Evaluating the Impact of a Nurse Led Follow Up Clinic on Health Outcomes of Myocardial Infarction Patients and Their Caregivers in a Hospital setting

Not yet recruiting

• Conditions: Atherosclerosis of other arteries,

• Registration Number: CTRI/2024/12/078580
• Lead Sponsor: Dainy Thomas

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-12-24
• Study Start: 2025-06-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients’ willingness to participate 2.
• Patients who can read/ understand Hindi/English 3.
• Patients who are hemodynamically stable at the time of recruitment.
• 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.
• 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.

Exclusion Criteria

• Patients who have undergone CABG 2.
• Patients diagnosed with psychiatric disorders.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes will be medication adherence and adherence to CVD-related lifestyle practices,	Time points of outcome assessment are at baseline, 4 weeks, 12 weeks and 24 weeks after angioplasty
while the secondary outcomes will be patient satisfaction, changes in biophysiological (ECG, Blood pressure,	Time points of outcome assessment are at baseline, 4 weeks, 12 weeks and 24 weeks after angioplasty
Ejection fraction and heart rate) and biochemical parameters (Lipid profile, RFT, FBS, HbA1C, and CRP),	Time points of outcome assessment are at baseline, 4 weeks, 12 weeks and 24 weeks after angioplasty
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 Measures

Name	Time	Method
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),

Trial Locations

Locations (1)

All Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

All Institute of Medical Sciences

🇮🇳Nagpur, MAHARASHTRA, India

Dr Prof Arijit Kumar Ghosh

Principal investigator

9810785066

dainyelby@gmail.com