| CTRI Number |
CTRI/2024/02/063212 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MOBILE APPLICATION BASED TOOL FOR COMPLIANCE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparision of routine daily medicine intake vs mobile app based medicine intake to improve the adherence of advise given by the doctor |
|
Scientific Title of Study
|
Patient supported care model: Pilot study of a mobile application based tool to increase compliance in patients with chronic kidney disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanja Sameer Behera |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate institute of Medical Education and Research, Chandigarh |
| Address |
Department of Nephrology
PGIMER
CHANDIGARH
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9168940405 |
| Fax |
|
| Email |
sanjasameer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek Kumar |
| Designation |
Associate Proffessor |
| Affiliation |
Post Graduate institute of Medical Education and Research, Chandigarh |
| Address |
Department of Nephrology
PGIMER
CHANDIGARH
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087429731 |
| Fax |
|
| Email |
enigma165@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanja sameer Behera |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate institute of Medical Education and Research, Chandigarh |
| Address |
Department of Nephrology
PGIMER
CHANDIGARH
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9168940405 |
| Fax |
|
| Email |
sanjasameer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Sanja Sameer Behera |
| Address |
senior resident, Department of Nephrology, PGIMER, Chandigarh, 160012 |
| Type of Sponsor |
Other [self] |
|
|
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 Sanja Sameer Behera |
PGIMER, Chandigarh |
Room number-7,Department of Nephrology,C-Block, PGIMER,Chandigarh
Chandigarh
CHANDIGARH |
9168940405
sanjasameer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethical Committee |
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 |
| Intervention |
Mobile Application based tool |
Patients in intervention arm will be invited to install the mobile application on their smartphones and then, trained on how to use it. They will also be provided with instructional video for the same. The workflow will be as follows:
Doctor prescribes drugs to the patient.
The prescription slip is captured either electronically or as a photograph in application.
The patient/hospital staff enters the actually delivered/procured drugs in application (note is made of drug name/dosage/administration schedule/quantity bought or delivered or procured for each drug).
The patient now receives daily reminders as per previously captured schedule.
A pop-up requests confirmation as to whether he has taken drugs or not within last 24 hours. If not, he selects which ones he has not taken. He can record the reason as text or voice message. There will also be a provision for patients to record any issues (related to mobile application or health status) that they might face through text or voice. In case of any emergency, they may contact the investigators through telephone or visit the hospital. Records of the same will be maintained by the investigators.
Lack of input in the mobile application by patient for 24 hours will be taken as ‘missed one day of usage’.
The patient gets reminder one week prior to estimated date of complete utilization of drug (based on data captured above).
Patient goes back to doctor and the revised prescription is again captured as above.
Information that will be captured through mobile application:
1. Prescription (type, dose, frequency, quantity)
2. Drugs taken (type, dose, frequency, quantity)
3. Compliance with prescription (number of times doses are missed)
4. Reasons for non-compliance
5. Any miscellaneous issues recorded by patient.
They will also be instructed to bring prescription refill documents or bills mentioning the drugs and their delivered quantities and prices along with empty boxes/strips at the end of 3 months. |
| Comparator Agent |
Routine care |
Patients in control arm will continue to receive care as they were receiving before. They will be instructed to bring prescription refill documents or bills mentioning the drugs and their delivered quantities and prices along with empty boxes/strips at the end of 3 months. They will also be encouraged to report causes for non-compliance with prescribed treatment, if any. All clinically significant events during the study period will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients with CKD stage G3-4 (defined as per KDIGO CKD guidelines) who will be attending the outpatient clinic in the Department of Nephrology at PGIMER with Clinically stable status for last 3 months as judged by treating physician and having Access to a smartphone that can run the mobile application
|
|
| ExclusionCriteria |
| Details |
All patients with CKD stage G3-4 (defined as per KDIGO CKD guidelines) who will be attending the outpatient clinic in the Department of Nephrology at PGIMER with
1. Poor functional status as judged by treating physician
2. Present or past diagnosis of malignancy
3. Pregnancy or lactation in case of females
4. Organ transplant recipient
5. Previous diagnosis of any psychiatric illness or illicit drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
1. Difference in compliance (C) with prescribed treatment between groups
|
03 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reasons for non-compliance in the study population
2. Proportion of patients who do not use mobile application for ≥15 days over 3 months in the intervention group and reasons for the same
|
03 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="1"
Months="0"
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
|
A number of mobile applications are available which primarily serve to remind the patient about his prescribed medications. However, none of these is designed to ascertain the causes of non-compliance. We plan to use the basic workflow of such mobile applications and design a new mobile application with following features: 1. Both the treating physician or supporting healthcare staff and patient will be users of the system. 2. Patients will be able to enter the details of procured/bought/received medications in the application. These details will include name, dose and frequency. They will also note duration (in days) of the prescribed treatment. 3. Physicians will be able to track the details of compliance and reasons for non-compliance, if recorded by the patient. |