Effectiveness of App based lifestyle modification on metabolic profile ,self care compliance and quality of life of patients following Percutaneous coronary intervention - A randomized clinical trial .
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire
研究概览
简要总结
Objectives of the study are
1. To develop the IND HEART SURAKSHA app based on the need assessment from
patients, their families and experts.
2. To evaluate the effectiveness of the mobile app based lifestyle modification on self-care compliance, metabolic profile and quality of life.
Hypothesis
There will be significant difference in self care compliance ,metabolic profile and quality of life of the standard care group and the m.app based life style modification group at p<0.05 level .
Intervention
The newly developed and refined IND HEART SURAKSHA APP will be made available to the individual participant in the experimental arm from play store. The participants will be educated about the features of the app and demonstrated on its use while they are in the wards . Both the group participants will receive standard computer based education on the nature of CAD, PCI and required lifestyle modifications after PCI while they are in the cardiac wards but before discharge to home . They will also be supplemented with carry home instructions on home care and follow up. Regarding the medication timing ,dosages standard individualized instruction by the ward nurses will be carried out for both the groups .Both group of patients will be followed up telephonically in the first four weeks as part of routine transitional care
Plan for Data collection Procedure
After obtaining the informed consent ,background information will be obtained by individualized interview . Their clinical information regarding the PCI procedures will be extracted from the case sheets .The Biochemical parameters obtained also will be collected from the case sheet . Premorbid self care behaviors and Quality of life will be obtained using Self care questionaire and RAND SF 36 questionnaire respectively . One month later both the groups will be contacted when they come for follow up . They will be requested to complete the self care behavior questionnaire . Post test 2 and 3 will be completed by both the groups using the same techniques and questionnaire at 6 months and 12 months post PCI. Fasting biochemical parameters will be checked at 6 months and 12 moths post PCI Their physiological parameters such as weight, BP, Pulse , waist hip circumferences, 6 minutes walk test will be obtained by the investigators at baseline 1month, 6montha and 12 months post PCI .
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •Adult patients and above both male and female patients who are subjected to PCI .
- •Patients in the age group of 30 years too 70 years
- •Patients who are confident and willing to use android mobile
- •Literate patients who can read and write English or Tamil
- •Patients with or without diabetes and /or hypertension
- •Patients who has undergone PCI on elective or emergency basis
- •Irrespective of the number and type of stents.
排除标准
- •PCI Patients with Stroke / Bronchial Asthma
- •Patients with who had earlier CABG
- •Patients with severe LV dysfunction (EF less than 30% 4.
结局指标
主要结局
Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire
时间窗: Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire | • 2 .Objective measure of self care compliance to physical activity - 6 minutes walk test | • Metabolic profile – Fasting blood sugar, fasting cholesterol, HDL, LDL and triglycerides, Waist hip ratio measurement ,BP | • Log of pain and other distressing symptoms
• 2 .Objective measure of self care compliance to physical activity - 6 minutes walk test
时间窗: Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire | • 2 .Objective measure of self care compliance to physical activity - 6 minutes walk test | • Metabolic profile – Fasting blood sugar, fasting cholesterol, HDL, LDL and triglycerides, Waist hip ratio measurement ,BP | • Log of pain and other distressing symptoms
• Metabolic profile – Fasting blood sugar, fasting cholesterol, HDL, LDL and triglycerides, Waist hip ratio measurement ,BP
时间窗: Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire | • 2 .Objective measure of self care compliance to physical activity - 6 minutes walk test | • Metabolic profile – Fasting blood sugar, fasting cholesterol, HDL, LDL and triglycerides, Waist hip ratio measurement ,BP | • Log of pain and other distressing symptoms
• Log of pain and other distressing symptoms
时间窗: Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire | • 2 .Objective measure of self care compliance to physical activity - 6 minutes walk test | • Metabolic profile – Fasting blood sugar, fasting cholesterol, HDL, LDL and triglycerides, Waist hip ratio measurement ,BP | • Log of pain and other distressing symptoms
次要结局
- Quality of Life(Baseline - 3 days after PCI)
研究者
Madhavi S
KMCH College of Nursing