- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488234
Impact of a Glaucoma Awareness Program on Treatment Adherence
Assessing the Impact of a Structured Glaucoma Awareness Program on Treatment Adherence Among Glaucoma Patients at Tertiary Eye Hospital in Nepal
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Deekshya Malla
- Phone Number: +977 9851182007
- Email: deekshyamalla@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: - Adults aged ≥18 years
- Diagnosed with glaucoma
- Attending follow-up at the study hospital
- Able to provide informed consent
- Able to communicate in Nepali language
Exclusion Criteria:
Individuals with cognitive impairments; healthcare professionals; individuals who have participated in a formal glaucoma education program in the past year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glaucoma awareness
Glaucoma awareness educational package: Educational session, information leaflets, interactive discussions
|
Glaucoma awareness educational package: Educational session, information leaflets, interactive discussions. This study involves a behavioral/educational intervention only. No drugs, devices, or procedures are introduced as part of the study intervention. Participants continue their routine standard-of-care glaucoma treatment as prescribed by their treating ophthalmologist. No investigational drugs or devices are used as part of this study. Participants continue their usual prescribed anti-glaucoma medications as part of routine clinical care. The study intervention consists solely of a structured educational and awareness program. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment adherence scores
Time Frame: 10 months
|
Treatment adherence will be assessed using Glaucoma Treatment Compliance Assessment Tool- Short Form(GTCAT-S). Treatment adherence will be assessed using the Glaucoma Treatment Compliance Assessment Tool-Short Form (GTCAT-S), a validated self-administered questionnaire designed to evaluate adherence behavior, beliefs, and barriers among glaucoma patients. Approval for the use of GTCAT-S in this study has been obtained from the GTCAT development team. Scale Details:
Higher scores indicate better treatment adherence |
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participants' perceptions of the glaucoma awareness program assessed using semi-structured interview guide
Time Frame: 3 months post-intervention
|
Participants' perceptions of the glaucoma awareness program, including perceived usefulness, clarity of information, behavioral impact, barriers to treatment adherence, and suggestions for improvement, will be assessed through semi-structured in-depth interviews conducted at three months post-intervention. Assessment Method:
|
3 months post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Priya Adisesha Reddy, Seva Canada Society
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REMEH/ORCB/1/20251220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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