Study on Incentives for Glaucoma Medications Adherence (SIGMA)
A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Singapore, Singapur
- Singapore National Eye Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Usual Care (UC)
Patients receiving Usual Care for Glaucoma comprising:
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Experimentální: Value Pricing (VP)
Patient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Monthly dose-rate adherence percentage
Časové okno: Month 6
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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.
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Month 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Dose-rate adherence percentage
Časové okno: Months 1 - 6
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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.
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Months 1 - 6
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Proportion meeting 90% dose-rate adherence percentage
Časové okno: Months 3 & 6
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The proportion of participants at each time point who met the 90% dose-rate adherence percentage cut-off for each monitoring period.
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Months 3 & 6
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Proportion meeting 75% dose-rate adherence percentage
Časové okno: Months 3 & 6
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The percentage of participants at each time point who met the 75% dose-rate adherence percentage cut-off for each monitoring period.
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Months 3 & 6
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Intraocular Pressure
Časové okno: Baseline & Month 6
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Intraocular Pressure measured using established protocols at SNEC.
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Baseline & Month 6
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EQ-5D-5L
Časové okno: Baseline & Month 6
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Scale to assess health related quality of life.
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Baseline & Month 6
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Glaucoma Quality of Life (GQL-15)
Časové okno: Baseline & Month 6
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Scale to measure quality of life, pertaining specifically to aspects of QoL that can be affected by the glaucoma condition.
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Baseline & Month 6
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Marcel Bilger, PhD, Duke-NUS Graduate Medical School
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HSRNIG12nov007
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