| CTRI Number |
CTRI/2025/07/090772 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“Living with Kidney Disease: Awareness, Struggles, and Barriers to Treatment. “ |
|
Scientific Title of Study
|
Knowledge, Determinants, and Barriers in the management of chronic kidney disease: A patient centered study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swaroop Shetty |
| Designation |
Medical Student |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Manipal, Department of Nephrology, First floor Kasturba Hospital Manipal,Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8450973803 |
| Fax |
|
| Email |
swaaaa13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivas Vinayak Shenoy |
| Designation |
Associate Professor in Nephrology KMC Manipal |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Nephrology KMC Manipal Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844374705 |
| Fax |
|
| Email |
shenoy.srinivas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas Vinayak Shenoy |
| Designation |
Associate Professor in Nephrology KMC Manipal |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Nephrology KMC Manipal Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844374705 |
| Fax |
|
| Email |
shenoy.srinivas@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal, Kasturba Medical College Manipal, Opp coin circle, Madhav Nagar, Manipal 576104, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Manipal Manipal 576104 |
| 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 |
| Dr Srinivas Shenoy |
Department of Nephrology, KMC Manipal |
Department of Nephrology, KMC Manipal, Manipal 576104
Udupi
KARNATAKA |
9844374705
Shenoy.srinivas@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-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (4) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Chronic Kidney Disease (CKD) at stage 3 and above on KDIGO guidelines of any etiology.
2. Adults aged 18 years and above |
|
| ExclusionCriteria |
| Details |
1. ESRD on dialysis. Patients already on long term dialysis will be excluded as their disease progression and management t may differ significantly.
2. Patients with Cognitive impairment or Severe Mental illness- Individuals with conditions that prevent them from understanding or responding accurately to awareness related assessments will be excluded
3. Patients with other serious co morbidities of other organs and those with terminal illnesses that may confound the study outcomes like severe heart failure, chronic liver disease, chronic pulmonary disease, chronic neurological conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Awareness of the HbA1c target (7%) and Knowledge about blood sugar control in preventing CKD progression and diabetes related complications.
2. Awareness of BP targets (130/80) per KDIGO and Hypertension as CKD risk factor; awareness of anti hypertensive drugs and lifestyle changes.
3. Awareness of safe analgesics use.
4. Awareness of diet control in CKD (salt, water intake etc).
5. Association between awareness and socioeconomic status. |
Points1 to 4: Baseline (during filling of questionnaire)
5. 6th Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship & disparities will be identified between awareness scores & socioeconomic class based on modified Kuppuswamy scale |
6th Month |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
01/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This prospective, observational cross-sectional study aims to assess the level of awareness about the importance of glycemic and blood pressure control, salt and fluid intake, knowledge about analgesic use, and barriers to accessing healthcare among patients with chronic kidney disease (CKD) Stage 3 and above. The study will include 384 adult patients attending nephrology outpatient clinics. Data will be collected through a structured questionnaire administered in English and Kannada. The goal is to identify gaps in health literacy and factors such as socioeconomic status, education, occupation, and access to care that may influence CKD management. Insights from this research will help guide educational interventions and policy planning to improve CKD outcomes. |