Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 7:02 AM
Study NCT ID:
NCT07488234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Glaucoma Awareness Program on Treatment Adherence
Sponsor:
Seva Canada Society
Organization:
Study Overview
Official Title:
Assessing the Impact of a Structured Glaucoma Awareness Program on Treatment Adherence Among Glaucoma Patients at Tertiary Eye Hospital in Nepal
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glaucoma is a leading cause of irreversible blindness worldwide, with a higher burden in low- and middle-income countries such as Nepal, where public awareness and treatment adherence remain poor. Lifelong adherence to treatment is important to prevent disease progression but still non adherence remains common.
This is a mixed method study which aims to evaluate the effectiveness of structured glaucoma awareness program in improving treatment adherence among glaucoma patients attending a tertiary eye hospital in Nepal. Quantitative assessment will measure changes in treatment adherence using Medication Adherence Scale at baseline and three months post intervention. A qualitative component will explore participants' perceptions of glaucoma program and suggestions for improvement through semi-structured interviews.
This is a mixed method study which aims to evaluate the effectiveness of structured glaucoma awareness program in improving treatment adherence among glaucoma patients attending a tertiary eye hospital in Nepal. Quantitative assessment will measure changes in treatment adherence using Medication Adherence Scale at baseline and three months post intervention. A qualitative component will explore participants' perceptions of glaucoma program and suggestions for improvement through semi-structured interviews.
Detailed Description:
A mixed method interventional study will be conducted to assess the impact of a structured glaucoma awareness program on treatment adherence among the glaucoma follow-up patients attending a tertiary eye hospital in Nepal. The total study duration will be 10 months including preparation, participant recruitment, awareness program and follow up after 3 months, data analysis and reporting.
The primary objective of this study is to compare the treatment adherence scores of glaucoma patients before and three months after participation in the glaucoma awareness program.
The secondary objective is to qualitatively explore the participants' perceptions of the awareness program, identify barriers to treatment adherence and get the suggestions for improving patient education.
Patient ≥18 years with pre-existing diagnosis of glaucoma attending routine follow up visits will be invited to participate. All the eligible patients who meet the inclusion criteria will be selected. A formal sample size calculation will be performed prior to recruitment. Based on prior literature, a target sample size of approximately 60 participants is anticipated to provide adequate statistical power. After obtaining a written informed consent, participants will complete a baseline self-reported questionnaire assessing demographics and treatment adherence using the validated medication adherence scale.
Participants will then attend a structured 30-minute glaucoma awareness program consisting of a PowerPoint presentation covering foundational concepts of glaucoma and related risk factors, disease progression, and the importance of treatment adherence. An illustrated one-page informational leaflet in simple Nepali will be distributed to all participants. An interactive question-and-answer session will be conducted to respond to queries. To ensure the program is inclusive and accessible for glaucoma patients with visual impairment, power point slides and leaflets will use large fonts, high contrast and simple illustration. Key messages and visual content will be reinforced verbally. Participants will be encouraged to ask questions and clarification will be provided as needed.
At three months post-intervention, same participants will be contacted by telephone by the principle investigator to reassess treatment adherence using the same validated tools. Quantitative data will be analyzed using paired statistical tests to compare pre- and post-intervention outcomes.
A selected sub sample of approximately 8 - 10 participants will undergo semi-structured qualitative interviews three months after the awareness program, to explore their experiences with the awareness program, perceived benefits, barriers to implementing learned behaviors, and recommendations for improvement. Interviews will be audio-recorded, transcribed verbatim, translated into English, and analyzed using thematic analysis.
The study will receive approval from NHRC. Confidentiality will be maintained through anonymization of data, and participants may withdraw at any time without impact on their medical care.
The primary objective of this study is to compare the treatment adherence scores of glaucoma patients before and three months after participation in the glaucoma awareness program.
The secondary objective is to qualitatively explore the participants' perceptions of the awareness program, identify barriers to treatment adherence and get the suggestions for improving patient education.
Patient ≥18 years with pre-existing diagnosis of glaucoma attending routine follow up visits will be invited to participate. All the eligible patients who meet the inclusion criteria will be selected. A formal sample size calculation will be performed prior to recruitment. Based on prior literature, a target sample size of approximately 60 participants is anticipated to provide adequate statistical power. After obtaining a written informed consent, participants will complete a baseline self-reported questionnaire assessing demographics and treatment adherence using the validated medication adherence scale.
Participants will then attend a structured 30-minute glaucoma awareness program consisting of a PowerPoint presentation covering foundational concepts of glaucoma and related risk factors, disease progression, and the importance of treatment adherence. An illustrated one-page informational leaflet in simple Nepali will be distributed to all participants. An interactive question-and-answer session will be conducted to respond to queries. To ensure the program is inclusive and accessible for glaucoma patients with visual impairment, power point slides and leaflets will use large fonts, high contrast and simple illustration. Key messages and visual content will be reinforced verbally. Participants will be encouraged to ask questions and clarification will be provided as needed.
At three months post-intervention, same participants will be contacted by telephone by the principle investigator to reassess treatment adherence using the same validated tools. Quantitative data will be analyzed using paired statistical tests to compare pre- and post-intervention outcomes.
A selected sub sample of approximately 8 - 10 participants will undergo semi-structured qualitative interviews three months after the awareness program, to explore their experiences with the awareness program, perceived benefits, barriers to implementing learned behaviors, and recommendations for improvement. Interviews will be audio-recorded, transcribed verbatim, translated into English, and analyzed using thematic analysis.
The study will receive approval from NHRC. Confidentiality will be maintained through anonymization of data, and participants may withdraw at any time without impact on their medical care.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: