跳至主要内容
临床试验/CTRI/2024/12/078580
CTRI/2024/12/078580尚未招募不适用

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.

Dainy Thomas1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
The primary outcomes will be medication adherence and adherence to CVD-related lifestyle practices,

研究概览

简要总结

“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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients’ willingness to participate
  • Patients who can read/ understand Hindi/English
  • Patients who are hemodynamically stable at the time of recruitment.
  • MI patients attending Cardiology O.P.D, A.I.I.M.S, Nagpur
  • Patient with New York Heart Association (NYHA) classification I, and II
  • Patients diagnosed with MI and undergone angioplasty.
  • Patients residing in or near Nagpur
  • Having access to a telephone
  • Not suffering from any severe and life-threatening diseases 10.Having the ability to perform daily routine activities.

排除标准

  • Patients who have undergone CABG
  • Patients diagnosed with psychiatric disorders.
  • NYHA grade III or IV congestive heart failure (CHF)
  • Patients with any other chronic systemic illness like Cancer and Chronic Kidney Disease • Postoperative angina
  • Significant Left ventricular dysfunction (LVEF) less than 20 percentage
  • History of sustained VT or fibrillation
  • Incapable of self-monitoring
  • Myocardial ischemia with exercise
  • History of sustained life-threatening supraventricular arrhythmia • History of sudden cardiac arrest
  • Initial therapy of patients with automatic implantable cardioverter-defibrillator (AICD) or a rate-adaptive cardiac pacemaker
  • Not answering the telephone for more than three consecutive times.

结局指标

主要结局

The primary outcomes will be medication adherence and adherence to CVD-related lifestyle practices,

时间窗: 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,

时间窗: 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),

时间窗: 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.

时间窗: Time points of outcome assessment are at baseline, 4 weeks, 12 weeks and 24 weeks after angioplasty

次要结局

  • 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),)

研究者

发起方
Dainy Thomas
申办方类型
Other [self]

研究点 (1)

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