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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Personalised card
Sponsored by
National University Health System, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Yien Lai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Personalised card

Personalised card and telereminder

No intervention

Arm Description

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

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'.

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 16, 2020
Last Updated
March 19, 2020
Sponsor
National University Health System, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04317573
Brief Title
Effect on the Adherence to Glaucoma Eye Drops by Improving Patient Understanding and Using a Tele-reminder System
Official Title
Effect on the Adherence to Glaucoma Eye Drops by Improving Patient Understanding and Using a Tele-reminder System: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
October 19, 2019 (Actual)
Study Completion Date
October 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a randomized controlled clinical trial study with patients recruited from the National University Hospital, Singapore who met eligibility criteria and agreed to participate in the study during their regularly scheduled outpatient visits. Written informed consent was obtained after the nature of the study had been fully explained to the patient. Recruitment took place from October 2018 to October 2019. The study received the local Institutional Review Board approval and all procedures are in accordance with the ethical standards as stated in the Helsinki Declaration. 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. 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. 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'. Trained research assistants and a medical student administered the pre-implementation baseline adherence questionnaire in-person after informed consent was obtained. The questionnaire included questions on (i) demographics (ii) barriers to adherence and (iii) Morisky adherence scale. The demographic information included age, gender, length of time using glaucoma medications, number of glaucoma medications, educational level, whether they identify the medications by name or colour and who helps with the eye drop instillation. In the second section on barriers to adherence, participants were asked to use a visual analogue scale to rate the importance of 11 commonly cited reasons that make it "hard for patients to take glaucoma eye drops." The visual analog scale had 5 major hatch marks anchored between "strongly disagree" and "strongly agree." In the third section of the questionnaire, participants completed the Morisky Adherence Scale, a validated instrument for measuring self-reported adherence which was targeted for glaucoma medications in this study. The interventions in both the card and tele-reminder groups were administered for a period of 6 weeks, following which a post-implementation adherence questionnaire was conducted via a telephone call by the same research assistants and medical student. The questionnaire included the same questions on the Morisky adherence scale as per the pre-implementation questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalised card
Arm Type
Active Comparator
Arm Description
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
Arm Title
Personalised card and telereminder
Arm Type
Active Comparator
Arm Description
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'.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
Personalised card
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morisky Adherence Scale
Description
Changes in mean adherence score based on Morisky Adherence Scale before and after intervention in participants from all 3 groups
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients who just started on glaucoma treatment Patients who are on less than 3 eyedrops Patients with vision worse than 6/60
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yien Lai, MBBS
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yien Lai
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24974815
Citation
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.
Results Reference
result
PubMed Identifier
12049574
Citation
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.
Results Reference
result
PubMed Identifier
12365904
Citation
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.
Results Reference
result
PubMed Identifier
24248002
Citation
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.
Results Reference
result
PubMed Identifier
15885795
Citation
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.
Results Reference
result
PubMed Identifier
12472329
Citation
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. Erratum In: JAMA. 2003 Jun 25;289(24):3242.
Results Reference
result

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

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