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Study on Incentives for Glaucoma Medications Adherence (SIGMA)

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Value Pricing Subsidies
Sponsored by
Duke-NUS Graduate Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Glaucoma focused on measuring glaucoma, medication adherence, financial incentives, behavioral economics

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Significant comorbid conditions preventing application of medications without assistance
  • Stage 4 (advanced) or Stage 5 (end stage) glaucoma according to the Glaucoma Staging System

Sites / Locations

  • Singapore National Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care (UC)

Value Pricing (VP)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Intraocular Pressure
Intraocular Pressure measured using established protocols at SNEC.
EQ-5D-5L
Scale to assess health related quality of life.
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.

Full Information

First Posted
October 19, 2014
Last Updated
April 28, 2017
Sponsor
Duke-NUS Graduate Medical School
Collaborators
Singapore National Eye Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02271269
Brief Title
Study on Incentives for Glaucoma Medications Adherence
Acronym
SIGMA
Official Title
A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke-NUS Graduate Medical School
Collaborators
Singapore National Eye Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, medication adherence, financial incentives, behavioral economics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
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
Arm Title
Value Pricing (VP)
Arm Type
Experimental
Arm Description
Patient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.
Intervention Type
Behavioral
Intervention Name(s)
Value Pricing Subsidies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Monthly dose-rate adherence percentage
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Dose-rate adherence percentage
Description
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.
Time Frame
Months 1 - 6
Title
Proportion meeting 90% dose-rate adherence percentage
Description
The proportion of participants at each time point who met the 90% dose-rate adherence percentage cut-off for each monitoring period.
Time Frame
Months 3 & 6
Title
Proportion meeting 75% dose-rate adherence percentage
Description
The percentage of participants at each time point who met the 75% dose-rate adherence percentage cut-off for each monitoring period.
Time Frame
Months 3 & 6
Title
Intraocular Pressure
Description
Intraocular Pressure measured using established protocols at SNEC.
Time Frame
Baseline & Month 6
Title
EQ-5D-5L
Description
Scale to assess health related quality of life.
Time Frame
Baseline & Month 6
Title
Glaucoma Quality of Life (GQL-15)
Description
Scale to measure quality of life, pertaining specifically to aspects of QoL that can be affected by the glaucoma condition.
Time Frame
Baseline & Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Significant comorbid conditions preventing application of medications without assistance Stage 4 (advanced) or Stage 5 (end stage) glaucoma according to the Glaucoma Staging System
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel Bilger, PhD
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore National Eye Center
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
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Citation
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Results Reference
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Study on Incentives for Glaucoma Medications Adherence

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