| CTRI Number |
CTRI/2024/05/066925 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association between depression and adherence to treatment in glaucoma |
|
Scientific Title of Study
|
Depression, coping, quality of life and adherence to treatment in glaucoma |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neetha KIR |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Ophthalmology,
Kasturba Medical College Manipal,
Manipal
Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9886161979 |
| Fax |
|
| Email |
neetha.kir@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Neetha KIR |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Ophthalmology,
Kasturba Medical College Manipal,
Manipal
Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9886161979 |
| Fax |
|
| Email |
neetha.kir@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Neetha KIR |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Ophthalmology,
Kasturba Medical College Manipal,
Manipal
Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9886161979 |
| Fax |
|
| Email |
neetha.kir@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital Manipal |
|
|
Primary Sponsor
|
| Name |
Neetha KIR |
| Address |
Department of Ophthalmology, Kasturba Medical College Manipal, Manipal, Udupi, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Suma T Udupa |
Department of Psychiatry, Kasturba Medical College Manipal, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetha KIR |
Kasturba Medical College and Hospital, Manipal, Manipal |
Department of Ophthalmology, Room No 25, 2nd floor, Old OPD Block, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA |
9886161979
neetha.kir@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H40||Glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Established diagnosis of glaucoma, both open angle and angle closure glaucoma, both primary and secondary glaucoma |
|
| ExclusionCriteria |
| Details |
Pediatric glaucoma cases who are now adults
Patients who do not consent to be part of the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relationship between depression in glaucoma and adherence to treatment |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| coping mechanisms used by the participants to handle glaucoma. |
At baseline |
| Quality of life in glaucoma patients |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
16/05/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rationale/ gaps in existing knowledge: Glaucoma is the leading cause of irreversible blindness in the world and poor compliance/ adherence is a problem in its management. Glaucoma is associated with higher levels of depression and this can be a cause for lower levels of adherence to treatment in glaucoma patients. There are two studies evaluating depression in Indian glaucoma patients. There are no studies evaluating the influence of depression on adherence to treatment in Indian glaucoma patients. Novelty: This would be one of the first studies assessing depression among glaucoma patients and its association with adherence to glaucoma treatment among Indian patients. Objectives: To assess, a. the relationship between depression and adherence to glaucoma treatment, b. coping mechanisms to glaucoma and quality of life among glaucoma patients, Methods: Patients with established diagnosis of glaucoma visiting glaucoma clinic at a tertiary hospital will be administered four questionnaires after obtaining consent. The questionnaires are- The Depression, Anxiety and Stress Scale - 21 Items (DASS-21), Coping Orientation to Problems Experienced Inventory (Brief-COPE), National Eye Institute-Visual Function Questionnaire (NEIVFQ-25), Glaucoma Treatment Compliance Assessment Tool(GTCAT). These will quantify depression, coping orientations, quality of life and compliance to glaucoma treatment. Association between depression in glaucoma and compliance/ adherence will be evaluated using correlation studies. Expected outcome: Quantification of depression among glaucoma patients and its association with adherence to treatment. |