Study on Incentives for Glaucoma Medications Adherence
SIGMA
A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing
1 other identifier
interventional
100
1 country
1
Brief Summary
Glaucoma topical eye medications, when adhered to, are effective at controlling disease progression. Yet evidence shows that many glaucoma patients have incomplete adherence to medications, with disease progression resulting in significant costs to the patient and health system. Through the approach of value pricing, a link can be made between non-adherence and its resulting costs by granting subsidies to adherent patients for their medications and physician visits. This 6-month randomized controlled trial among 100 glaucoma patients from the Singapore National Eye Centre aims to test the extent to which value pricing can improve medication adherence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 1, 2017
April 1, 2017
2.2 years
October 19, 2014
April 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Monthly dose-rate adherence percentage
The proportion of days across a month where a patient took all medication(s) within the appropriate dosing windows (morning, afternoon, evening) for the day.
Month 6
Secondary Outcomes (6)
Dose-rate adherence percentage
Months 1 - 6
Proportion meeting 90% dose-rate adherence percentage
Months 3 & 6
Proportion meeting 75% dose-rate adherence percentage
Months 3 & 6
Intraocular Pressure
Baseline & Month 6
EQ-5D-5L
Baseline & Month 6
- +1 more secondary outcomes
Study Arms (2)
Usual Care (UC)
NO INTERVENTIONPatients receiving Usual Care for Glaucoma comprising: * Education on effective glaucoma treatment * Routine check-ups with an ophthalmologist and prescription of glaucoma eye drops * Glaucoma counselling \[Can be recommended by ophthalmologist for non-adherent patients\] covering: * Glaucoma risk factors and symptoms * Management and treatment * Medications and optimal dosage windows * Risks of medication non-adherence * Formulation of a dosing schedule that compliments each patient's lifestyle
Value Pricing (VP)
EXPERIMENTALPatient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.
Interventions
* Usual care for glaucoma * Subsidies granted to adherent patients for their glaucoma medications and physician visits, lowering the costs of treatment and providing a financial incentive for patients to take their medicines as prescribed. * Subsidy (25 / 50%) granted based on meeting dose-rate adherence percentage targets (75 / 90%) at the month 3 and 6 assessment points.
Eligibility Criteria
You may qualify if:
- Singaporean citizens or permanent residents
- Conversant in English or Mandarin
- Taking at least one glaucoma eye drop medication
- Shown to be non-adherent based on a value of 6 or less on the Modified Medication Adherence Scale (MMAS)
You may not qualify if:
- Significant comorbid conditions preventing application of medications without assistance
- Stage 4 (advanced) or Stage 5 (end stage) glaucoma according to the Glaucoma Staging System
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke-NUS Graduate Medical Schoollead
- Singapore National Eye Centrecollaborator
Study Sites (1)
Singapore National Eye Center
Singapore, Singapore
Related Publications (13)
Elliott RA, Shinogle JA, Peele P, Bhosle M, Hughes DA. Understanding medication compliance and persistence from an economics perspective. Value Health. 2008 Jul-Aug;11(4):600-10. doi: 10.1111/j.1524-4733.2007.00304.x. Epub 2008 Jan 8.
PMID: 18194403BACKGROUNDChapman GB, Brewer NT, Coups EJ, Brownlee S, Leventhal H, Leventhal EA. Value for the future and preventive health behavior. J Exp Psychol Appl. 2001 Sep;7(3):235-50.
PMID: 11676102BACKGROUNDvan Dulmen S, Sluijs E, van Dijk L, de Ridder D, Heerdink R, Bensing J. Patient adherence to medical treatment: a review of reviews. BMC Health Serv Res. 2007 Apr 17;7:55. doi: 10.1186/1472-6963-7-55.
PMID: 17439645BACKGROUNDHaynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.
PMID: 18425859BACKGROUNDGiuffrida A, Torgerson DJ. Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ. 1997 Sep 20;315(7110):703-7. doi: 10.1136/bmj.315.7110.703.
PMID: 9314754BACKGROUNDDiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9. doi: 10.1097/01.mlr.0000114908.90348.f9.
PMID: 15076819BACKGROUNDVolpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
PMID: 19102784BACKGROUNDMorisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
PMID: 18453793BACKGROUNDMills RP, Budenz DL, Lee PP, Noecker RJ, Walt JG, Siegartel LR, Evans SJ, Doyle JJ. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006 Jan;141(1):24-30. doi: 10.1016/j.ajo.2005.07.044.
PMID: 16386972BACKGROUNDHorne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4.
PMID: 10661603BACKGROUNDTsai 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.
PMID: 14520147BACKGROUNDBilger M, Wong TT, Lee JY, Howard KL, Bundoc FG, Lamoureux EL, Finkelstein EA. Using Adherence-Contingent Rebates on Chronic Disease Treatment Costs to Promote Medication Adherence: Results from a Randomized Controlled Trial. Appl Health Econ Health Policy. 2019 Dec;17(6):841-855. doi: 10.1007/s40258-019-00497-0.
PMID: 31317511DERIVEDBilger M, Wong TT, Howard KL, Lee JY, Toh AN, John G, Lamoureux EL, Finkelstein EA. Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing. Trials. 2016 Jul 15;17(1):316. doi: 10.1186/s13063-016-1459-1.
PMID: 27422389DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel Bilger, PhD
Duke-NUS Graduate Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 19, 2014
First Posted
October 22, 2014
Study Start
November 1, 2014
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
May 1, 2017
Record last verified: 2017-04