| CTRI Number |
CTRI/2022/02/040432 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on National Program for Control of Blindness and Visual Impairment (NPBCVI) in Navi Mumbai, Maharashtra. |
|
Scientific Title of Study
|
A study on evaluation of National Program for Control of Blindness and Visual
Impairment (NPCBVI) in Navi Mumbai, Maharashtra. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trupti Phulmali |
| Designation |
BDS, Postgraduate student (MPH) |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no-61, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8108465347 |
| Fax |
|
| Email |
trupti.phulmali@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Assistant Professor (BDS, MPH, PhD (Pursuing)) |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no-53, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Assistant Professor (BDS, MPH, PhD (Pursuing)) |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no-53, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.com |
|
|
Source of Monetary or Material Support
|
| Navi Mumbai Municipal Corporation. 61. Sakal Bhavan Road, Sector 11, CBD Belapur, Navi Mumbai, Maharashtra, 400614. |
|
|
Primary Sponsor
|
| Name |
Dr Trupti Phulmali |
| Address |
Department of Health Policy, PSPH, Manipal Academy of Higher Education, Manipal, Karnataka, 576104. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr H Singh |
Navi Mumbai Municipal Corporation Hospital |
Room no- 5, Ophthalmology Department, Ophthalmology division, Mary Church, Juhu Nagar, Sector 10A, Vashi, Navi Mumbai, Maharashtra, 400703
Thane
MAHARASHTRA |
9322590632
drhsingh2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| Navi Mumbai Municipal Corporation Health Division |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for stakeholders-
A- All the stakeholders who are involved in the
implementation of the NPCBVI program in Navi Mumbai.
B- Inclusion Criteria for beneficiaries- Patients 50 years and above.
a- Patient who has undergone Cataract surgery or will be going cataract surgery.
b- Patient 40 and above who has undergone some eye surgeries or will be going for the
same |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of study will be used to see the functioning of the National Program at the local level and assessing of the facilities providing for the Program. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The findings of the study will help the stakeholders and National Health Program to
address the challenges in the program and faced by the beneficiaries more efficiently.
Furthermore, it will add to the knowledge of scientific and the general community about the
program and how it can benefit more larger population and generate evidence. |
5 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2022 |
| Date of Study Completion (India) |
25/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the increasing population, there is also an increase in the share percentage of elderly people in India. There was an increase in the aging population of nearly 34
million elderly persons in 2021 over the census 2011 and it is expected to increase
further around 56 million by 2031. Along with the aging population and extended life
expectancy, the number of people with cataracts is expected to increase
continuously. Cataracts are still is the principal cause of blindness, severe visual
impairment, and moderate visual impairment.
Maharashtra belongs to one of the five states where there is the highest number of
disabled people in India. Visual disability is still the most prevalent in the elderly
population. According to the survey conducted by NPBCVI in India, Maharashtra
state, district Thane (2.06%) and Wardha (2.02%) reported a higher prevalence of
blindness than the national average (1.9%), and visual impairment was seen lower in
the population 50 years and above than the national average (13.76%). There are
still many barriers faced by the elderly population in accessing cataract surgical
services like local reasons, financial constraints, and need for surgery not felt. The aim of the study is To evaluate the implementation status of the National Program for Control of
Blindness and Visual Impairment (NPCBVI) in Navi Mumbai. The first objective of the study is to assess the existing public health facilities for NPCBVI in Navi Mumbai and the second objective of the study is to understand the implementation of program from the perspective of stakeholders and
beneficiaries. To achieve my 1st objective, I will be
visiting the Navi Mumbai Municipal Corporation facility with an observation checklist to assess the facilities in relation to the
NPCBVI program. To achieve my 2nd objective, I will take interviews the stakeholders and
beneficiaries who are involved in this program by making an in-depth interview guide with an open-ended questionnaire. The responses will be audio recorded by taking informed consent
of the stakeholders and beneficiaries and confidentiality will be maintained of the data. The
data transcripts will be used to conduct thematic analysis. The analyzed data through
interviews will be used to understand the implementation of the NPCBVI program in Navi
Mumbai.
The stakeholders that will be involved are Medical Superintendent, Doctors
(Ophthalmologists), Resident doctors, Staff nurses, and Public Health Nurse. In the given
hospital weekly around 200-300 OPDs are done, out of which I would randomly select 5
beneficiaries a week according to the inclusion criteria for in-depth interviews. The ratio of
stakeholders to beneficiaries I will be taking would be 1:2. Therefore, this study is to understand the implementation of the NPCBVI program in
Navi Mumbai, Thane district and get a perspective of the stakeholders of the program
to address the challenges faced during implementation, to provide necessary
suggestions and recommendations to bring effective service provision. Additionally,
this study also takes the point of view of the beneficiaries who form an integral part of
the program. Furthermore, learn about the experiences, gain some opinions and their
views which will help to understand the implementation of the program. |