Medication AdherenceeyeGuideNCT03159247
The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program
A study testing eyeGuide in people with Medication Adherence and Glaucoma, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research study is to test the impact of two personalized technology based programs that may help improve adherence to glaucoma medications. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Medication Adherence, Glaucoma
- What is being tested?
- eyeGuide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2017to 10 Jan 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of glaucoma, glaucoma suspect or ocular hypertension
- Taking ≥ 1 glaucoma medication
- Age ≥ 40 years
- Non-adherent to glaucoma medications by both self-report and three months of electronic medication monitoring (adherence ≤ 80%)
Who cannot join
- Cognitive impairment
- Severe mental illness
- Do not administer own glaucoma medications
- Do not speak English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to test the impact of two personalized technology based programs that may help improve adherence to glaucoma medications.
Read the detailed description
Despite evidence from randomized clinical trials that medication reduces vision loss from glaucoma, it remains the second leading cause of blindness in the United States. A critical barrier to preventing vision loss is that about one-half of glaucoma patients are essentially "untreated" because they do not adhere to their medications. Ineffective self-management behaviors and poor clinical outcomes disproportionately affect the most vulnerable members of US society. The increased burden of glaucoma due to an aging US population, together with a projected shortage of ophthalmologists, will make team-based care essential. There is a critical need to develop and test team-based, personalized behavior change interventions for glaucoma patients to improve medication adherence and the outcomes of care.
Poor adherence to effective medications is a critical barrier to better outcomes in glaucoma patients. The World Health Organization stated that "increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments." Once diagnosed with glaucoma, at least half of patients do not adhere to their glaucoma medication regimen, return for follow-up, or persist with their medications over the longer term. Patients who are not adherent have more severe visual field loss, which leads to steep declines in health-related quality of life and increased risk of falls and motor vehicle accidents.
Adherence to glaucoma medications is rarely addressed during the clinical encounter because education and counseling programs are not part of standard glaucoma care. Focus groups have demonstrated that patients often have a poor understanding of glaucoma and its treatment. In addition to knowledge gaps, patients have numerous concrete and psychological barriers to managing their glaucoma. In addition, eye drop instillation is rarely taught, and many patients cannot properly instill their medications.
Uniform, scripted approaches to improve adherence do not work. However, complex, individualized counseling interventions, especially those based in motivational interviewing (MI), have improved adherence and health outcomes in many chronic diseases. MI is a style of counseling that engages patients by discussing priorities and obstacles to facilitate intrinsic motivation to change health behavior. Few complex interventions based on these successful principles have been rigorously tested and none implemented into glaucoma care. The eyeGuide is a web-based personally tailored behavior change program based on MI principles, a systematic review of the glaucoma adherence literature, and data from focus groups, surveys and iterative beta-testing with glaucoma patients. It provides individually tailored disease information and support to facilitate MI-based conversations between patients and paraprofessional staff to improve medication adherence. Such technology-based electronic health (eHealth) innovations have great potential to extend the reach of physicians by enabling team-based care.
In this pilot study, the study will test the impact of two personalized eHealth technologies on medication adherence among non-adherent glaucoma patients in a pre-post design: 1) real time automated adherence reminders; and 2) the eyeGuide counseling program. The study will explore the effects of these interventions on secondary outcomes including psychosocial mediators of adherence (e.g. motivation, self-efficacy, satisfaction), intraocular pressure (IOP), and IOP fluctuation.
