prescribed in the VA)
- Baseline Medication Possession Ratio (MPR) of < 80% indicating medication non adherence
- More than 9 active medications.
Who cannot join
- diagnosed with metastatic cancer,
- diagnosed with dementia documented in medical record,
- active diagnosis of psychosis documented in medical record with admission with last 30 days
- participating in another clinical trial,
- not currently receiving care at the Durham VAMC
- resident of a nursing home,
Show all 11Show fewer
- hard time seeing type/printing on books, magazines articles, etc.
- hard time hearing or speaking on the telephone
- limited/no access to telephone
- currently a patient in the primary care pharmacist medication management clinic at Durham VAMC
- plans to move medical care from DVAMC in next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center
Durham, North Carolina, 27701
About this study
Official title: Evaluate Changes in Medication Adherence and Patient Perspective of Polyglot Systems, Inc's Meducation Technology
The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25 individuals among veterans with cardiovascular disease risk factors including Hypertension (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the hospital-based primary care clinics associated with Durham VAMC. The investigators will examine veteran's perception and ease of using an innovative tool to help improve medication adherence to cardiovascular medications. This study aims to focus on patients with multiple chronic conditions and their caregivers to address 1) appropriate use of medications 2)maximize patient self-care and care by families and other caregivers 3) make available a tool for medication management 4) managing complex regimens, and 5) addressing health literacy.
Read the detailed description
Recruitment letter:
Each week, the research assistant (RA) will identify participants who have a medical appointment scheduled 3 weeks from the current date from the statistician's list of eligible participants. The RA will review Computerized Patient Record System (CPRS) to confirm enrollment at the Durham VA Medical Center (DVAMC) or Raleigh Community Based Outpatient Clinic (CBOC), identify participants' primary care provider and conduct a preliminary medical record review of the exclusion criteria listed above.
An introductory recruitment letter signed by the patient's provider will be sent to these participants.
Telephone Screening:
The RA will call the participants between 1 and 2 weeks later to assess interest and eligibility using the telephone screening script. During this telephone call, the RA will ask permission to conduct the telephone screening to further evaluate the participants' eligibility to participate in the study. These screening questions are being asked because exclusion criteria may not be accurately reflected in the VA medical record. If participants agree to meet with study team to further discuss the project they will be scheduled for an interview. If requested, participant will be sent an appointment reminder letter signed by the study principal investigator and/or project coordinator.
All participants will be sent reminder letters up to 3 weeks prior to their scheduled 3 and 6 month follow-up appointments.
Consent Process:
At this interview, the patient will be given greater detail about the study, and if agreeable, will provide written informed consent. Participants who consent to participate in the study and agree to be digitally audio recorded will also have complete form 10-3203 "Consent for use of picture and /or voice" at baseline.
Interview Procedures:
RAs will obtain the participants' outcome values (i.e., BP) from the clinical record at baseline, at 3 month follow-up. This information will be double-entered into an application on the Health Services Research \& Development (HSRD) VA Server. At baseline and 3-month follow-up contacts, participants will also undergo an interview to determine secondary outcome variables including self-reported medication adherence and perceptions of the intervention. The baseline interview will be conducted in person if possible, however, at the 3 month follow-up appointment the interview will be conducted by telephone. The RA's will work with patients to be seen in a 6 week window around the original follow-up appointment. Pill refill will be calculated for all individuals at 6 months.
Participant Contacts In-person meeting - Baseline After the consent process, at the baseline interview, a research assistant(RA) will conduct the outcome assessment procedures, which includes asking the participant questions about their age,race, medical history, self reported adherence to cardiovascular medications and their understanding about the risk of cardiovascular disease. The RA will also ask questions about their lifestyle, and quality of life. Participants who qualify for enrollment and provide informed consent will meet with the research pharmacist for education use of the Meducation Calendar.
3 month follow-up interview. A research assistant will contact participant via phone to determine secondary outcome variables including self reported medication adherence to cardiovascular medications. The entire interview should take no more than 30 minutes.
