CTRI Number |
CTRI/2024/12/078580 [Registered on: 26/12/2024] Trial Registered Prospectively |
Last Modified On: |
24/12/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive Screening Other (Specify) [NURSE LED MYOCARDIAL INFARCTION FOLLOW-UP CLINIC ] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Evaluating the Impact of a Nurse Led Follow Up Clinic on Health Outcomes of Myocardial Infarction Patients and Their Caregivers in a Hospital setting |
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of Nurse led Myocardial infarction follow up clinic on selected outcome variables of patients and caregivers of patients with Myocardial Infarction attending Cardiology OPD in a tertiary care hospital. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dainy Thomas |
Designation |
Nursing Tutor cum Deputy Nursing Superintendent |
Affiliation |
All India Institute of Medical Sciences Nagpur |
Address |
College of Nursing,
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra Nursing Superintendent Office, All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra Nagpur MAHARASHTRA 441108 India |
Phone |
9810785066 |
Fax |
|
Email |
dainyelby@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dainy Thomas |
Designation |
Nursing Tutor cum Deputy Nursing Superintendent |
Affiliation |
College of Nursing All India Institute of Medical Sciences Nagpur |
Address |
College of Nursing,
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra Nursing Superintendent Office
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra Nagpur MAHARASHTRA 441108 India |
Phone |
9810785066 |
Fax |
|
Email |
dainyelby@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dainy Thomas |
Designation |
Nursing Tutor cum Deputy Nursing Superintendent |
Affiliation |
All India Institute of Medical Sciences Nagpur |
Address |
College of Nursing,
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra Nursing Superintendent Office,
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra Nagpur MAHARASHTRA 441108 India |
Phone |
9810785066 |
Fax |
|
Email |
dainyelby@gmail.com |
|
Source of Monetary or Material Support
|
Employed as Nursing Tutor cum Deputy Nursing Superintendent,
College of Nursing,
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra,
India
Pin 441108 |
|
Primary Sponsor
|
Name |
Dainy Thomas |
Address |
Nursing Tutor cum Deputy Nursing Superintendent,
College of Nursing,
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra |
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 |
Dr Prof Arijit Kumar Ghosh |
All Institute of Medical Sciences |
Cardiology OPD,
All India Institute of Medical Sciences,
MIHAN,
Plot 2,
Sector 20,
Nagpur,
Maharashtra Nagpur MAHARASHTRA |
9810785066 7099096717 dainyelby@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee AIIMS Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NURSE LED MYOCARDIAL INFARCTION FOLLOW UP CLINIC |
If the subject agree to participate in the study, they will be selected according to inclusion and exclusion criteria. After that, according to the computer-generated number table, the group will be decided. After that baseline data will be collected.
In group A: Group A subjects will be given both Nurse- Led Myocardial Infarction follow-up care and Cardiologist care. Nurse- Led Myocardial Infarction follow-up clinic includes comprehensive structured Nurse-led counseling, Myocardial Infarction Nurse Discharge Booklet that is given to the patient during the baseline visit in Cardiology OPD and the telephonic reminder calls till 6 months by the nurse researcher.
Myocardial Infarction Nurse Discharge Booklet will be given to every individual contains General information about Coronary Artery Disease and Cardio Vascular Disease-specific care and Checklist to self-record Follow-up dates, Medications, Heart rate, Blood Pressure, FBS, Physical Activity and Diet maintained at home.
Health teaching will be given one to one which includes information about CAD, risk factors, Clinical Manifestations of Myocardial Infarction, Diagnostic Investigations, Treatment, CVD-related lifestyle practices, medication adherence, blood glucose, and blood pressure control and warning signs of complications of Myocardial Infarction which are to be identified earlier and treated.
Telephonic reminder calls regarding self-care management will be done once a month (9am to 5pm) for approximately 5-10 min for 3 months and follow-up visits’ reminder 2 days prior to the scheduled OPD visit.
During this participant will be asked few questions regarding his/her Heart Rate, Blood Pressure, symptoms, activities, drug compliance and re-admission and the researcher will clarify any doubts of the participant and reinforcement will be done regarding intervention protocol.
• The experimental group Myocardial Infarction patients along with their caregivers will receive individualized teaching at Cardiology OPD, AIIMS and reinforcement of instructions as needed while attending the Nurse-led Myocardial Infarction clinic at baseline, 1 month, 3 month and 6 months’ visits.
• Patients of the intervention group are reinforced telephonically once a month to continue the advice and to come for follow-up (2 days prior to the appointment) in OPD AIIMS at 1 month, 3 month and 6 months. On each follow up visit, the outcomes will be assessed by the researcher. They can also attend the Cardiologists’ OPD during the same visits.
