Effect on the Adherence to Glaucoma Eye Drops by Improving Patient Understanding and Using a Tele-reminder System

NCT04317573 | Completed Phase 2

• 1 other identifier: 2018/00289
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the improvement in patient adherence to topical ocular hypotensive therapy by introducing a personalised illustrated medication reference chart and tele-reminder.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Morisky Adherence Scale

  Changes in mean adherence score based on Morisky Adherence Scale before and after intervention in participants from all 3 groups

  6 weeks

Study Arms (3)

Personalised card

ACTIVE COMPARATOR

The personalised card was printed by the attending ophthalmologist for the patient via a web accessible software we have developed. The software allowed the reviewing physician to select the medications the patient was prescribed and auto-generate a personalised card that will be sent to the network printer. The card illustrated the patient's eye drop regime in a simple pictorial format using coloured pictures of the eye drop bottles and universally recognised symbols. It can be folded to a compact size of 11cm x 7.5cm to allow patients to carry around in their wallets. This card will be given to patients at the end of their consult and explanation will be provided by the attending physician who will manually tick in the corresponding boxes depending on the frequency of administration

Device: Personalised card

Personalised card and telereminder

ACTIVE COMPARATOR

Patients who were recruited into the group receiving tele-monitoring were contacted via text messages daily by a programmed software at the scheduled time of eye drop administration. They were required to acknowledge the reminder by replying a 'Yes' if they had administered the eyedrop and 'No' if they had not. A nil reply was taken as a 'No'.

Device: Personalised card

No intervention

NO INTERVENTION

No intervention

Interventions

Personalised card DEVICE

An individualised card containing the patient's eye drops regime was printed for the patient after his/consult with the physician to be brought home.

Personalised card; Personalised card and telereminder

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been treated for glaucoma for at least 3 months
• Using a total of three or more eye drops, at least two of which are ocular hypotensive
• A minimum visual acuity of 6/60 or better
• Aged 30 to 90 years old

You may not qualify if:

• Patients who just started on glaucoma treatment
• Patients who are on less than 3 eyedrops
• Patients with vision worse than 6/60

Sponsors & Collaborators

• National University Health System, Singapore: lead

Study Sites (1)

Yien Lai

Singapore, 119074, Singapore

Location

Related Publications (6)

• Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

  PMID: 24974815 RESULT

• Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.

  PMID: 12049574 RESULT

• Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.

  PMID: 12365904 RESULT

• Loon SC, Jin J, Jin Goh M. The relationship between quality of life and adherence to medication in glaucoma patients in Singapore. J Glaucoma. 2015 Jun-Jul;24(5):e36-42. doi: 10.1097/IJG.0000000000000007.

  PMID: 24248002 RESULT

• Olthoff CM, Schouten JS, van de Borne BW, Webers CA. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005 Jun;112(6):953-61. doi: 10.1016/j.ophtha.2004.12.035.

  PMID: 15885795 RESULT

• McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. doi: 10.1001/jama.288.22.2868.

  PMID: 12472329 RESULT

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Yien Lai, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Model Details: A total of 59 patients were recruited for the study. Subjects were randomised into three groups: control (n=19), card only (n=20), card and tele-reminder (n=20) with an allocation ratio of 1:1:1. (Figure 1). Sample size was calculated based on similar drug adherence studies powered to detect a true difference in adherence rates with power at 80% and alpha at 5% - 20 patients per group were required.12,13

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 23, 2020
• Study Start: October 19, 2018
• Primary Completion: October 19, 2019
• Study Completion: October 19, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)