| CTRI Number |
CTRI/2024/09/073433 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Glaucoma Medication Adherence Study |
|
Scientific Title of Study
|
Assessment of the role of regular text messages, audio-visual reminders using adherence monitors, and one on one counselling on the adherence to topical medications in patients with glaucoma - A non-randomized study |
| Trial Acronym |
AGMAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Upadhyaya |
| Designation |
Consultant |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No. 21, First floor, Glaucoma Clinic,
Aravind Eye Hospital
Thavalakuppam
Cuddalore Main road
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
- |
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Upadhyaya |
| Designation |
Consultant |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No. 21, First floor, Glaucoma Clinic,
Aravind Eye Hospital
Thavalakuppam
Cuddalore Main road
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
- |
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Swati Upadhyaya |
| Designation |
Consultant |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No. 21, First floor, Glaucoma Clinic,
Aravind Eye Hospital
Thavalakuppam
Cuddalore Main road
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
- |
| Email |
swati.dr@aravind.org |
|
|
Source of Monetary or Material Support
|
| W K Kellogg Eye Centre, Ann Arbor, Michigan |
|
|
Primary Sponsor
|
| Name |
W K Kellogg Eye Centre, Michigan |
| Address |
1000 Wall St, Ann Arbor, Michigan, 48109 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swati Upadhyaya |
Aravind Eye Hospital, Pondicherry |
Thavalakuppam, Cuddalore Main Road
Pondicherry
PONDICHERRY |
8489810704
swati.dr@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
as |
|
| ExclusionCriteria |
| Details |
1. Newly diagnosed patients with glaucoma
2. Glaucoma patients with uncontrolled IOP
3. Glaucoma patients who are not on stable medications
4. Ocular hypertension (OHT)
5. Normal tension glaucoma
6. Secondary glaucomas like immediate post-surgical, steroid induced which might not need long term anti-glaucoma medications
7. History of intraocular surgery within the previous 3 months
8. People with cognitive decline – BCVA in the better eye less than 6/60, poor hearing requiring hearing aids
9. Illiterate patients
10. Pregnant / nursing mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the change in mean adherence from baseline following regular text messages, audio-visual reminders using adherence monitors and counselling
2. To assess the proportion of participants with improved adherence from baseline following regular text messages, audio-visual reminders using adherence monitors and counselling
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the barriers for adherence based on a survey questionnaire
2. To assess the participant feedback regarding the three methods of intervention - regular text messages, audio-visual reminders using adherence monitors and counselling using a feedback form
3. To assess whether there is an incremental response in adherence when multiple methods are used sequentially
4. To assess the proportion of participants with ≥80% adherence
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
High rates of poor adherence to effective medications is a key modifiable barrier to better outcomes for people with glaucoma. Various methods to modify the adherence that have been described in literature including patient education interventions, counselling, personalized glaucoma coaching programs, giving written instructions, reminder systems, rescheduling of eye drop therapy with simplification of dosing, eye drop instillation training, creation of a glaucoma club among others. Through this study, we aim to assess the benefit of regular text messages, audio-visual reminders using adherence monitors and counselling on the adherence to topical medications in patients with glaucoma in a south Indian population. We hypothesize that the adherence to topical anti-glaucoma medications would improve by providing reminders or intensive counselling sessions to the participants. A reminder text message service if found beneficial, may also be provided by subscription to the patients in the future. |