In group B: In group B patient will be given usual care by the cardiologist and telephonic contact made by researcher once a month only to find out any mortality or readmission.
|
Comparator Agent |
STANDARD CARE |
The control group participants will be receiving the standard care and they will be followed up in the Cardiology OPD by the Cardiologist only. The outcomes will be assessed by the assessor at baseline, 1month, 3 months and 6 months after the angioplasty. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients’ willingness to participate
2. Patients who can read/ understand Hindi/English
3. Patients who are hemodynamically stable at the time of recruitment.
4. MI patients attending Cardiology O.P.D, A.I.I.M.S, Nagpur
5. Patient with New York Heart Association (NYHA) classification I, and II
6. Patients diagnosed with MI and undergone angioplasty.
7. Patients residing in or near Nagpur
8. Having access to a telephone
9. Not suffering from any severe and life-threatening diseases
10.Having the ability to perform daily routine activities. |
|
ExclusionCriteria |
Details |
1. Patients who have undergone CABG
2. Patients diagnosed with psychiatric disorders.
3. NYHA grade III or IV congestive heart failure (CHF)
4. Patients with any other chronic systemic illness like Cancer and Chronic Kidney Disease
• Postoperative angina
5. Significant Left ventricular dysfunction (LVEF) less than 20 percentage
6. History of sustained VT or fibrillation
7. Incapable of self-monitoring
8. Myocardial ischemia with exercise
9. History of sustained life-threatening supraventricular arrhythmia
• History of sudden cardiac arrest
10. Initial therapy of patients with automatic implantable cardioverter-defibrillator (AICD) or a rate-adaptive
cardiac pacemaker
11. Not answering the telephone for more than three consecutive times |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The primary outcomes will be medication adherence and adherence to CVD-related lifestyle practices,
while the secondary outcomes will be patient satisfaction, changes in biophysiological (ECG, Blood pressure,
Ejection fraction and heart rate) and biochemical parameters (Lipid profile, RFT, FBS, HbA1C, and CRP),
burden of the caregivers of the patients, and the presence of complications. |
Time points of outcome assessment are at baseline, 4 weeks, 12 weeks and 24 weeks after angioplasty |
|
Secondary Outcome
|
Outcome |
TimePoints |
The secondary outcomes will be patient satisfaction, changes in biophysiological (ECG, Blood pressure,
Ejection fraction and heart rate) and biochemical parameters (Lipid profile, RFT, FBS, HbA1C, and CRP),
burden of the caregivers of the patients, and the presence of complications. |
The outcomes will be assessed at
baseline (before discharge), after 1 month, 3 months and 6 months after discharge. |
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
06/01/2025 |
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="1" Days="1" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dainyelby@gmail.com].
- For how long will this data be available start date provided 02-02-2026 and end date provided 02-02-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
“A randomised control trial to assess the effectiveness of Nurse-led Myocardial infarction follow-up clinic on selected outcome variable of patients and caregivers of patients with Myocardial infarction attending Cardiology OPD in a tertiary care hospitalâ€. The purpose of the study is to assess the effectiveness of Nurse-led Myocardial infarction follow-up clinic on selected outcome variable of patients and caregivers of patients with Myocardial infarction attending Cardiology OPD in a tertiary care hospital. The outcome variables include medication adherence, CVD related lifestyle factors, complications, biochemical and biophysiological profile, patient satisfaction and the caregiver burden of the patients. The study’s findings will help understand the benefits of having a healthy lifestyle and modifying the risk factors to prevent further cardiovascular events after a myocardial infarction. The post PTCA patients getting admitted in the ward will be scrutinised based on the inclusion and exclusion criteria and subjects will be randomly selected with the help of a computerised randomization approach. After obtaining the informed consent, SNOSE technique will be used for allocation concealment by the Senior Nurse. The experimental group will receive discharge counselling and a discharge booklet (to address gaps in knowledge and to make it easier for the patient to remember important and relevant points) in the ward in a specified room where there will be a one-to-one interaction with the patient and caregiver. The Nurse researcher will follow- up the patient till discharge and give reinforcement of expected behaviors. The Senior Nursing officer gets the baseline data while the subjects are in the ward. Patients of the intervention group also receive telephonic reinforcement by the Nurse researcher once a month till 3 months and reminder to come for follow-up with the blood investigations report in OPD AIIMS Nagpur at 1 month, 3 month and 6 months. On the upcoming OPD visits, the research associate will send the Experimental group patient to the Nurse-led MI follow-up clinic and then to the Cardiologist’s clinic, while the control group subject will be sent to the Cardiologist’s clinic only. On each follow up visit, the outcomes (O2, O3 and O4) will be assessed. The experimental group patients will be able to contact the researcher anytime for any queries or clarifications. All the relevant information will be given in written form to the caregiver, for reference at home and the checklist is encouraged to be filled out to avoid loss of information due to memory loss during long-term follow-up. |