Amblyopia Clinical Trial
Official title:
Effect of Counseling and Reminders in Improving the Follow-up Rate of Pediatric Patients (0-16 Years) at Bharatpur Eye Hospital, Nepal: an Intervention Study
Verified date | March 2022 |
Source | Seva Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Follow-up of pediatric patients is important for their regular ocular morbidity monitoring, especially for amblyopia management. An observatory data of 1st week (1st to 7th) of January 2019 revealed that the follow-up compliance was very low (22%) among children aged 0-16 years in the pediatric department of Bharatpur Eye Hospital. A problem tree analysis showed a lack of awareness in children and their parents regarding the importance of follow-up and patients forgetting regarding the follow-up visit, usually when there is the long duration of follow up are the major contributing factors for poor adherence to follow-up. So, an intervention study was aimed at finding the effectiveness of counseling and reminders through SMS and phone calls to improve the follow-ups. All pediatric patients 0-16 years of age with ocular conditions requiring at least 3 follow-ups in the study period (January 2021 to April 2021) will be included. Two hundred and sixty-four participants will be equally distributed to three groups: routine standard care, counseling, and reminders with SMS and phone calls. In the routine care group, children will undergo routine care as per existing practice in the hospital and there will be no additional intervention. In counseling group, in addition to routine care parents/guardians along with the child will receive counseling from a trained counselor as per the set counseling protocol in every follow-up visits and will also be provided with the disease-specific information leaflets as additional information material before the child is discharged from the department. In the SMS and phone call reminder group, in addition to routine care, parents/guardians of children will receive reminders through short messaging text (SMS) 3 days and phone calls one day prior to the scheduled visit. Compliance to follow up Participants completing all the three follow-up visits as per the schedule within the window period of +/-2 days will be considered as a complaint to follow up. However, the follow-ups of all the participants will be recorded although that is beyond the window period. The primary outcome will be measured by the proportion of children completing all three scheduled follow-ups. The ethical approval has been obtained from the Institutional Review Committee of NHRC (ERB protocol registration number 761/2020 P). Informed consent will be taken from parent and child. Conclusion: If interventions improve the follow-up rate and are cost-effective, this can be applied in all the departments of the hospital.
Status | Completed |
Enrollment | 264 |
Est. completion date | December 30, 2021 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility | Inclusion Criteria: - all pediatric patients 0-16 years age advised for at least 3 follow up visits within 4 months period (January 2021 to April 2021) at Bharatpur Eye Hospital - Patients who require weekly, bi-weekly (fortnight), or monthly follow up visits, - In certain conditions, some severe cases require earlier follow up than the scheduled follow up schedule, those cases will be included, - Parents/guardians of children who own a mobile phone or have daily access to a phone and are able to use the SMS (Short Message Sending) feature on these phones, - Parents of children willing to enroll their children in the study Exclusion Criteria: - Children who require less than 3 follow up visits, - Ocular conditions requiring daily follow up visits will be excluded because it is not feasible to send the reminder phone call and SMS for daily follow up - Children who have already been treated and under regular follow up, - Children with ocular conditions requiring to follow up beyond four months, - Children whose follow up schedules fall beyond the study duration, - Parents/ guardians of the children not willing to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Nepal | Bharatpur Eye Hospital | Bharatpur | Chitwan |
Lead Sponsor | Collaborator |
---|---|
Seva Foundation | Bharatpur Eye Hospital, Indian Institute of Public Health, India, Queen's University, Belfast, Seva Canada Society |
Nepal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children completing all three follow up visits | The primary outcome is the proportion of children completing all three follow up visits in routine standard care group, counseling group and reminders through SMS and phone call group. | 4 months | |
Secondary | Factors affecting compliance to follow-up | effect of parental/guardian education status in compliance to follow-up,
visual status of the children in subsequent follow-up visit, c)effect of travelling distance and cost in compliance to follow-up. |
2 months | |
Secondary | Cost-effectiveness of the intervention | 1 month |
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