| CTRI Number |
CTRI/2025/10/096038 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Telemedicine, Self care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Telemedicine to Improve Self-Care Among People with Chronic Kidney Disease |
|
Scientific Title of Study
|
The Impact of Telemedicine in Enhancing Patient Self Care for Management of Chronic Kidney Diseases |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santosh Pokhrel |
| Designation |
Junior Resident |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Room No. 8, Department of Internal Medicine, Division of Medicine, B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan,Sunsari, Koshi Province, Nepal
56700
Other |
| Phone |
9779846577535 |
| Fax |
|
| Email |
npsantosh13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Kumar Sharma |
| Designation |
Rector and Professor |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Room No. 8, Department of Internal Medicine, Division of Medicine, B.P. Koirala Institute of Health Sciences(BPKIHS),Dharan,Sunsari, Koshi Province, Nepal
56700
Other |
| Phone |
9779852047228 |
| Fax |
|
| Email |
sanjibks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Pokhrel |
| Designation |
Junior Resident |
| Affiliation |
BP Koirala Institute of Health Sciences |
| Address |
Room No. 8, Department of Internal Medicine, Division of Medicine, B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan,Sunsari, Koshi Province, Nepal
56700
Other |
| Phone |
9779846577535 |
| Fax |
|
| Email |
npsantosh13@gmail.com |
|
|
Source of Monetary or Material Support
|
| BP Koirala Institute of Health Science(BPKIHS),Dharan, Sunsari,Koshi Province, Nepal |
|
|
Primary Sponsor
|
| Name |
BP Koirala Institute of Health Science |
| Address |
Dharan,Nepal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof DrSanjib Kumar Sharma |
BP Koirala Institute of Health Sciences |
Department of Internal Medicine, Division of Medicine,Room no 8 .
|
9779852047228
sanjibks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review committee, BPKIHS Dharan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Usual Care |
Participants in the control arm will receive routine standard care for 6 months , including in-person consultations and management as per current nephrology or internal medicine follow-up protocol, without structured telemedicine-based self-management support |
| Intervention |
Telemedicine |
Besides routine standard care, patient in this arm which receive Behavioral/Educational (Non-Pharmacologic)intervention.
This intervention consists of a structured telemedicine-based self-care support program for 6 months for patients with chronic kidney disease (CKD). It is designed to improve self-management behaviors, treatment adherence, and health outcomes through remote education, monitoring, and support.
videos and materials on CKD management, lifestyle modification, dietary control, and medication adherence.
Patients are encouraged to regularly monitor blood pressure, fluid intake/output, and weight at home, and record them in a paper.
SMS reminders for medication adherence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed as Chronic Kidney Diseases as per KDIGO criteria
Patient willing to give consent and able to communicate verbally
|
|
| ExclusionCriteria |
| Details |
Under dialysis (Hemodialysis and peritoneal dialysis)
Patient who do not have mobile phone and internet acces
Unwillingness to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Composite of Dialysis, death and hospitalization
Change in eGFR |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of blood pressure, HbA1c and Hb
Adherence to medication
|
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2025 |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
Modification(s)
|
Chronic Kidney Disease (CKD) is a significant public health issue associated with increased morbidity and progression to end-stage renal disease. Although treatment options are available, outcomes remain suboptimal due to limited disease awareness, inadequate self-care practices, and poor adherence to follow-up. Telemedicine has emerged as a promising approach to enhance patient education, engagement, and self-management, particularly in resource-limited settings. This randomized controlled trial is designed to assess the impact of a structured telemedicine-based self-management support program on the progression and morbidity of CKD. The study will be conducted at a tertiary care center in Nepal. A total of 108 eligible CKD patients will be randomly allocated into two groups: an intervention group receiving telemedicine-based education and follow-up, and a control group receiving standard care. Primary outcomes include changes in estimated glomerular filtration rate (eGFR), hospitalization events, dialysis initiation, and adherence to follow-up over a period of 6 months. Secondary outcomes include medication adherence, blood pressure control, and relevant laboratory parameters. The study aims to evaluate the effectiveness of telemedicine in enhancing patient-centered care and improving outcomes in CKD management
|