Study on Incentives for Glaucoma Medications Adherence (SIGMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02271269|
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Behavioral: Value Pricing Subsidies||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||February 2017|
No Intervention: Usual Care (UC)
Patients receiving Usual Care for Glaucoma comprising:
Experimental: Value Pricing (VP)
Patient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.
Behavioral: Value Pricing Subsidies
- 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.
- Dose-rate adherence percentage [ Time Frame: Months 1 - 6 ]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.
- Proportion meeting 90% dose-rate adherence percentage [ Time Frame: Months 3 & 6 ]The proportion of participants at each time point who met the 90% dose-rate adherence percentage cut-off for each monitoring period.
- Proportion meeting 75% dose-rate adherence percentage [ Time Frame: Months 3 & 6 ]The percentage of participants at each time point who met the 75% dose-rate adherence percentage cut-off for each monitoring period.
- Intraocular Pressure [ Time Frame: Baseline & Month 6 ]Intraocular Pressure measured using established protocols at SNEC.
- EQ-5D-5L [ Time Frame: Baseline & Month 6 ]Scale to assess health related quality of life.
- Glaucoma Quality of Life (GQL-15) [ Time Frame: Baseline & Month 6 ]Scale to measure quality of life, pertaining specifically to aspects of QoL that can be affected by the glaucoma condition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271269
|Singapore National Eye Center|
|Principal Investigator:||Marcel Bilger, PhD||DUKE NUS Graduate Medical School Singapore|