GlaucomaSIGMANCT02271269
Study on Incentives for Glaucoma Medications Adherence
A study testing Value Pricing Subsidies in people with Glaucoma, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Value Pricing Subsidies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2014to Feb 2017
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Significant comorbid conditions preventing application of medications without assistance
- Stage 4 (advanced) or Stage 5 (end stage) glaucoma according to the Glaucoma Staging System
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing
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.
Read the detailed description
By reducing intraocular pressure, glaucoma topical eye medications are effective at controlling disease progression for the majority of patients. Yet evidence shows that many glaucoma patients have incomplete adherence to medications, resulting in significant personal costs in terms of disease progression and visual field loss. The cost to the health system from poor adherence is also substantial as glaucoma surgery is more costly than treatment with topical medication. Behavioural economics theory suggests that adherence rates can be improved by providing a clearer link between non-adherence and the resulting costs thereof. In the proposed study, this link is made by granting subsidies to adherent patients for their medications and physician visits, whereas those who are not sufficiently adherent would not receive the subsidy and thus pay a higher rate for their treatment.
These subsidies provide a financial incentive for patients to take their medicines as prescribed, and because prescription refills and visits occur regularly, also provide a tangible and near-term cost resulting from non-adherence. The investigators refer to this approach as value pricing as subsidies are allocated to medications that have not only been shown to be clinically effective but that are also effectively used by the patient. In efforts to increase adherence among glaucoma patients in Singapore, the investigators propose to conduct a 6-month proof-of-concept randomized controlled trial among 100 participants from the Singapore National Eye Centre (SNEC) to test the extent to which value pricing can improve medication adherence. As Singapore's population continues to age and a larger share of the population requires daily medications to treat chronic diseases, such innovative solutions are needed to ensure not only that patients take their medications as prescribed and receive the full benefit of their treatment but also that Government subsidies are allocated effectively so that to ensure the sustainability of the health system.
Specific Aim and hypothesis tested:
Aim: Test whether adding Value Pricing (VP) to Usual Care (UC) can improve medication adherence over a 6-month period.
Hypothesis: VP patients will show greater adherence rates at 6 months compared to those receiving only UC.
- Conditions
- Glaucoma
- Being tested
- Value Pricing Subsidies
- Keywords
- glaucoma, medication adherence, financial incentives, behavioral economics
- Medical subject headings
- Glaucoma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Value Pricing SubsidiesBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Value Pricing Subsidies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (6)
Dose-rate adherence percentage
The proportion of days across the study period where a patient took all medication(s) within the appropriate dosing windows (morning, afternoon, evening) for the day.
Measured: Months 1 - 6
Proportion meeting 90% dose-rate adherence percentage
The proportion of participants at each time point who met the 90% dose-rate adherence percentage cut-off for each monitoring period.
Measured: Months 3 & 6
Proportion meeting 75% dose-rate adherence percentage
The percentage of participants at each time point who met the 75% dose-rate adherence percentage cut-off for each monitoring period.
Measured: Months 3 & 6
Intraocular Pressure
Intraocular Pressure measured using established protocols at SNEC.
Measured: Baseline & Month 6
EQ-5D-5L
Scale to assess health related quality of life.
Measured: Baseline & Month 6
Glaucoma Quality of Life (GQL-15)
Scale to measure quality of life, pertaining specifically to aspects of QoL that can be affected by the glaucoma condition.
Measured: Baseline & Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore National Eye Centre
- Responsible party
- Principal investigator, Marcel Bilger, Duke-NUS Graduate Medical School
- Investigators
- Marcel Bilger, PhD, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271269
- Sponsor's protocol ID
- HSRNIG12nov007
- Acronym
- SIGMA
- Status last verified
- Apr 2017
- First submitted
- 19 Oct 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18194403Chapman 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.
PubMed 11676102van 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.
PubMed 17439645Haynes 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.
PubMed 18425859Giuffrida 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.
PubMed 9314754DiMatteo 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.
PubMed 15076819Volpp 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.
PubMed 19102784Morisky 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.
PubMed 18453793Mills 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.
