Development and Implementation Model of Home Based Cardiac Rehabilitation With Family Empowerment Approach in Patient With ACS (HBCR in ACS)

NCT06625463 | Recruiting DMC

• 1 other identifier: Eva marti 1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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. 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. 2.Aged 18-65 years old, participants were selected with age variations representing young adults, adults and the elderly.
3. 3.Patients with first experience of SCA, participants were selected whether they had undergone PCI or not.
4. 4.Patients living with family and family involved in the patient care process.
5. 5.Physical condition allows for interviews. physical condition is evidenced by examination of stable vital signs (diastolic BP
6. 6.Willing to participate in the study.
7. 7.Perform walking exercises as prescribed
8. 8.Implement diets and stress management according to the module
9. 9.Quit smoking
10. 10.Medication compliance
11. 11.visit the clinic to see a cardiologist, undergo a 6-minute walk test

Conditions

Home Based Rehabilitation; Acute Coronary Syndromes

Keywords

home based cardiac rehabilitation; FCEM; acute coronary syndromes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental arm

EXPERIMENTAL

Experimental arm receive 12 week home based cardiac rehabilitation include physical exercise, dietary management, smoking cessation and stress management

Behavioral: Home based cardiac rehabilitation

control arm

NO INTERVENTION

Control arm receive usually care

Interventions

Home based cardiac rehabilitation BEHAVIORAL

12 week home based cardiac rehabilitation include Physical exercise, dietary management, smoking cessation and stress management

Experimental arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with comorbidities that require routine medication such as Diabetes Mellitus, hypertension, renal failure

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (2)

Gadjah Mada University

Sleman, Special Region of Yogyakarta, Indonesia

NOT YET RECRUITING

Rsup Dr Sardjito

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

RECRUITING

Related Publications (3)

• 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.

  PMID: 34611066 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.

  PMID: 17576872 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.

  PMID: 35964767 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Anggoro Budi Hartopo, PhD

  Gadjah Mada University

  STUDY DIRECTOR

Central Study Contacts

Eva Marti, M.Kep

CONTACT

+628963-6598-725; evamarti85@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs.Eva Marti.,S.Kep.,Ns.,M.Kep

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: January 1, 2025
• Primary Completion: June 10, 2025
• Study Completion: September 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)