DiabetesMeDSNCT01998269
A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS)
An observational study of Diabetes and Hypertension, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The study objective is to develop and test a Measure of Drug Self-Management for use in clinical settings among patients with hypertension and diabetes. While medication non-adherence is a highly recognized public health and patient safety concern, it is rarely assessed in a routine and consistent manner in clinical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult, primary care patients with diabetes and hypertension
Who may be able to join
- be ≥ 18 years old,
- have a diagnosis of diabetes and hypertension,
- be prescribed 3 or more drugs to treat these conditions,
- speak English or Spanish as their primary language,
- have primary responsibility for administering their own medications,
- be a registered UNC patient.
Who cannot join
- severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ambulatory Care Center
Chapel Hill, North Carolina, 27599
About this study
Official title: A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS), an Assessment for Use in Clinical Settings Among English and Spanish-speaking Patients With Hypertension and Diabetes.
The study objective is to develop and test a Measure of Drug Self-Management for use in clinical settings among patients with hypertension and diabetes.
While medication non-adherence is a highly recognized public health and patient safety concern, it is rarely assessed in a routine and consistent manner in clinical settings. With the aging of the US population and rising rates of chronic disease, an increasing number of adults are being prescribed multi-drug regimens that require greater self-management skills. Despite the complexity of medication use, adherence has most commonly been measured as a limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has, over time, simplified how we think of prescription (Rx) medication use and directed attention away from the full range of tasks associated with effective Rx self-management. The field of health literacy research has deconstructed these tasks in considerable detail in recent years, and can offer insight into a more comprehensive measurement of patients' outpatient Rx use.
Read more
There is a clear need for a brief, yet inclusive, measure of adherence that can be used in clinical settings to routinely assess patients' use of complex Rx regimens. Such an assessment could be used to guide clinicians in addressing specific patient challenges to safe and appropriate medication use. In response to this need, our study proposes to develop a new assessment of medication self-management. This unique measure will utilize health literacy best practices to promote patient comprehension and ease-of-use; it will also be tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the tool will be available in both English and Spanish to support use among diverse patient populations. Our study aims are to:
- Develop and refine a Measure of Drug Self-Management (MeDS) prototype.
- Inform the content, structure and delivery of the MeDS through targeted discussions with patients, providers and information technology specialists.
- Test the reliability and validity of the MeDS among patients with diabetes and hypertension
H1: The MeDS will strongly correlate with other self-report adherence measures.
- Conditions
- Diabetes, Hypertension
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with diabetes and hypertension | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Medication Self-Management (MeDS)
The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.
Measured: cross-sectional, 1 hour interview after clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 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 DiabetesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Stacy C Bailey, PhD MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998269
- Sponsor's protocol ID
- 13-3049
- Acronym
- MeDS
- Status last verified
- Nov 2014
- First submitted
- 15 Nov 2013
- Last updated
- 2 Apr 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 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS), an Assessment for Use in Clinical Settings Among English and Spanish-speaking Patients With Hypertension and Diabetes.
- ClinicalTrials.gov ID
- NCT01998269
- Acronym / sponsor ID
- MeDS / 13-3049
- Conditions
- Diabetes, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Northwestern University
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 2 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to develop and test a Measure of Drug Self-Management for use in clinical settings among patients with hypertension and diabetes.
While medication non-adherence is a highly recognized public health and patient safety concern, it is rarely assessed in a routine and consistent manner in clinical settings. With the aging of the US population and rising rates of chronic disease, an increasing number of adults are being prescribed multi-drug regimens that require greater self-management skills. Despite the complexity of medication use, adherence has most commonly been measured as a limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has, over time, simplified how we think of prescription (Rx) medication use and directed attention away from the full range of tasks associated with effective Rx self-management. The field of health literacy research has deconstructed these tasks in considerable detail in recent years, and can offer insight into a more comprehensive measurement of patients' outpatient Rx use.
There is a clear need for a brief, yet inclusive, measure of adherence that can be used in clinical settings to routinely assess patients' use of complex Rx regimens. Such an assessment could be used to guide clinicians in addressing specific patient challenges to safe and appropriate medication use. In response to this need, our study proposes to develop a new assessment of medication self-management. This unique measure will utilize health literacy best practices to promote patient comprehension and ease-of-use; it will also be tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the tool will be available in both English and Spanish to support use among diverse patient populations. Our study aims are to:
- Develop and refine a Measure of Drug Self-Management (MeDS) prototype.
- Inform the content, structure and delivery of the MeDS through targeted discussions with patients, providers and information technology specialists.
- Test the reliability and validity of the MeDS among patients with diabetes and hypertension
H1: The MeDS will strongly correlate with other self-report adherence measures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with diabetes and hypertension | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, primary care patients with diabetes and hypertension
Key inclusion criteria (6 listed)
- be ≥ 18 years old,
- have a diagnosis of diabetes and hypertension,
- be prescribed 3 or more drugs to treat these conditions,
- speak English or Spanish as their primary language,
- have primary responsibility for administering their own medications,
Key exclusion criteria (1 listed)
- severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation.
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
Measure of Medication Self-Management (MeDS)
Time frame: cross-sectional, 1 hour interview after clinic visit
The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 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.
Stacy C Bailey, PhD MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Hypertension, run by University of North Carolina, Chapel Hill 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 1 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 2 Apr 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 2 Apr 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?
Measure of Medication Self-Management (MeDS) (time frame: cross-sectional, 1 hour interview after clinic visit). 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 2 Apr 2015.