Development and Implementation Model of Home Based Cardiac Rehabilitation With Family Empowerment Approach in Patient With ACS (HBCR in ACS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- health related quality of life
研究概览
简要总结
The aim of this clinical trial is to determine whether home-based cardiac rehabilitation with a family empowerment approach can help acute coronary syndrome patients recover. The main questions to be answered are:
- Does home-based cardiac rehabilitation with a family approach effective in patients with acute coronary syndrome to improve health-related quality of life and peak Vo2? Researchers will compare with usual care to see if home-based cardiac rehabilitation with a family approach is more effective for improving health-related quality of life and peak Vo2 in ACS patients.
Patient inclusion criteria
- Patients with acute coronary syndrome who had undergone hospitalization, with a minimum home care time of 3 months and a maximum of 1 year, calculated from the day of discharge from the hospital until the time of the interview.
- Aged 18-65 years old, participants were selected with age variations representing young adults, adults and the elderly.
- Patients with first experience of SCA, participants were selected whether they had undergone PCI or not.
- Patients living with family and family involved in the patient care process.
- Physical condition allows for interviews. physical condition is evidenced by examination of stable vital signs (diastolic BP
>90, systolic <150 mmhg; N: 60-100x/min; S: 36-380c, no pain). Psychological condition does not show symptoms of depression as measured by the Patient Health Questionnaire-9 instrument. 6. Willing to participate in the study.
Participants will:
For 12 weeks
- Perform walking exercises as prescribed
- Implement diets and stress management according to the module
- Quit smoking
- Medication compliance
- visit the clinic to see a cardiologist, undergo a 6-minute walk test
详细描述
How to enroll patients as research subjects Inpatients
- The research team determines SKA patients who fit the study criteria
- The room nurse helps explain to the patient to be involved in the study, explaining the purpose, benefits, procedures of the study and possible risks
- The room nurse will ask the patients willingness to be involved in the study.
- The patient signs the Informed consent
- The nurse explains the interventions that will be provided after informed consent during the first hospital visit (details of the interventions are in the next section).
- The nurse will give the prospective research subject identification card to the family and convey it to the outpatient clinic nurse.
Outpatients
- The research team draws data from medical records and determines appropriate outpatients. With criteria
- The research team gave a list of patients who could be used as research subjects to the outpatient nurse on duty
- The nurse will help explain to the patient to be involved in the study, explaining the purpose, benefits, procedures of the study and the risks that may occur
- The room nurse will ask for the patients willingness to be involved in the study.
- The patient signs the Informed consent
Intervention HBCR with FCEM approach
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking could not be done for researchers and research subjects, but was done for enumerators and assessors of research outcomes. During the data collection and measurement process, enumerators and cardiologists did not know the allocation of research subjects. Likewise, the statistician who will process the data does not know the allocation for each research data.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute coronary syndrome who have undergone hospitalization, with a minimum home care time of 3 months and a maximum of 1 year, calculated from the day of discharge from the hospital until the time of interview.
- •Aged 18-65 years, participants were selected with age variations representing young adults, adults and the elderly.
- •Patients with first experience of SCA, participants were selected whether they had undergone PCI or not.
- •Patients living with family and family involved in the patient care process.
- •Physical condition allows for interviews. physical condition is evidenced by examination of stable vital signs (diastolic BP
- •>90, systolic <150 mmhg; N: 60-100x/min; S: 36-380c, no pain). Psychological condition does not show symptoms of depression as measured by the Patient Health Questionnaire-9 instrument.
- •Willing to participate in the study.
排除标准
- •Patients with comorbidities that require routine medication such as Diabetes Mellitus, hypertension, renal failure
结局指标
主要结局
health related quality of life
时间窗: From enrollment to the end of treatment at 12 weeks
Individuals perception of their level of health, current condition which includes physical, psychological and social dimensions, will be measured with MacNew Heart questionnaire. scored from 1 (low HRQOL) to 7 (high HRQOL). The maximum possible score in any domain is 7
peak Vo2
时间窗: From enrollment to the end of treatment at 12 weeks
peak vo2 achieved based on 6minute walk test, in ml/kg/min
次要结局
未报告次要终点
研究者
Eva Marti,Ns.,M.Kep
Mrs.Eva Marti.,S.Kep.,Ns.,M.Kep
Gadjah Mada University