PubMed 16386972Horne 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.
PubMed 10661603Tsai 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.
PubMed 14520147Bilger 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.
PubMed 31317511Bilger 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.
PubMed 27422389
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing
- ClinicalTrials.gov ID
- NCT02271269
- Acronym / sponsor ID
- SIGMA / HSRNIG12nov007
- Conditions
- Glaucoma
- Keywords
- glaucoma, medication adherence, financial incentives, behavioral economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Singapore National Eye Centre
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Oct 2014 (estimated)
- 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.
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.
Detailed description
By reducing intraocular pressure, glaucoma topical eye medications are effective at controlling disease progression for the majority of patients. Yet evidence shows that many glaucoma patients have incomplete adherence to medications, resulting in significant personal costs in terms of disease progression and visual field loss. The cost to the health system from poor adherence is also substantial as glaucoma surgery is more costly than treatment with topical medication. Behavioural economics theory suggests that adherence rates can be improved by providing a clearer link between non-adherence and the resulting costs thereof. In the proposed study, this link is made by granting subsidies to adherent patients for their medications and physician visits, whereas those who are not sufficiently adherent would not receive the subsidy and thus pay a higher rate for their treatment.
These subsidies provide a financial incentive for patients to take their medicines as prescribed, and because prescription refills and visits occur regularly, also provide a tangible and near-term cost resulting from non-adherence. The investigators refer to this approach as value pricing as subsidies are allocated to medications that have not only been shown to be clinically effective but that are also effectively used by the patient. In efforts to increase adherence among glaucoma patients in Singapore, the investigators propose to conduct a 6-month proof-of-concept randomized controlled trial among 100 participants from the Singapore National Eye Centre (SNEC) to test the extent to which value pricing can improve medication adherence. As Singapore's population continues to age and a larger share of the population requires daily medications to treat chronic diseases, such innovative solutions are needed to ensure not only that patients take their medications as prescribed and receive the full benefit of their treatment but also that Government subsidies are allocated effectively so that to ensure the sustainability of the health system.
Specific Aim and hypothesis tested:
Aim: Test whether adding Value Pricing (VP) to Usual Care (UC) can improve medication adherence over a 6-month period.
Hypothesis: VP patients will show greater adherence rates at 6 months compared to those receiving only UC.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Value Pricing SubsidiesPatient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Significant comorbid conditions preventing application of medications without assistance
- Stage 4 (advanced) or Stage 5 (end stage) glaucoma according to the Glaucoma Staging System
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 |
|---|---|---|
| Value Pricing Subsidies* 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. | Behavioural | Value Pricing (VP) |
Primary outcome
Monthly dose-rate adherence percentage
Time frame: Month 6
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.
6 secondary outcomes
Dose-rate adherence percentage
Time frame: Months 1 - 6
Proportion meeting 90% dose-rate adherence percentage
Time frame: Months 3 & 6
Proportion meeting 75% dose-rate adherence percentage
Time frame: Months 3 & 6
Intraocular Pressure
Time frame: Baseline & Month 6
EQ-5D-5L
Time frame: Baseline & Month 6
Glaucoma Quality of Life (GQL-15)
Time frame: Baseline & Month 6
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 1 May 2017.
- Background: PubMed 18194403Elliott 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.
- Background: PubMed 11676102Chapman 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.
- Background: PubMed 17439645van 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.
- Background: PubMed 18425859Haynes 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.
- Background: PubMed 9314754Giuffrida 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.
- Background: PubMed 15076819DiMatteo 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.
- Background: PubMed 19102784Volpp 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.
- Background: PubMed 18453793Morisky 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.
- Background: PubMed 16386972Mills 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.
- Background: PubMed 10661603Horne 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.
- Background: PubMed 14520147Tsai 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.
- Derived from this study: PubMed 31317511Bilger 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.
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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.
Marcel Bilger, PhD principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Value Pricing Subsidies in people with Glaucoma, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 2 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 1 May 2017. 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 Singapore. 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?
Monthly dose-rate adherence percentage (time frame: Month 6). 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 NCT02271269, which also lists 13 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 1 May 2017.