GlaucomaNCT03194828
Real-time Glaucoma Medication Adherence
A study testing Medication reminder and Medication monitoring only in people with Glaucoma, run by University of Tennessee at 8 sites in United States.
Trial summary
This study will evaluate the effectiveness of real-time data collected on patients taking topical medication to treat glaucoma. Patients will be randomized to two groups, the first of which will only use the study device to take their medication, while the second will use the study device and receive on-demand… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Medication reminder and Medication monitoring only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 8 sitesUnited States
- Study dates
- 8 May 2017to 15 Jul 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Glaucoma diagnosis
- Prescription for a prostaglandin indicated for glaucoma
- Nonadherent (MPR<80%) in the last 3 months according to pharmacy records
- Owns and operates a mobile phone and willing to receive periodic reminder messages
Who cannot join
- Existing chronic eye condition in addition to glaucoma
- Scheduled for eye surgery in the next 90 days
- Prescription for a medication that will not fit in the device
- Non-English speaking
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Barney's Pharmacy
Augusta, Georgia, 30906
Barney's Pharmacy
Augusta, Georgia, 30907
Hutton Pharmacy
Blackwell, Oklahoma, 74631
Creative Care Pharmacy
Edmond, Oklahoma, 73013
Barney's Pharmacy
Grovetown, Georgia, 30813
Barney's Pharmacy
Louisville, Georgia, 30434
Mustang Drug
Mustang, Oklahoma, 73064
University of Tennessee College of Pharmacy
Nashville, Tennessee, 37210
About this study
Official title: Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma
This study will evaluate the effectiveness of real-time data collected on patients taking topical medication to treat glaucoma. Patients will be randomized to two groups, the first of which will only use the study device to take their medication, while the second will use the study device and receive on-demand reminder messages, when necessary.
Read the detailed description
Adherence to topical medications to treat glaucoma remains sub optimal; however, our understanding of this behavior remains limited due to biased measures of medication use. The Kali Drop device is a potential improvement in our ability to capture medication use in patients using dropper bottles by precisely capturing the amount dispensed in real-time. Moreover, such technology creates data that can be leveraged into driving behavior change using connected mobile technology in order to improve adherence and, ultimately, health outcomes. While evidence suggests that reminders may improve adherence to glaucoma medications, the power of doing so using real-time data has yet to be explored. This study will compare simple monitoring of patients to those who are being monitored and who receive reminder messages when the system determines one is necessary due to a missed dose.
- Conditions
- Glaucoma
- Being tested
- Medication reminder, Medication monitoring only
- Keywords
- Adherence, Mobile health, Real-time data
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reminderBehavioural
Using the real-time data capture of the electronic device, an automated voice call or text message will be sent to active arm participants only when a missed dose is determined
Medication monitoring onlyBehavioural
Patients will use an electronic medication monitoring device to record their actual medication use
| Study group | Role | What they receive |
|---|---|---|
| Monitoring only | Active comparator | Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months Receives: Behavioral: Medication monitoring only |
| Monitoring and reminder | Experimental | Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months and will receive an automated reminder (text or voice) when a missed dose is determined by the device's system Receives: Behavioral: Medication reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Changes and differences in adherence to glaucoma medication between groups
Measured: From study baseline through the 3 months of the intervention
Adherence follow-up
Changes and differences in adherence to glaucoma medication between groups after the intervention
Measured: From study endpoint through the subsequent 3 months
Secondary outcomes (1)
Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale
Differences in self-reported medication-related self-efficacy between groups
Measured: Change from baseline over the 3-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start8 May 2017
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Why it stopped: Lack of sufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Kali Care, Barney's Pharmacy, Creative Care Pharmacy, Hutton Pharmacy, Mustang Drug
- Responsible party
- Sponsor
- Investigators
- Justin Gatwood, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194828
- Sponsor's protocol ID
- 17-05074-XP
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Real-Time Medication Use Monitoring to Improve Adherence in Adults With Glaucoma
- ClinicalTrials.gov ID
- NCT03194828
- Acronym / sponsor ID
- 17-05074-XP
- Conditions
- Glaucoma
- Keywords
- Adherence, Mobile health, Real-time data
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of sufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Kali Care, Barney's Pharmacy, Creative Care Pharmacy, Hutton Pharmacy, Mustang Drug
- Study start
- 8 May 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- 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.
This study will evaluate the effectiveness of real-time data collected on patients taking topical medication to treat glaucoma. Patients will be randomized to two groups, the first of which will only use the study device to take their medication, while the second will use the study device and receive on-demand reminder messages, when necessary.
Detailed description
Adherence to topical medications to treat glaucoma remains sub optimal; however, our understanding of this behavior remains limited due to biased measures of medication use. The Kali Drop device is a potential improvement in our ability to capture medication use in patients using dropper bottles by precisely capturing the amount dispensed in real-time. Moreover, such technology creates data that can be leveraged into driving behavior change using connected mobile technology in order to improve adherence and, ultimately, health outcomes. While evidence suggests that reminders may improve adherence to glaucoma medications, the power of doing so using real-time data has yet to be explored. This study will compare simple monitoring of patients to those who are being monitored and who receive reminder messages when the system determines one is necessary due to a missed dose.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring only | Active comparator | Behavioral: Medication monitoring onlyPatients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months |
| Monitoring and reminder | Experimental | Behavioral: Medication reminderPatients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months and will receive an automated reminder (text or voice) when a missed dose is determined by the device's system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Glaucoma diagnosis
- Prescription for a prostaglandin indicated for glaucoma
- Nonadherent (MPR<80%) in the last 3 months according to pharmacy records
- Owns and operates a mobile phone and willing to receive periodic reminder messages
Key exclusion criteria (4 listed)
- Existing chronic eye condition in addition to glaucoma
- Scheduled for eye surgery in the next 90 days
- Prescription for a medication that will not fit in the device
- Non-English speaking
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 |
|---|---|---|
| Medication reminderUsing the real-time data capture of the electronic device, an automated voice call or text message will be sent to active arm participants only when a missed dose is determined | Behavioural | Monitoring and reminder |
| Medication monitoring onlyPatients will use an electronic medication monitoring device to record their actual medication use | Behavioural | Monitoring only |
Primary outcome
Adherence
Time frame: From study baseline through the 3 months of the intervention
Changes and differences in adherence to glaucoma medication between groups
Adherence follow-up
Time frame: From study endpoint through the subsequent 3 months
Changes and differences in adherence to glaucoma medication between groups after the intervention
1 secondary outcome
Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale
Time frame: Change from baseline over the 3-month intervention
Results and safety
The study was stopped early (reason given: Lack of sufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: No. No IPD
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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.
Justin Gatwood, PhD principal investigator
University of Tennessee
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication reminder and Medication monitoring only in people with Glaucoma, run by University of Tennessee at 8 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 was stopped early (reason given: Lack of sufficient recruitment). Results are not available in the source record.
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?
Adherence (time frame: From study baseline through the 3 months of the intervention). 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 7 Nov 2018.