The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program

Glaucoma Clinical Trial

— eyeGuide  

Official title:

The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159247
• Other study ID #: HUM00112614
• Secondary ID: 1K23EY025320-01A
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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%)

Exclusion Criteria:

• Cognitive impairment

• Severe mental illness

• Do not administer own glaucoma medications

• Do not speak English

Related Conditions & MeSH terms

• Glaucoma
• Medication Adherence

Intervention

Behavioral:
• eyeGuide
The eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Henry Ford Health System, National Eye Institute (NEI), Research to Prevent Blindness

Country where clinical trial is conducted

United States, 

References & Publications (35)

Congdon 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. — View Citation

Freeman EE, Munoz B, West SK, Jampel HD, Friedman DS. Glaucoma and quality of life: the Salisbury Eye Evaluation. Ophthalmology. 2008 Feb;115(2):233-8. doi: 10.1016/j.ophtha.2007.04.050. Epub 2007 Jul 26. — View Citation

Friedman DS, Hahn SR, Gelb L, Tan J, Shah SN, Kim EE, Zimmerman TJ, Quigley HA. Doctor-patient communication, health-related beliefs, and adherence in glaucoma results from the Glaucoma Adherence and Persistency Study. Ophthalmology. 2008 Aug;115(8):1320-7, 1327.e1-3. doi: 10.1016/j.ophtha.2007.11.023. Epub 2008 Mar 5. — View Citation

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. Erratum In: Lancet. 2015 Jul 11;386(9989):136. — View Citation

Haymes SA, Leblanc RP, Nicolela MT, Chiasson LA, Chauhan BC. Risk of falls and motor vehicle collisions in glaucoma. Invest Ophthalmol Vis Sci. 2007 Mar;48(3):1149-55. doi: 10.1167/iovs.06-0886. — View Citation

Heijl 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. — View Citation

Hennessy AL, Katz J, Covert D, Kelly CA, Suan EP, Speicher MA, Sund NJ, Robin AL. A video study of drop instillation in both glaucoma and retina patients with visual impairment. Am J Ophthalmol. 2011 Dec;152(6):982-8. doi: 10.1016/j.ajo.2011.05.015. Epub 2011 Aug 6. — View Citation

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. — View Citation

Lacey J, Cate H, Broadway DC. Barriers to adherence with glaucoma medications: a qualitative research study. Eye (Lond). 2009 Apr;23(4):924-32. doi: 10.1038/eye.2008.103. Epub 2008 Apr 25. — View Citation

Lee 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. — View Citation

Lunnela J, Kaariainen M, Kyngas H. The views of compliant glaucoma patients on counselling and social support. Scand J Caring Sci. 2010 Sep;24(3):490-8. doi: 10.1111/j.1471-6712.2009.00739.x. — View Citation

McKean-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. — View Citation

McKean-Cowdin R, Wang Y, Wu J, Azen SP, Varma R; Los Angeles Latino Eye Study Group. Impact of visual field loss on health-related quality of life in glaucoma: the Los Angeles Latino Eye Study. Ophthalmology. 2008 Jun;115(6):941-948.e1. doi: 10.1016/j.ophtha.2007.08.037. Epub 2007 Nov 12. — View Citation

Miller WR and Rollnick S. Motivational Interviewing: Helping people change, 3rd edition. 2013; Guilford Press, New York, NY.

Murakami 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. — View Citation

Newman-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. — View Citation

Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24. — View Citation

Newman-Casey PA, Shtein RM, Coleman AL, Herndon L, Lee PP. Why Patients With Glaucoma Lose Vision: The Patient Perspective. J Glaucoma. 2016 Jul;25(7):e668-75. doi: 10.1097/IJG.0000000000000320. — View Citation

Newman-Casey PA, Weizer JS, Heisler M, Lee PP, Stein JD. Systematic review of educational interventions to improve glaucoma medication adherence. Semin Ophthalmol. 2013 May;28(3):191-201. doi: 10.3109/08820538.2013.771198. — View Citation

Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, Sivaramalingam B, Iserman E, Mustafa RA, Jedraszewski D, Cotoi C, Haynes RB. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4. — View Citation

Olthoff 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. — View Citation

Quigley 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. — View Citation

Reardon 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. — View Citation

Rossi 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. — View Citation

Sabate 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.

Sleath 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. — View Citation

Sleath B, Blalock SJ, Carpenter DM, Sayner R, Muir KW, Slota C, Lawrence SD, Giangiacomo AL, Hartnett ME, Tudor G, Goldsmith JA, Robin AL. Ophthalmologist-patient communication, self-efficacy, and glaucoma medication adherence. Ophthalmology. 2015 Apr;122(4):748-54. doi: 10.1016/j.ophtha.2014.11.001. Epub 2014 Dec 24. — View Citation

Sleath B, Blalock SJ, Stone JL, Skinner AC, Covert D, Muir K, Robin AL. Validation of a short version of the glaucoma medication self-efficacy questionnaire. Br J Ophthalmol. 2012 Feb;96(2):258-62. doi: 10.1136/bjo.2010.199851. Epub 2011 May 24. — View Citation

Sleath BL, Blalock SJ, Muir KW, Carpenter DM, Lawrence SD, Giangiacomo AL, Goldsmith JA, Hartnett ME, Slota C, Robin AL. Determinants of Self-Reported Barriers to Glaucoma Medicine Administration and Adherence: A Multisite Study. Ann Pharmacother. 2014 Jul;48(7):856-862. doi: 10.1177/1060028014529413. Epub 2014 Apr 1. — View Citation

Stewart 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. — View Citation

Stryker JE, Beck AD, Primo SA, Echt KV, Bundy L, Pretorius GC, Glanz K. An exploratory study of factors influencing glaucoma treatment adherence. J Glaucoma. 2010 Jan;19(1):66-72. doi: 10.1097/IJG.0b013e31819c4679. — View Citation

Taylor SA, Galbraith SM, Mills RP. Causes of non-compliance with drug regimens in glaucoma patients: a qualitative study. J Ocul Pharmacol Ther. 2002 Oct;18(5):401-9. doi: 10.1089/10807680260362687. — View Citation

Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003 Oct;12(5):393-8. doi: 10.1097/00061198-200310000-00001. — View Citation

Varma R, Wu J, Chong K, Azen SP, Hays RD; Los Angeles Latino Eye Study Group. Impact of severity and bilaterality of visual impairment on health-related quality of life. Ophthalmology. 2006 Oct;113(10):1846-53. doi: 10.1016/j.ophtha.2006.04.028. Epub 2006 Aug 4. — View Citation

Waterman H, Evans JR, Gray TA, Henson D, Harper R. Interventions for improving adherence to ocular hypotensive therapy. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD006132. doi: 10.1002/14651858.CD006132.pub3. — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electronically monitored glaucoma medication adherence	electronic medication monitoring	22 months
Secondary	Proportion of days covered with medication	monthly pharmacy refill data for glaucoma medications	22 months
Secondary	Change in self-reported medication adherence	Two survey instruments will be used to determine the amount of change in overall adherence	22 months
Secondary	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	4 months elapsed between 4 month and 8 month site visits
Secondary	Change in Intra-ocular Pressure	Intra-ocular pressure will be measured by Goldmann applanation tonometry	22 months
Secondary	Change in Intra-ocular Pressure Fluctuation	Intraocular pressure data will be analyzed to assess a change in pressure fluctuations	22 months