| CTRI Number |
CTRI/2024/07/070315 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Nurse Led Community Field Trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nurse Led Cardiac Rehabilitation package on selected Biophysiological among Patients with Hypertension. |
|
Scientific Title of Study
|
The effectiveness of Nurse Led Cardiac Rehabilitation package on selected Biophysiological parameters among Patients with Hypertension in the selected Rural areas of Anand District of Gujarat State a Randomized Control Trial. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankitkumar Christian |
| Designation |
Assistant Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing,Charotar University of Science and Technology |
| Address |
Room No. 204,
Community Health Nursing Laboratory,Manikaka Topawala Institute of Nursing, CHARUSAT Campus, Off. Nadiad-Petlad Highway, Changa-388421, Gujarat
Anand
GUJARAT
388421
India |
| Phone |
9099698436 |
| Fax |
|
| Email |
ankitchristian68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankitkumar Christian |
| Designation |
Assistant Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing,Charotar University of Science and Technology |
| Address |
Room No. 204,
Community Health Nursing Laboratory,
Manikaka Topawala Institute of Nursing, CHARUSAT Campus, Off. Nadiad-Petlad Highway, Changa-388421, Gujarat
Anand
GUJARAT
388421
India |
| Phone |
9099698436 |
| Fax |
|
| Email |
ankitchristian68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Sharma |
| Designation |
The Principal cum Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing, CHARUSAT |
| Address |
Room 101,
Principal Office,
Manikaka Topawala Institute of Nursing, CHARUSAT Campus, Off. Nadiad-Petlad Highway, Changa-388421, Gujarat.
Anand
GUJARAT
388421
India |
| Phone |
8140364743 |
| Fax |
|
| Email |
anilsharma.nur@charusat.ac.in |
|
|
Source of Monetary or Material Support
|
| Primary Health Centre,
Bandhani,
Taluk: Petlad,
District: Anand,
State: Gujarat,
Pin Code:388410,
Country: India |
| Primary Health Centre,
Piplav,
Taluk: Sojitra,
District: Anand,
State: Gujarat,
Pin Code:388460,
Country: India |
| Primary Health Centre,
Sihol,
Taluk: Petlad,
District: Anand,
State: Gujarat,
Pin Code:388130,
Country: India |
|
|
Primary Sponsor
|
| Name |
Nill |
| Address |
Nill |
| Type of Sponsor |
Other [Nill] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan Rabari |
Primary Health Centre |
Village: Sihol,
Taluk: Petlad,
District: Anand,
State: Gujarat,
Pin Code:388130,
Country: India
Anand
GUJARAT |
7567870138
-
phcsihol.health.anand@gmail.com |
| Dr Janvi Shah |
Primary Health Centre, |
Village: Bandhani,
Taluk: Petlad,
District: Anand,
State: Gujarat,
Pin Code:388410,
Country: India
Anand
GUJARAT |
7567870140
-
phcbandhani.health.anand@gmail.com |
| Dr Twinkle Macwan |
Primary Health Centre, |
Village: Piplav,
Taluk: Sojitra,
District: Anand,
State: Gujarat,
Pin Code:388460,
Country: India
Anand
GUJARAT |
7359006625
-
phcpiplav.health.anand@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-CHARUSAT |
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 |
Nurse Led Cardiac Rehabilitation Package |
It has 6 components ( therapeutic communication, adherence to medical follow up, compliance with medications, physical exercise, dietary modification, specific strategies) which helps to control selected biophysiological parameters.
2 sessions of 30 min each spaced out over a period of 3 weeks. |
| Comparator Agent |
Regular health care services |
routine health services provided by Primary health center |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
People above 18 years of age.
People residing under selected rural areas of Anand district.
People who are able to understand and speak Guajarati or Hindi or English language.
People diagnosed with hypertension and taking antihypertensive medicine prescribed by physician.
Hypertensive people who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Having other serious illnesses such as cancer, hepatitis, HIV-AIDS, TB, Asthma, COPD.
Bed ridden.
Mentally compromised.
Pregnant at the time of data collection.
Unwilling or unable to provide informed consent.
having contraindication with planned nurse lead intervention are not suitable for this study.
Currently participating in other intervention studies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Significant change in selected biophysiological parameters such as Blood pressure, BMI, RBS, Lipid Profile |
at baseline and at 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/06/2025 |
| Date of Study Completion (India) |
27/02/2026 |
| Date of First Enrollment (Global) |
01/06/2025 |
| Date of Study Completion (Global) |
27/02/2026 |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Title: "The Effectiveness of Nurse Led Cardiac Rehabilitation package on selected Biophysiological parameters among Patients with Hypertension in the selected Rural areas of Anand District of Gujarat State: A Randomized Control Trial." Objective:
To evaluate the effectiveness of nurse led cardiac rehabilitation package on selected biophysiological parameters in control and experimental group. Hypothesis: 1H0. There will be no significant difference on biophysiological parameters among patients with hypertension before and after administration of The Nurse lead cardiac rehabilitation package in control and experimental group at 0.05 level of significance.
|