| CTRI Number |
CTRI/2023/03/051165 [Registered on: 29/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalence of Chronic Kidney Disease and Evaluation of the effectiveness of multimodal intervention on knowledge, lifestyle modification on Chronic Kidney Disease among adults in a rural community |
|
Scientific Title of Study
|
A study on prevalence of Chronic Kidney Disease and Evaluation of the effectiveness of multimodal intervention on knowledge, lifestyle modification on Chronic Kidney Disease among adults in a rural community of Udupi District, Karnataka state – A pretest- posttest intervention study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Leena Sequira |
| Designation |
Assistant Professor. sr scale and Principal, Manipal school of nursing |
| Affiliation |
Manipal College Of Nursing, Manipal Academy of Higher Education |
| Address |
5th floor, Manipal School of nursing. Room no. 502.
Manipal Academy of Higher Education
Madhav Nagar.
Udupi Taluk. Karnataka
Manipal. 576104
5th floor, Manipal School of nursing. Room no. 502.
Manipal Academy of Higher Education
Madhav Nagar.
Udupi Taluk. Karnataka
Manipal. 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9481971214 |
| Fax |
|
| Email |
leena.sequ@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Leena Sequira |
| Designation |
Assistant Professor. sr scale and Principal, Manipal school of nursing |
| Affiliation |
Manipal College Of Nursing, Manipal Academy of Higher Education |
| Address |
5th floor, Manipal School of nursing. Room no. 502.
Manipal Academy of Higher Education
Madhav Nagar.
Udupi Taluk. Karnataka
Manipal. 576104
5th floor, Manipal School of nursing. Room no. 502.
Manipal Academy of Higher Education
Madhav Nagar.
Udupi Taluk. Karnataka
Manipal. 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9481971214 |
| Fax |
|
| Email |
leena.sequ@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Leena Sequira |
| Designation |
Principal |
| Affiliation |
Manipal College Of Nursing |
| Address |
5th floor, Manipal School of nursing. Room no. 502.
Manipal Academy of Higher Education
Madhav Nagar.
Udupi Taluk. Karnataka
Manipal. 576104
5th floor, Manipal School of nursing. Room no. 502.
Manipal Academy of Higher Education
Madhav Nagar.
Udupi Taluk. Karnataka
Manipal. 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9481971214 |
| Fax |
|
| Email |
leena.sequ@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian council of Medical research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Department of health research, Ministry of health and family welfare, Government of India. |
| Type of Sponsor |
Government funding agency |
|
|
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 Leena Sequira |
Manipal College of nursing, Manipal Academy of Higher Education |
Assistant professor Sr. Scale and Principal Manipal School of nursing. Room No. 502.
Udupi
KARNATAKA |
919481971214
leena.sequ@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human volunteers who are available during the data collection period |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal Intervention |
Multimodal Intervention refers to educating the participants about CKD and life style modification and follow up every fourth month till one year and assessment of random blood sugar and blood pressure. |
| Comparator Agent |
Not applicable. Single arm study |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Phase1- People aged more than 19 years, available during the data collection period and willing to participate in the study.
Phase II -The participants identified with stage 3 and above during the phase I. |
|
| ExclusionCriteria |
| Details |
Phase I -Critically ill patients and cognitively impaired, patients undergoing dialysis.
PhaseII- CKD patients undergoing dialysis, Critically ill patients and cognitively impaired. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ï‚·Reduction in progression of CKD
ï‚·Improvement in knowledge
ï‚·Lifestyle modification
ï‚·Health seeking behavior
ï‚·Reduction of health cost
ï‚·Improvement in quality of life |
baseline to one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lifestyle modification
ï‚·Health seeking behavior
ï‚·Reduction of health cost
ï‚·Improvement in quality of life |
Baseline to one year |
|
|
Target Sample Size
|
Total Sample Size="1100"
Sample Size from India="1100"
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)
|
01/04/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aims & objectives: · To find the prevalence of CKD among people aged more than 19-60 years and to find the effectiveness of multimodal intervention on knowledge, lifestyle modification. |