GlaucomaPhase 2NCT04317573
Effect on the Adherence to Glaucoma Eye Drops by Improving Patient Understanding and Using a Tele-reminder System
A Phase 2 study testing Personalised card in people with Glaucoma, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
To determine the improvement in patient adherence to topical ocular hypotensive therapy by introducing a personalised illustrated medication reference chart and tele-reminder. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Personalised card
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Oct 2018to 19 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who just started on glaucoma treatment
- Patients who are on less than 3 eyedrops
- Patients with vision worse than 6/60
Trial locations and contacts
1 site in 1 country.
About this study
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
To determine the improvement in patient adherence to topical ocular hypotensive therapy by introducing a personalised illustrated medication reference chart and tele-reminder.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Personalised card
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised cardDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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'. Receives: Device: Personalised card |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky Adherence Scale
Changes in mean adherence score based on Morisky Adherence Scale before and after intervention in participants from all 3 groups
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start19 Oct 2018
- Primary completion19 Oct 2019
- Study completion19 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Yien, National University Health System, Singapore
- Investigators
- Yien Lai, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317573
- Sponsor's protocol ID
- 2018/00289
- Other IDs
- 2018
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24974815Kass 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.
PubMed 12049574Heijl 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.
PubMed 12365904Loon 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.
PubMed 24248002Olthoff 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.
PubMed 15885795McDonald 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.
PubMed 12472329
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04317573
- Acronym / sponsor ID
- 2018/00289
- Conditions
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 19 Oct 2019 (actual)
- Study completion
- 19 Oct 2019 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Personalised card | Active comparator | Device: Personalised cardThe 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 |
| Personalised card and telereminder | Active comparator | Device: Personalised cardPatients 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 | No intervention | –No intervention |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who just started on glaucoma treatment
- Patients who are on less than 3 eyedrops
- Patients with vision worse than 6/60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised cardAn individualised card containing the patient's eye drops regime was printed for the patient after his/consult with the physician to be brought home. | Device | Personalised card, Personalised card and telereminder |
Primary outcome
Morisky Adherence Scale
Time frame: 6 weeks
Changes in mean adherence score based on Morisky Adherence Scale before and after intervention in participants from all 3 groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Results publication: PubMed 24974815Tham 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 publication: PubMed 12049574Kass 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 publication: PubMed 12365904Heijl 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 publication: PubMed 24248002Loon 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 publication: PubMed 15885795Olthoff 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 publication: PubMed 12472329McDonald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yien Lai, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalised card in people with Glaucoma, run by National University Health System, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morisky Adherence Scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317573, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.