| CTRI Number |
CTRI/2024/04/065011 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [PATIENTS] |
| Study Design |
Other |
|
Public Title of Study
|
Provide effective nursing care for prevention and management of stroke and heart disease among hypertensive patients |
|
Scientific Title of Study
|
“A study to assess the effect of Comprehensive Nursing Care Module on prevention and
management of selected vascular complications among Hypertensive patients in a selected
urban community Bangalore |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K R RAJANI |
| Designation |
PhD SCHOLAR |
| Affiliation |
RR Nursing Institutions Bangalore |
| Address |
Medical surgical nursing department RR Nursing Institutions 43/3 Rajareddy Layout Medaralli Chikkabanavara Myadarahalli Bangalore Karnataka
RR Nursing Institutions
Bangalore
KARNATAKA
560090
India |
| Phone |
9591233484 |
| Fax |
|
| Email |
rajani.prash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMU K |
| Designation |
DEAN CUM PRINCIPAL |
| Affiliation |
RR Nursing Institutions |
| Address |
RR Nursing Institutions 43/3 Rajareddy Layout Medarahalli Chikkabanavara Myadarahalli Bangalore Karnataka
RR Nursing Institutions
Bangalore
KARNATAKA
560090
India |
| Phone |
9448175850 |
| Fax |
|
| Email |
ramu5janu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMU K |
| Designation |
DEAN CUM PRINCIPAL |
| Affiliation |
RR Nursing Institutions |
| Address |
RR Nursing Institutions 43/3 Rajareddy layout Medaralli Chikkabanavara Myadarahalli Bangalore Karnataka
RR Nursing Institutions
Bangalore
KARNATAKA
560090
India |
| Phone |
9448175850 |
| Fax |
|
| Email |
ramu5janu@gmail.com |
|
|
Source of Monetary or Material Support
|
| PHC Uttarahalli Bangalore karnataka 560090 |
|
|
Primary Sponsor
|
| Name |
K R RAJANI PhD SCHOLAR |
| Address |
RR NURSING INSTITUTIONS 43/3 RAJAREDDY LAYOUT CHIKKABANAVARA MYADARAHALLI BENGALURU KARANATAKA 560090 |
| Type of Sponsor |
Research institution |
|
|
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 |
| K R RAJANI |
Primary health centre Uttarahalli Bangalore |
C-3 Uttarahalli Main Rd Simhadri layout Uttarahalli Hobli Bengaluru Karnataka India 560061
Bangalore
KARNATAKA |
9591233484
rajani.prash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RR NUTRSING INSTITUTIONS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Healthy life style |
Diet for 30 minutes |
| Intervention |
physical exercises |
walking
jogging
cycling
swimming for 25 minutes |
| Comparator Agent |
standard care |
As per hospital policy |
| Intervention |
yoga |
Uttanasana (Standing forward bend pose)
Viparita Karani (Legs-up-the-wall pose)
Adho mukha svanasana (Downward-facing dog pose)
Pashchimottanasana (Seated Forward Bend Pose)
Setu Bandhasana (Bridge pose)
for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Hypertensive patients who have history of blood pressure more than 20 yrs
Who have Blood cholesterol level more than 200 mg/dl
Type 1 hypertensive patients are selected for prevention of vascular complications
Type 2 hypertensive patients are selected for management of vascular complications
|
|
| ExclusionCriteria |
| Details |
Absence at the time of intervention session
Hypertensive patients who have attended any training programme on prevention Vascular Complications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comprehensive nursing care module will enhance the awareness of control of hypertension that further helps in the prevention of vascular complication among hypertensive patients. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comprehensive nursing care module will be effective in prevention of complications among hypertensive patients |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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 2 |
|
Date of First Enrollment (India)
|
22/05/2024 |
| 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 Yet Recruiting |
| 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
|
Comprehensive nursing care module will be effective in prevention and management of complications among hypertensive patients |