Home Based RehabilitationHBCR in ACSNCT06625463
Development and Implementation Model of Home Based Cardiac Rehabilitation With Family Empowerment Approach in Patient With ACS (HBCR in ACS)
A study testing Home based cardiac rehabilitation in people with Home Based Rehabilitation and Acute Coronary Syndromes, run by Gadjah Mada University at 2 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Home Based Rehabilitation, Acute Coronary Syndromes
- What is being tested?
- Home based cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with comorbidities that require routine medication such as Diabetes Mellitus, hypertension, renal failure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites, 2 recruiting
- Not yet recruiting
Gadjah Mada University
Sleman, Special Region of Yogyakarta
- Recruiting
Rsup Dr Sardjito
Yogyakarta, Special Region of Yogyakarta, 55281
Anggoro Budi Hartopo, Phd, (0274)587333, a_bhartopo@ugm.ac.id
Eva Marti
About this study
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.
Read more
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 \&gt;90, systolic \&lt;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
- 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
Read the detailed description
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
- 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
- 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 family\'s 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.
- 12 weeks Home-based Cardiac Rehabilitation
- 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.
- 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 call/home visit). Visit every 4 weeks to the cardiologist
- 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.
- The family reports HR and complaints during exercise, immediately after the exercise is performed
- 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:
- Informed consent is given in detail, clearly and easily understood by patients and families.
- Confidentiality of patient and family data
- Patients and families have the right to resign during the research process.
- Families are trained and enabled to provide home-based cardiac rehabilitation assistance to patients before the intervention is carried out.
- 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.
- 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.
- There is a prepared flow in case of an emergency situation, by coordinating with the nearest health care centre to the patient.
- Being tested
- Home based cardiac rehabilitation
- Keywords
- home based cardiac rehabilitation, FCEM, acute coronary syndromes
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based cardiac rehabilitationBehavioural
12 week home based cardiac rehabilitation include Physical exercise, dietary management, smoking cessation and stress management
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Experimental arm receive 12 week home based cardiac rehabilitation include physical exercise, dietary management, smoking cessation and stress management Receives: Behavioral: Home based cardiac rehabilitation |
| control arm | No intervention | Control arm receive usually care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 weeks
peak Vo2
peak vo2 achieved based on 6minute walk test, in ml/kg/min
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Jan 2025
- Primary completion10 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Home Based RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Marti,Ns.,M.Kep, Gadjah Mada University
- Investigators
- Anggoro Budi Hartopo, PhD, Study director, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625463
- Sponsor's protocol ID
- Eva marti 1
- Acronym
- HBCR in ACS
- Status last verified
- Jun 2025
- First submitted
- 1 Oct 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34611066Arena 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.
PubMed 17576872Alhani 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.
PubMed 35964767
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation Model of Home Based Cardiac Rehabilitation With Family Empowerment Approach in Patient With ACS (HBCR in ACS)
- ClinicalTrials.gov ID
- NCT06625463
- Acronym / sponsor ID
- HBCR in ACS / Eva marti 1
- Keywords
- home based cardiac rehabilitation, FCEM, acute coronary syndromes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \&gt;90, systolic \&lt;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
- 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
Detailed description
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
- 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
- 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 family\'s 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.
- 12 weeks Home-based Cardiac Rehabilitation
- 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.
- 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 call/home visit). Visit every 4 weeks to the cardiologist
- 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.
- The family reports HR and complaints during exercise, immediately after the exercise is performed
- 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:
- Informed consent is given in detail, clearly and easily understood by patients and families.
- Confidentiality of patient and family data
- Patients and families have the right to resign during the research process.
- Families are trained and enabled to provide home-based cardiac rehabilitation assistance to patients before the intervention is carried out.
- 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.
- 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.
- There is a prepared flow in case of an emergency situation, by coordinating with the nearest health care centre to the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: Home based cardiac rehabilitationExperimental 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with comorbidities that require routine medication such as Diabetes Mellitus, hypertension, renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based cardiac rehabilitation12 week home based cardiac rehabilitation include Physical exercise, dietary management, smoking cessation and stress management | Behavioural | Experimental arm |
Primary outcome
health related quality of life
Time frame: 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
Time frame: From enrollment to the end of treatment at 12 weeks
peak vo2 achieved based on 6minute walk test, in ml/kg/min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 34611066Basuki 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.
- Background: PubMed 17576872Arena 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.
- Background: PubMed 35964767Alhani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anggoro Budi Hartopo, PhD study director
Gadjah Mada University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based cardiac rehabilitation in people with Home Based Rehabilitation and Acute Coronary Syndromes, run by Gadjah Mada University at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Marti, M.Kep (+628963-6598-725, evamarti85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health related quality of life (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06625463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.