| CTRI Number |
CTRI/2018/06/014633 [Registered on: 28/06/2018] Trial Registered Prospectively |
| Last Modified On: |
21/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Self management guidelines for post renal transplant recipient ] |
| Study Design |
Other |
|
Public Title of Study
|
A study to check effectiveness of self management guidelines for patients undergoing renal transplant surgery. |
|
Scientific Title of Study
|
A Quasi experimental study to evaluate the effectiveness of "self management guidelines" on selected variables among renal transplant recipient at Renal Transplant Surgery Units, PGIMER, Chandigarh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha Thakur |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Sector 12, Chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9812716518 |
| Fax |
|
| Email |
thakurpratibha96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Shruti |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Sector 12, Chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
shruti2011pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratibha Thakur |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Sector 12, Chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9812716518 |
| Fax |
|
| Email |
thakurpratibha96@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education. |
|
|
Primary Sponsor
|
| Name |
Pratibha Thakur |
| Address |
National Institute of Nursing Education, PGIMER Sector 12, 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 |
| PRATIBHA THAKUR |
NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
Department of Renal Transplant Surgery/ Transplant ICU/ First floor floor
Chandigarh
CHANDIGARH |
9812716518
thakurpratibha96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, Patients under going renal transplant , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patient of renal transplant getting routine care in hospital. |
Experimental group will be given self management guidelines and Control group will be given routine care. |
| Intervention |
Self management guidelines |
Self management guidelines for patients undergoing renal transplant.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age group undergoing kidney transplant.
Patients who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
Patient diagnosed with mental illness.
Patient below 18 year of age group.
Patient diagnosed with mental illness.
Patients who are not willing to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sign and symptoms of rejection.
Prevalence of infection.
Therapeutic compliance.
|
2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/07/2018 |
| Date of Study Completion (India) |
04/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/12/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Article is accepted for publication under International journal of Scientific Research |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Renal transplant is the best treatment of choice for end stage renal disease but also leads to changes in life roles in most areas of kidney transplant recipients lives. Goal of the current study was to evaluate the effectiveness of “self management guidelines†on therapeutic compliance , anxiety and knowledge in renal transplant recipient. A quasi-experimental design was used in the study. Total 60 samples were taken (30 in each control and experimental group) by total enumeration sampling. Self management guide lines were developed and taught to the experimental group and only routine care was given to the control group. Interview schedule and observation method was used for assessment of outcome variables. Results showed that experiment group exhibit good adherence with therapeutic compliance checklist where as in control group average adherence was seen. Median anxiety score was found highly significant in experiment group as compared to control group (p value <0.001). There was increase in postoperative knowledge among experimental group. In the present study self-management guidelines for renal transplant recipient were found to be effective in terms of increasing post transplant therapeutic compliance decreased anxiety and increased knowledge |