| CTRI Number |
CTRI/2024/05/068220 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing Protocol on Prevention of Cardiovascular Disease] |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effectiveness of Nursing Protocol on Prevention of Cardiovascular Disease on the risk of developing CVDs among People living with HIV (PLHIV), attending Antiretroviral Therapy (ART) Centre, PGIMER Chandigarh 2023- 2024: A prospective Cohort. |
|
Scientific Title of Study
|
A study to assess the effectiveness of Nursing Protocol on Prevention of Cardiovascular Disease on the risk of developing CVDs among People living with HIV (PLHIV) attending Antiretroviral Therapy (ART) Centre PGIMER Chandigarh 2023- 2024: A prospective Cohort. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandra Koch |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
NINE, PGIMER, Chandigarh, Room no. 2089.
NINE, PGIMER, Chandigarh, Room number 2089.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7085554267 |
| Fax |
160012 |
| Email |
chandrakoch3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandra Koch |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
NINE, PGIMER, Chandigarh, Room Number 2089.
NINE, PGIMER, Chandigarh, Room Number 2089.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7085554267 |
| Fax |
160012 |
| Email |
chandrakoch3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chandra Koch |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
NINE, PGIMER, Chandigarh, Room number 2089.
NINE, PGIMER, Chandigarh, Room number 2089.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7085554267 |
| Fax |
160012 |
| Email |
chandrakoch3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded, Antiretroviral Therapy Centre, PGIMER, Chandigarh, Room Number 2019. |
|
|
Primary Sponsor
|
| Name |
Chandra Koch |
| Address |
NINE, PGIMER, Chandigarh |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Ms Chandra Koch |
Antiretroviral therapy centre PGIMER Chandigarh |
Antiretroviral therapy centre PGIMER Chandigarh
Chandigarh
CHANDIGARH |
07085554267
chandrakoch3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I709||Other and unspecified atherosclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Nursing-protocol on prevention
of cardiovascular disease" |
Nursing-protocol on prevention
of cardiovascular disease. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to Participate in the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Risk of developing Cardiovascular Disease among People Living With HIV
Follow at 4 weeks and 12 weeks. |
Risk of developing Cardiovascular Disease among People Living With HIV
Follow at 4 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk of developing Cardiovascular Disease among People Living With HIV |
3 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
08/09/2024 |
| Date of First Enrollment (Global) |
01/07/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)
|
Early Intervention and control of cardiovascular risk are made possible by early detection. To prevent or lessen the effects of cardiovascular illnesses, this may entail constant monitoring, and lifestyle changes. The study can add important information to the corpus of knowledge already available in the scientific community about the relationship between HIV and cardiovascular health. Clinical recommendations and future research may benefit from this knowledge. The results have the potential to influence healthcare policies, enhance patient outcomes. |