Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Singapore National Eye Centre
Information provided by (Responsible Party):
Marcel Bilger, Duke-NUS Graduate Medical School

Tracking Information
First Submitted Date  ICMJE October 19, 2014
First Posted Date  ICMJE October 22, 2014
Last Update Posted Date May 1, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02271269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Incentives for Glaucoma Medications Adherence
Official Title  ICMJE A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Glaucoma
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • No Intervention: Usual Care (UC)

    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
  • Experimental: Value Pricing (VP)
    Patient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.
    Intervention: Behavioral: Value Pricing Subsidies
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02271269
Other Study ID Numbers  ICMJE HSRNIG12nov007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marcel Bilger, Duke-NUS Graduate Medical School
Study Sponsor  ICMJE Duke-NUS Graduate Medical School
Collaborators  ICMJE Singapore National Eye Centre
Investigators  ICMJE
Principal Investigator: Marcel Bilger, PhD Duke-NUS Graduate Medical School
PRS Account Duke-NUS Graduate Medical School
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP