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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.
Willing to participate in the study.
Participants will:
For 12 weeks
How to enroll patients as research subjects Inpatients
Outpatients
Intervention HBCR with FCEM approach
Baseline measurement and entry test stage
At this stage, peak VO2 measurement is taken, measured based on 6MWT travel time. The results of the 6-minute walk test will be used to determine the intensity of home exercise to be performed. The research subjects will undergo ECG examination before and after the 6MWT to ensure the following
Patients and families will receive the HBCR module, which consists of a guidebook and educational video at the beginning of the counselling education session.
Patients and families receive a video by a cardiologist explaining. disease and treatment, a video by a psychologist on stress management, a dietician on food management, aiming to maintain weight and blood sugar levels and a video on smoking cessation guidance by a smoking counsellor.
Family-centered empowerment education stage
12 weeks Home-based Cardiac Rehabilitation
During the intervention period, the family reported daily diets, medication adherence and exercise activities as well as HR during exercise through a daily google form that would be monitored by the facilitating nurse.
The control group will receive education on the components of medication adherence, exercise, smoking behaviour, diet, and stress management for 1 session.
Forms of protection for patients and families:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Experimental arm receive 12 week home based cardiac rehabilitation include physical exercise, dietary management, smoking cessation and stress management |
|
| control arm | No Intervention | Control arm receive usually care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home based cardiac rehabilitation | Behavioral | 12 week home based cardiac rehabilitation include Physical exercise, dietary management, smoking cessation and stress management |
|
| Measure | Description | Time Frame |
|---|---|---|
| health related quality of life | 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 | From enrollment to the end of treatment at 12 weeks |
| peak Vo2 | peak vo2 achieved based on 6minute walk test, in ml/kg/min | From enrollment to the end of treatment at 12 weeks |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Marti, M.Kep | Contact | +628963-6598-725 | evamarti85@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anggoro Budi Hartopo, PhD | Gadjah Mada University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gadjah Mada University | Not yet recruiting | Sleman | Special Region of Yogyakarta | Indonesia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34611066 | Background | Basuki N, El-Ansary D, Hofer S, Dwiputra B, Nualnim N. The Validity and Reliability of the MacNew Heart Disease Health Related Quality of Life Questionnaire: The Indonesian Version. Acta Med Indones. 2021 Jul;53(3):276-281. | |
| 17576872 | Background | Arena R, Myers J, Williams MA, Gulati M, Kligfield P, Balady GJ, Collins E, Fletcher G; American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing. Assessment of functional capacity in clinical and research settings: a scientific statement from the American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology and the Council on Cardiovascular Nursing. Circulation. 2007 Jul 17;116(3):329-43. doi: 10.1161/CIRCULATIONAHA.106.184461. Epub 2007 Jun 18. No abstract available. |
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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.
| Rsup Dr Sardjito |
| Recruiting |
| Yogyakarta |
| Special Region of Yogyakarta |
| 55281 |
| Indonesia |
|
| 35964767 | Background | Alhani F, Asghari-Jafarabadi M, Norouzadeh R, Rahimi-Bashar F, Vahedian-Azimi A, Jamialahmadi T, Sahebkar A. The effect of family-centered empowerment model on the quality of life of adults with chronic diseases: An updated systematic review and meta-analysis. J Affect Disord. 2022 Nov 1;316:140-147. doi: 10.1016/j.jad.2022.07.066. Epub 2022 Aug 11. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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