- Conditions
- Medication Adherence, Glaucoma
- Being tested
- eyeGuide
- Keywords
- education, counseling, motivational interviewing, tailoring
- Medical subject headings
- Medication Adherence, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyeGuideBehavioural
The eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients.
| Study group | Role | What they receive |
|---|---|---|
| eyeGuide | Experimental | Two personalized eHealth interventions aimed to improve glaucoma medication adherence. Receives: Behavioral: eyeGuide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronically monitored glaucoma medication adherence
electronic medication monitoring
Measured: 22 months
Secondary outcomes (5)
Proportion of days covered with medication
monthly pharmacy refill data for glaucoma medications
Measured: 22 months
Change in self-reported medication adherence
Two survey instruments will be used to determine the amount of change in overall adherence
Measured: 22 months
Change in eye drop instillation technique
eye drop instillation technique will be video taped and analyzed on the 4 month and 8 month study visits
Measured: 4 months elapsed between 4 month and 8 month site visits
Change in Intra-ocular Pressure
Intra-ocular pressure will be measured by Goldmann applanation tonometry
Measured: 22 months
Change in Intra-ocular Pressure Fluctuation
Intraocular pressure data will be analyzed to assess a change in pressure fluctuations
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start12 Jan 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Model description
- This is a single group prospective behavioral intervention with a pre-post design. Adherence will be measured for three months at baseline, for an additional one month after an automated reminder system is initiated, for an additional six months during a personalized behavior change intervention and then for one year after the intervention.
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Research to Prevent Blindness, Henry Ford Health System
- Responsible party
- Principal investigator, Paula Anne Newman-Casey, University of Michigan
- Investigators
- Paula A Newman-Casey, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159247
- Sponsor's protocol ID
- HUM00112614
- Other IDs
- 1K23EY025320-01A1
- Acronym
- eyeGuide
- Status last verified
- Mar 2024
- First submitted
- 12 May 2017
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald RP, Xing W, Zeyen TG. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1295-304. doi: 10.1016/S0140-6736(14)62111-5. Epub 2014 Dec 19.
PubMed 25533656Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
PubMed 12365904Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940Olthoff CM, Schouten JS, van de Borne BW, Webers CA. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005 Jun;112(6):953-61. doi: 10.1016/j.ophtha.2004.12.035.
PubMed 15885795Reardon G, Kotak S, Schwartz GF. Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review. Patient Prefer Adherence. 2011;5:441-63. doi: 10.2147/PPA.S23780. Epub 2011 Sep 23.
PubMed 22003282Murakami Y, Lee BW, Duncan M, Kao A, Huang JY, Singh K, Lin SC. Racial and ethnic disparities in adherence to glaucoma follow-up visits in a county hospital population. Arch Ophthalmol. 2011 Jul;129(7):872-8. doi: 10.1001/archophthalmol.2011.163.
PubMed 21746977Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.
PubMed 15078664Lee PP, Hoskins HD Jr, Parke DW 3rd. Access to care: eye care provider workforce considerations in 2020. Arch Ophthalmol. 2007 Mar;125(3):406-10. doi: 10.1001/archopht.125.3.406. No abstract available.
PubMed 17353416Sabate E. Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization (WHO); 2003. Available at: http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf. Accessed June 7, 2015.
Kass MA, Gordon M, Morley RE Jr, Meltzer DW, Goldberg JJ. Compliance with topical timolol treatment. Am J Ophthalmol. 1987 Feb 15;103(2):188-93. doi: 10.1016/s0002-9394(14)74225-4.
PubMed 3812621Newman-Casey PA, Blachley T, Lee PP, Heisler M, Farris KB, Stein JD. Patterns of Glaucoma Medication Adherence over Four Years of Follow-Up. Ophthalmology. 2015 Oct;122(10):2010-21. doi: 10.1016/j.ophtha.2015.06.039. Epub 2015 Aug 25.
PubMed 26319441Rossi GC, Pasinetti GM, Scudeller L, Radaelli R, Bianchi PE. Do adherence rates and glaucomatous visual field progression correlate? Eur J Ophthalmol. 2011 Jul-Aug;21(4):410-4. doi: 10.5301/EJO.2010.6112.
PubMed 21140373Sleath B, Blalock S, Covert D, Stone JL, Skinner AC, Muir K, Robin AL. The relationship between glaucoma medication adherence, eye drop technique, and visual field defect severity. Ophthalmology. 2011 Dec;118(12):2398-402. doi: 10.1016/j.ophtha.2011.05.013.