Optional Qualitative: 3 month phone interview: For selected intervention participants only the RA will conduct a questionnaire about the participant's perception to determine which aspects of the Meducation Calendar intervention were most helpful for participants and which aspects need revision. Participants who agreed to the qualitative interview during the consent process will be asked during the 3 month interview to confirm their continued desire to participate in the audio recorded phone interview if selected. This visit should take no more than 30 minutes. Those selected to participate will be scheduled to complete the qualitative interview over the phone within 15 days from the time they complete the intervention and interview. The qualitative interview will be audio recorded digitally on a VA owned and configured computer and later transcribed using VA owned computer software. Names will not be associated with the audio recordings. After all recordings have been analyzed and coded, recordings will be destroyed in accordance with VA Information Security procedures. This phone call for the optional qualitative interview should take no more than 30 minutes.
- Conditions
- Hypertension, Diabetes, Hypercholesterolemia
- Being tested
- education intervention
- Medical subject headings
- Hypertension, Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education interventionBehavioural
Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
| Study group | Role | What they receive |
|---|---|---|
| education intervention | Experimental | The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Receives: Behavioral: education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Possession Ratio at Baseline
Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time." The time period for the assessment for baseline MPR 12 months prior to enrollment.
Measured: baseline
Medication Possession Ratio at 6 Months
Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time." The time period for the assessment for 6 months MPR 6 months after enrollment.
Measured: 6 months
Secondary outcomes (8)
Blood Pressure at Baseline
Clinical Characteristics at Baseline for Systolic \& Diastolic Blood Pressure,
Measured: baseline
Blood Pressure at 6 Months
Clinical Characteristics at 6 months for Systolic \& Diastolic Blood Pressure,
Measured: 6 months
Cholesterol & Creatinine Levels at Baseline
Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine
Measured: baseline
Cholesterol & Creatinine Levels at 6 Months
Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine
Measured: 6 months
Weight at Baseline
Clinical Characteristics at Baseline for Weight
Measured: baseline
Weight at 6 Months
Clinical Characteristics at 6 months for Weight
Measured: 6 months
Pulse at Baseline
Clinical Characteristics at Baseline for Pulse
Measured: baseline
Pulse at 6 Months
Clinical Characteristics at 6 month for Pulse
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durham VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hayden B Bosworth, PhD, Principal investigator, Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744392
- Sponsor's protocol ID
- 01658
- Status last verified
- Oct 2015
- First submitted
- 5 Dec 2012
- Last updated
- 24 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Changes in Medication Adherence and Patient Perspective of Polyglot Systems, Inc's Meducation Technology
- ClinicalTrials.gov ID
- NCT01744392
- Acronym / sponsor ID
- 01658
- Conditions
- Hypertension, Diabetes, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Durham VA Medical CenterUS federal agency
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Posted 24 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25 individuals among veterans with cardiovascular disease risk factors including Hypertension (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the hospital-based primary care clinics associated with Durham VAMC. The investigators will examine veteran's perception and ease of using an innovative tool to help improve medication adherence to cardiovascular medications. This study aims to focus on patients with multiple chronic conditions and their caregivers to address 1) appropriate use of medications 2)maximize patient self-care and care by families and other caregivers 3) make available a tool for medication management 4) managing complex regimens, and 5) addressing health literacy.
Detailed description
Recruitment letter:
Each week, the research assistant (RA) will identify participants who have a medical appointment scheduled 3 weeks from the current date from the statistician's list of eligible participants. The RA will review Computerized Patient Record System (CPRS) to confirm enrollment at the Durham VA Medical Center (DVAMC) or Raleigh Community Based Outpatient Clinic (CBOC), identify participants' primary care provider and conduct a preliminary medical record review of the exclusion criteria listed above.
An introductory recruitment letter signed by the patient's provider will be sent to these participants.
Telephone Screening:
The RA will call the participants between 1 and 2 weeks later to assess interest and eligibility using the telephone screening script. During this telephone call, the RA will ask permission to conduct the telephone screening to further evaluate the participants' eligibility to participate in the study. These screening questions are being asked because exclusion criteria may not be accurately reflected in the VA medical record. If participants agree to meet with study team to further discuss the project they will be scheduled for an interview. If requested, participant will be sent an appointment reminder letter signed by the study principal investigator and/or project coordinator.
All participants will be sent reminder letters up to 3 weeks prior to their scheduled 3 and 6 month follow-up appointments.
