| CTRI Number |
CTRI/2020/07/026578 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
13/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effectiveness of modified mobile-health discharge instruction module on selected outcome variables among post-kidney transplant patients, PGIMER, Chandigarh, 2019-21 |
|
Scientific Title of Study
|
A quasi-experimental study to assess the effectiveness of modified m-health discharge instruction module on selected outcome variables among post-kidney transplant patients, PGIMER, Chandigarh, 2019-21 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal Sharma |
| Designation |
M.Sc. Nursing student |
| Affiliation |
National Institute Of Nursing Education PGIMER Chandigarh |
| Address |
National Institute Of Nursing Education PGIMER Chandigarh
Room no-81, Working women hostel, sector-12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8559082940 |
| Fax |
|
| Email |
komusharma383@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Dutta |
| Designation |
Lecturer |
| Affiliation |
National Institute Of Nursing Education PGIMER Chandigarh |
| Address |
National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Dutta |
| Designation |
Lecturer |
| Affiliation |
National Institute Of Nursing Education PGIMER Chandigarh |
| Address |
National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Nursing Education, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
National Institute Of Nursing Education |
| Address |
PGIMER, Chandigarh |
| 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 |
| Komal Sharma |
Renal Transplant Surgery Unit |
Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH |
8559082940
komusharma383@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified m-health Discharge Instruction Module |
This will be conducted in 3 steps. firstly i will screen the patients who are already part of existing m-health discharge checklist and then i will collect the data and modify the m-health discharge checklist and at last i will see the effectiveness of modified m-health discharge instruction module among them. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Post-kidney transplant patients only |
|
| ExclusionCriteria |
| Details |
Patient suffering with complications of kidney transplant |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Immunosuppression medication adherence
Diet
Wound care
Lab investigations
Follow up
Weight monitoring
Fluid intake
Output
Blood glucose monitoring
Symptom management
Prevention of infection
Use of helpline number
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will help the post-kidney transplant patient for the reduction of risk of graft rejection and will be having quality of life |
1 year |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 1 |
|
Date of First Enrollment (India)
|
16/07/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
in this study researcher will implement the modified m-health discharge instruction module which will ultimately help in future for post kidney transplant patients in their health and will reduce the risk of graft rejection. and provide them quality of life , the aim of this study is to provide quality of life so that they can enjoy their life as a healthy person instead of transplant person. |