NCT02271269

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

October 19, 2014

Last Update Submit

April 28, 2017

Conditions

Keywords

glaucomamedication adherencefinancial incentivesbehavioral economics

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 INTERVENTION

Patients 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)

EXPERIMENTAL

Patient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.

Behavioral: 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.

Value Pricing (VP)

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Singapore National Eye Center

Singapore, Singapore

Location

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: 18194403BACKGROUND
  • Chapman 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: 11676102BACKGROUND
  • van 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: 17439645BACKGROUND
  • Haynes 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: 18425859BACKGROUND
  • Giuffrida 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: 9314754BACKGROUND
  • DiMatteo 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: 15076819BACKGROUND
  • Volpp 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: 19102784BACKGROUND
  • Morisky 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: 18453793BACKGROUND
  • Mills 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: 16386972BACKGROUND
  • Horne 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: 10661603BACKGROUND
  • 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.

    PMID: 14520147BACKGROUND
  • Bilger 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.

  • Bilger 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.

MeSH Terms

Conditions

GlaucomaMedication Adherence

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Marcel Bilger, PhD

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

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

Locations