| CTRI Number |
CTRI/2025/09/094987 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of treatment adherence and its determinants among the patients with end-stage renal disease undergoing dialysis in a tertiary care centre |
|
Scientific Title of Study
|
Assessment of treatment adherence and its determinants among the patients with end-stage renal disease undergoing dialysis in a tertiary care centre – A cross-sectional analytical 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 |
Arnab Pati |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
College of Nursing, JIPMER |
| Address |
Room Number 105, College of Nursing,JIPMER, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8670765961 |
| Fax |
|
| Email |
122477C09@jipmer.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Ramamoorthy |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, JIPMER |
| Address |
Room Number 1, 2nd Floor, College of Nursing, JIPMER,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9842399340 |
| Fax |
|
| Email |
laxmi_ramamoorthy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Ramamoorthy |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, JIPMER |
| Address |
Room Number 1, 2nd Floor, College of Nursing, JIPMER,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9842399340 |
| Fax |
|
| Email |
laxmi_ramamoorthy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry – 605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Dhanvantari Nagar, Gorimedu, Puducherry – 605006, India |
| Type of Sponsor |
Government medical college |
|
|
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 Lakshmi Ramamoorthy |
JIPMER Outpatient Hemodialysis Centre (JOPHDC) |
Room No 1, JIPMER Outpatient Hemodialysis Centre (JOPHDC),JIPMER, Dhanvantari Nagar, Gorimedu, Puducherry – 605006, India
Pondicherry
PONDICHERRY |
9842399340
laxmi_ramamoorthy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Nursing Courses (Human Studies), JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with End Stage Renal Disease (ESRD) undergoing maintenance hemodialysis for at least 3 months.
Patients aged 18 years and above. |
|
| ExclusionCriteria |
| Details |
Patients with communication difficulties. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment adherence score among patients with end-stage renal disease undergoing maintenance hemodialysis |
Single assessment during dialysis session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determinants of treatment adherence |
Single assessment during dialysis session. |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "98"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2025 |
| Date of Study Completion (India) |
19/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The results will be submitted for publication after completion of data analysis. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
End stage renal disease or kidney failure is a serious and rapidly growing condition of health. India has a large number of patients who require dialysis. The failure of patients to adhere strictly to the complex care plan dialysis, medication, fluid and dietary restraint can lead to severe complications, prolonged hospitalization and even demise. This cross sectional study examines the level of adherence to treatment regimen of ESRD patients under dialysis treatment in a teriary care centre. It also looks into the socio demographic, clinical influences on adherence. The results need to provide information to health workers in the design and implementation of effective education and counseling programs that would accomplish better patient results and quality of life.Participant recruitment and data collection for this observational study have been completed as per the approved protocol. The study is currently in the data analysis phase. |