Viewing Study NCT06625463



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06625463
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-01

Brief Title: Development and Implementation Model of Home Based Cardiac Rehabilitation With Family Empowerment Approach in Patient With ACS HBCR in ACS
Sponsor: None
Organization: None

Study Overview

Official Title: Development and Implementation Model of Home Based Cardiac Rehabilitation With Family Empowerment Approach in Patient With ACS HBCR in ACS
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HBCR in ACS
Brief Summary: 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

1 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
2 Aged 18-65 years old participants were selected with age variations representing young adults adults and the elderly
3 Patients with first experience of SCA participants were selected whether they had undergone PCI or not
4 Patients living with family and family involved in the patient care process
5 Physical condition allows for interviews physical condition is evidenced by examination of stable vital signs diastolic BP

ampgt90 systolic amplt150 mmhg N 60-100xmin 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

1 Perform walking exercises as prescribed
2 Implement diets and stress management according to the module
3 Quit smoking
4 Medication compliance
5 visit the clinic to see a cardiologist undergo a 6-minute walk test
Detailed Description: How to enroll patients as research subjects Inpatients

1 The research team determines SKA patients who fit the study criteria
2 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
3 The room nurse will ask the patients willingness to be involved in the study
4 The patient signs the Informed consent
5 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
6 The nurse will give the prospective research subject identification card to the family and convey it to the outpatient clinic nurse

Outpatients

1 The research team draws data from medical records and determines appropriate outpatients With criteria
2 The research team gave a list of patients who could be used as research subjects to the outpatient nurse on duty
3 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
4 The room nurse will ask for the patients willingness to be involved in the study
5 The patient signs the Informed consent

Intervention HBCR with FCEM approach

1 Baseline measurement and entry test stage
2 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
3 Patients and families will receive the HBCR module which consists of a guidebook and educational video at the beginning of the counselling education session
4 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
5 Family-centered empowerment education stage

Explain the threat of ACS signs and symptoms clinical manifestations complications treatment and follow-up care risk factor control and the role of the family in home-based cardiac rehabilitation all families in the intervention group
Patients and families are guided by 1 facilitator In the group an intervention to increase self-efficacy was conducted by exploring problems that might arise in advanced care and then exploring joint solutions to these problems
Interventions to improve self-esteem and family participation were conducted Family members were educated based on the distributed module on controlling the risk of SCA patients in cardiac rehabilitation practiced how to accompany and monitor patients in cardiac rehabilitation Given positive reinforcement and feedback The group also ensures the family39s correct understanding in managing cardiac rehabilitation at home through a question and answer session
The facilitator evaluates the process and results of the stages that have been carried out to family members
6 12 weeks Home-based Cardiac Rehabilitation

1 The hbcr session is 12 weeks the patient will be seen by the cardiologist at weeks 1 6 12 During the 12-week intervention process the cardiologist in charge of the patient is the same cardiologist who performed the risk assessment examination on the patient determining the activity based on the first 6MWT test performed by the patient During the intervention process the facilitating nurse will report to the cardiologist in charge if there is any deterioration in the patiens condition in terms of vital signs and activities
2 Smoking diet and stress management counseling was conducted at the beginning of the session and follow-up by the nurse every 2 weeks in month 1 and every 4 weeks in the following month in the form of follow-up per video callhome visit Visit every 4 weeks to the cardiologist
3 Physical exercise is done 3 times a week 1 session of 30-40 minutes Patients can choose from jogging cycling weight lifting or aerobic exercise Each exercise session consists of 5 minutes of warm-up 30 minutes of core exercise and 5 minutes of cool-down Patients and families are given a video on the direction of the physical exercise to be performed Each exercise is accompanied by the family to monitor the patients HR complaints during the exercise session
4 The family reports HR and complaints during exercise immediately after the exercise is performed
5 The family reports daily diet exercise frequency complaints on the form provided

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

1 Informed consent is given in detail clearly and easily understood by patients and families
2 Confidentiality of patient and family data
3 Patients and families have the right to resign during the research process
4 Families are trained and enabled to provide home-based cardiac rehabilitation assistance to patients before the intervention is carried out
5 The activity plan given to patients is in accordance with their abilities as measured by the 6MWT test Patients who participated were patients with mild and moderate categories
6 There is one cardiologist who is in charge of the intervention and a nurse facilitator who will conduct daily monitoring through g forms monitoring every two weeks through video calls or home visits Nurse facilitators have previously been trained
7 There is a prepared flow in case of an emergency situation by coordinating with the nearest health care centre to the patient

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None