PubMed 21856009Stewart WC, Chorak RP, Hunt HH, Sethuraman G. Factors associated with visual loss in patients with advanced glaucomatous changes in the optic nerve head. Am J Ophthalmol. 1993 Aug 15;116(2):176-81. doi: 10.1016/s0002-9394(14)71282-6.
PubMed 8352302McKean-Cowdin R, Varma R, Wu J, Hays RD, Azen SP; Los Angeles Latino Eye Study Group. Severity of visual field loss and health-related quality of life. Am J Ophthalmol. 2007 Jun;143(6):1013-23. doi: 10.1016/j.ajo.2007.02.022. Epub 2007 Apr 2.
PubMed 17399676
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program
- ClinicalTrials.gov ID
- NCT03159247
- Acronym / sponsor ID
- eyeGuide / HUM00112614
- Conditions
- Medication Adherence, Glaucoma
- Keywords
- education, counseling, motivational interviewing, tailoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Research to Prevent Blindness, Henry Ford Health System
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 18 May 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.
The purpose of this research study is to test the impact of two personalized technology based programs that may help improve adherence to glaucoma medications.
Detailed description
Despite evidence from randomized clinical trials that medication reduces vision loss from glaucoma, it remains the second leading cause of blindness in the United States. A critical barrier to preventing vision loss is that about one-half of glaucoma patients are essentially "untreated" because they do not adhere to their medications. Ineffective self-management behaviors and poor clinical outcomes disproportionately affect the most vulnerable members of US society. The increased burden of glaucoma due to an aging US population, together with a projected shortage of ophthalmologists, will make team-based care essential. There is a critical need to develop and test team-based, personalized behavior change interventions for glaucoma patients to improve medication adherence and the outcomes of care.
Poor adherence to effective medications is a critical barrier to better outcomes in glaucoma patients. The World Health Organization stated that "increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments." Once diagnosed with glaucoma, at least half of patients do not adhere to their glaucoma medication regimen, return for follow-up, or persist with their medications over the longer term. Patients who are not adherent have more severe visual field loss, which leads to steep declines in health-related quality of life and increased risk of falls and motor vehicle accidents.
Adherence to glaucoma medications is rarely addressed during the clinical encounter because education and counseling programs are not part of standard glaucoma care. Focus groups have demonstrated that patients often have a poor understanding of glaucoma and its treatment. In addition to knowledge gaps, patients have numerous concrete and psychological barriers to managing their glaucoma. In addition, eye drop instillation is rarely taught, and many patients cannot properly instill their medications.
Uniform, scripted approaches to improve adherence do not work. However, complex, individualized counseling interventions, especially those based in motivational interviewing (MI), have improved adherence and health outcomes in many chronic diseases. MI is a style of counseling that engages patients by discussing priorities and obstacles to facilitate intrinsic motivation to change health behavior. Few complex interventions based on these successful principles have been rigorously tested and none implemented into glaucoma care. The eyeGuide is a web-based personally tailored behavior change program based on MI principles, a systematic review of the glaucoma adherence literature, and data from focus groups, surveys and iterative beta-testing with glaucoma patients. It provides individually tailored disease information and support to facilitate MI-based conversations between patients and paraprofessional staff to improve medication adherence. Such technology-based electronic health (eHealth) innovations have great potential to extend the reach of physicians by enabling team-based care.
In this pilot study, the study will test the impact of two personalized eHealth technologies on medication adherence among non-adherent glaucoma patients in a pre-post design: 1) real time automated adherence reminders; and 2) the eyeGuide counseling program. The study will explore the effects of these interventions on secondary outcomes including psychosocial mediators of adherence (e.g. motivation, self-efficacy, satisfaction), intraocular pressure (IOP), and IOP fluctuation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group prospective behavioral intervention with a pre-post design. Adherence will be measured for three months at baseline, for an additional one month after an automated reminder system is initiated, for an additional six months during a personalized behavior change intervention and then for one year after the intervention.