Consent Process:
At this interview, the patient will be given greater detail about the study, and if agreeable, will provide written informed consent. Participants who consent to participate in the study and agree to be digitally audio recorded will also have complete form 10-3203 "Consent for use of picture and /or voice" at baseline.
Interview Procedures:
RAs will obtain the participants' outcome values (i.e., BP) from the clinical record at baseline, at 3 month follow-up. This information will be double-entered into an application on the Health Services Research \& Development (HSRD) VA Server. At baseline and 3-month follow-up contacts, participants will also undergo an interview to determine secondary outcome variables including self-reported medication adherence and perceptions of the intervention. The baseline interview will be conducted in person if possible, however, at the 3 month follow-up appointment the interview will be conducted by telephone. The RA's will work with patients to be seen in a 6 week window around the original follow-up appointment. Pill refill will be calculated for all individuals at 6 months.
Participant Contacts In-person meeting - Baseline After the consent process, at the baseline interview, a research assistant(RA) will conduct the outcome assessment procedures, which includes asking the participant questions about their age,race, medical history, self reported adherence to cardiovascular medications and their understanding about the risk of cardiovascular disease. The RA will also ask questions about their lifestyle, and quality of life. Participants who qualify for enrollment and provide informed consent will meet with the research pharmacist for education use of the Meducation Calendar.
3 month follow-up interview. A research assistant will contact participant via phone to determine secondary outcome variables including self reported medication adherence to cardiovascular medications. The entire interview should take no more than 30 minutes.
Optional Qualitative: 3 month phone interview: For selected intervention participants only the RA will conduct a questionnaire about the participant's perception to determine which aspects of the Meducation Calendar intervention were most helpful for participants and which aspects need revision. Participants who agreed to the qualitative interview during the consent process will be asked during the 3 month interview to confirm their continued desire to participate in the audio recorded phone interview if selected. This visit should take no more than 30 minutes. Those selected to participate will be scheduled to complete the qualitative interview over the phone within 15 days from the time they complete the intervention and interview. The qualitative interview will be audio recorded digitally on a VA owned and configured computer and later transcribed using VA owned computer software. Names will not be associated with the audio recordings. After all recordings have been analyzed and coded, recordings will be destroyed in accordance with VA Information Security procedures. This phone call for the optional qualitative interview should take no more than 30 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| education intervention | Experimental | Behavioral: education interventionThe intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Enrolled in one of three DVAMC Primary Care Clinics affiliated with the hospital for at least one year;
- At least one visit to a primary care provider (PCP) at Durham VAMC associated primary care clinics in the previous 12 months;
- Outpatient diagnostic code for hypertension (> 140/90), diabetes and/or hypercholesterolemia
- Prescription for metoprolol tartrate (twice a day beta blocker, most common 2 day medication prescribed in the VA)
- Baseline Medication Possession Ratio (MPR) of < 80% indicating medication non adherence
Key exclusion criteria (11 listed)
- diagnosed with metastatic cancer,
- diagnosed with dementia documented in medical record,
- active diagnosis of psychosis documented in medical record with admission with last 30 days
- participating in another clinical trial,
- not currently receiving care at the Durham VAMC
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 |
|---|---|---|
| education interventionEach patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development. | Behavioural | education intervention |
Primary outcome
Medication Possession Ratio at Baseline
Time frame: baseline
Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time." The time period for the assessment for baseline MPR 12 months prior to enrollment.
Medication Possession Ratio at 6 Months
Time frame: 6 months
Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time." The time period for the assessment for 6 months MPR 6 months after enrollment.
8 secondary outcomes
Blood Pressure at Baseline
Time frame: baseline
Blood Pressure at 6 Months
Time frame: 6 months
Cholesterol & Creatinine Levels at Baseline
Time frame: baseline
Cholesterol & Creatinine Levels at 6 Months
Time frame: 6 months
Weight at Baseline
Time frame: baseline
Weight at 6 Months
Time frame: 6 months
Pulse at Baseline
Time frame: baseline
Pulse at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hayden B Bosworth, PhD principal investigator
Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education intervention in people with Hypertension and Diabetes, run by Durham VA Medical Center 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 11 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 24 Nov 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medication Possession Ratio at Baseline (time frame: baseline). The study lists 2 primary outcomes in all. 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 24 Nov 2015.