| CTRI Number |
CTRI/2021/08/035706 [Registered on: 16/08/2021] Trial Registered Prospectively |
| Last Modified On: |
03/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effectiveness of ‘Nurse Led Intervention’ on treatment adherence and quality of life among patients having Glaucoma. |
|
Scientific Title of Study
|
An Interventional Study to assess the effectiveness of a Nurse Led Intervention on adherence of treatment and quality of life among patients having Glaucoma attending Glaucoma Clinic, AEC, PGIMER, Chandigarh, 2020-22 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjan |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
Room number,211, National Institute of Nursing Education
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8586013774 |
| Fax |
|
| Email |
gunnukandpal15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjula Thakur |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
Room number,122, National Institute of Nursing Education
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855487722 |
| Fax |
|
| Email |
manjula2676@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunjan |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
Room number,211, National Institute of Nursing Education
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8586013774 |
| Fax |
|
| Email |
gunnukandpal15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NINE |
| Address |
PGIMER, Chandigarh |
| 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 |
| Gunjan |
PGIMER |
Room no.306, 2nd Floor, Glaucoma Clinic, AEC, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8586013774
gunnukandpal15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse- Led Intervention includes
a)Counselling session
b)Demonstration and return demonstration |
Nurse- Led Intervention includes
a)Counselling session
b)Demonstration and return demonstration
Intervention will continue for 2 months including demonstration, return demonstration and regular follow-up.
Follow-up will be done after 1 week then after 2 weeks and then after 1 month.
|
| Comparator Agent |
Routine treatment |
Routine treatment as prescribed by physician and will be assessed for treatment adherence and quality of life. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate
2. Able to understand Hindi, English or Punjabi
|
|
| ExclusionCriteria |
| Details |
1. Patients having psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To develop and implement protocol of a ‘Nurse- led Intervention’ Programme on adherence of treatment among patients having Glaucoma attending Glaucoma clinic, AEC, PGIMER, Chandigarh
|
primary outcomes will be assessed at starting wile collecting baseline data and after 10 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To assess the effectiveness of a ‘Nurse- led Intervention’ programme on adherence of treatment and quality of life among patients having Glaucoma attending Glaucoma clinic, AEC, PGIMER, Chandigarh |
primary outcomes will be assessed at starting wile collecting baseline data and after 10 weeks. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/08/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Glaucoma is a chronic, progressive and most often asymptomatic disease.
It is the second most leading cause of irreversible blindness worldwide as per
World Health Organisation. It is the leading cause of preventable blindness. Glaucoma
is often called the ‘silent thief of sight’ as patients do not experience the
symptoms until it reaches the late stage. In India, Glaucoma is the leading
cause of treatable non reversible blindness [1]. An estimated 60.5 million
people suffered from Glaucoma in 2010 and by 2020 this will reach 79.6 million. Prevalence of Glaucoma is increasing at a rapid
speed so it is very important to keep a check on it so as to avoid blindness in
later stage as its one of the major complication. To avoid this further
deterioration and complication in disease condition, Medication Adherence and
regular follow-up plays an important role. Due to lack of time and busy schedule and
inadequate knowledge, the routine medication management and regular follow- up required for
Glaucoma is fully underestimated which leads to poor prognosis and onset of
irreversible complications. It is noticed that due to one or more above
reasons most of the people does not follow the proper medication schedule as
well as does not show up for routine follow-up. Due to easy availability and direct contact with
patient at all health care delivery system, nurses are the HCP which are
thought to fit in place for educating and promoting awareness among people regarding
Glaucoma through various Nurse-led Interventions. Therefore, Nurse Led Intervention and
proper communication will lead to increase in medication- adherence among
patients diagnosed with Glaucoma. Further increase in medication adherence,
also improves the Quality of Life of these people. This study will also help us to state
the need and benefits of monitoring Intra-Ocular Pressure, its complications
and correct way of eye drop installation as well as digital IOP
self-monitoring. Keeping all the above factors in mind present study is planned
to access the effectiveness of Nurse-Led Intervention Programme for patients
diagnosed with Glaucoma. RESEARCH
STATEMENT: A
Randomized Control Trial to assess the effectiveness of a ‘Nurse Led
Intervention’ on adherence of treatment and quality of life among patients
having Glaucoma attending Glaucoma clinic, AEC, PGIMER, Chandigarh, 2020-22 OBJECTIVES: •
To develop and implement protocol
of a ‘Nurse- led Intervention’ Programme on adherence of treatment among
patients having Glaucoma attending
Glaucoma clinic, AEC, PGIMER, Chandigarh •
To assess the effectiveness of a
‘Nurse- led Intervention’ Programme on adherence of treatment and quality of
life among patients having Glaucoma attending Glaucoma clinic, AEC, PGIMER,
ChandigarhNULL
HYPOTHESES (Ho): There
will be no significant effect of Nurse- Led Intervention on treatment adherence
among patients having Glaucoma at 0.05 level of significance. There
will be no significant effect of Nurse- Led Intervention on Quality of life
among patients having Glaucoma at 0.05 level of significance. There
will be no significant effect of Nurse- Led Intervention on Prevention of
complication among patients having Glaucoma at 0.05 level of significance. ALTERNATE
HYPOTHESES (H1): There
will be significant effect of Nurse- Led Intervention on improving treatment
adherence among patients having Glaucoma at 0.05 level of significance. There
will be significant effect of Nurse- Led Intervention on improving Quality of
life among patients having Glaucoma at 0.05 level of significance. There
will be significant effect of Nurse- Led Intervention on enhancing Complication
prevention among patients having Glaucoma at 0.05 level of significance.
Quantitative approach will be used to conduct this study using Experimental two Group Pre-test Post-test research design on Glaucoma patients of sample size 200. Interventional protocol includes the Nurse-led intervention Programme details which will be conducted
during the study in the Interventional phase. It will contain all the
information regarding Glaucoma which will be given to patients and planning of
how these procedures will be conducted. Protocol will be prepared in the form
of booklet ‘Know about Glaucoma’ and flash book. 1)
BOOKLET and FLASH BOOK ‘KNOW ABOUT GLAUCOMA’: This
booklet and flash book will be developed by the researcher which will serve as
ready reference for the subjects. It will include detailed information regarding Glaucoma, its causes,
risk factors, sign and symptoms associated with Glaucoma, its management,
importance and its advantages of treatment adherence and preventive causes
which should be taken to reduce the risk factors of further deterioration in
disease condition. It will also contain protocol to perform different eye exercises, IOP
monitoring and Eye drop instillation which will be practiced by the patients
daily as these exercises will help in maintain the Intra-Ocular Pressure.
2)
DIARY MAINTAINENCE: Patient
will be asked to maintain a daily dairy to note down the timings when they are
taking medications and how many times they forget to take medications. They
will also be asked to note how many times they are doing exercises in a day and
how many times they are checking their IOP in a week. This dairy will be used for data analysis on
follow-up regarding medication adherence and performing eye exercises on daily
basis.
|