| Arm | Type | Receives |
|---|---|---|
| eyeGuide | Experimental | Behavioral: eyeGuideTwo personalized eHealth interventions aimed to improve glaucoma medication adherence. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of glaucoma, glaucoma suspect or ocular hypertension
- Taking ≥ 1 glaucoma medication
- Age ≥ 40 years
- Non-adherent to glaucoma medications by both self-report and three months of electronic medication monitoring (adherence ≤ 80%)
Key exclusion criteria (4 listed)
- Cognitive impairment
- Severe mental illness
- Do not administer own glaucoma medications
- Do not speak English
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 |
|---|---|---|
| eyeGuideThe eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients. | Behavioural | eyeGuide |
Primary outcome
Electronically monitored glaucoma medication adherence
Time frame: 22 months
electronic medication monitoring
5 secondary outcomes
Proportion of days covered with medication
Time frame: 22 months
Change in self-reported medication adherence
Time frame: 22 months
Change in eye drop instillation technique
Time frame: 4 months elapsed between 4 month and 8 month site visits
Change in Intra-ocular Pressure
Time frame: 22 months
Change in Intra-ocular Pressure Fluctuation
Time frame: 22 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 19 Mar 2024.
- Background: PubMed 25533656Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald RP, Xing W, Zeyen TG. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1295-304. doi: 10.1016/S0140-6736(14)62111-5. Epub 2014 Dec 19.
- Background: PubMed 12365904Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
- Background: PubMed 16488940Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
- Background: PubMed 15885795Olthoff CM, Schouten JS, van de Borne BW, Webers CA. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005 Jun;112(6):953-61. doi: 10.1016/j.ophtha.2004.12.035.
- Background: PubMed 22003282Reardon G, Kotak S, Schwartz GF. Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review. Patient Prefer Adherence. 2011;5:441-63. doi: 10.2147/PPA.S23780. Epub 2011 Sep 23.
- Background: PubMed 21746977Murakami Y, Lee BW, Duncan M, Kao A, Huang JY, Singh K, Lin SC. Racial and ethnic disparities in adherence to glaucoma follow-up visits in a county hospital population. Arch Ophthalmol. 2011 Jul;129(7):872-8. doi: 10.1001/archophthalmol.2011.163.
- Background: PubMed 15078664Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.
- Background: PubMed 17353416Lee PP, Hoskins HD Jr, Parke DW 3rd. Access to care: eye care provider workforce considerations in 2020. Arch Ophthalmol. 2007 Mar;125(3):406-10. doi: 10.1001/archopht.125.3.406. No abstract available.
- BackgroundSabate E. Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization (WHO); 2003. Available at: http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf. Accessed June 7, 2015.
- Background: PubMed 3812621Kass MA, Gordon M, Morley RE Jr, Meltzer DW, Goldberg JJ. Compliance with topical timolol treatment. Am J Ophthalmol. 1987 Feb 15;103(2):188-93. doi: 10.1016/s0002-9394(14)74225-4.
- Background: PubMed 26319441Newman-Casey PA, Blachley T, Lee PP, Heisler M, Farris KB, Stein JD. Patterns of Glaucoma Medication Adherence over Four Years of Follow-Up. Ophthalmology. 2015 Oct;122(10):2010-21. doi: 10.1016/j.ophtha.2015.06.039. Epub 2015 Aug 25.
- Background: PubMed 21140373Rossi GC, Pasinetti GM, Scudeller L, Radaelli R, Bianchi PE. Do adherence rates and glaucomatous visual field progression correlate? Eur J Ophthalmol. 2011 Jul-Aug;21(4):410-4. doi: 10.5301/EJO.2010.6112.
- Individual participant dataSharing planned: No
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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.
Paula A Newman-Casey, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eyeGuide in people with Medication Adherence and Glaucoma, run by University of Michigan 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 4 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: finished, as of the sponsor's last update on 19 Mar 2024. 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?
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?
Electronically monitored glaucoma medication adherence (time frame: 22 months). 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 NCT03159247, which also lists 38 linked publications.
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 19 Mar 2024.