Acute Myocardial InfarctionNCT03428438
Initial Education for Rehabilitation and Motivation Program Following a Myocardial Infarction Via SMS or Hospital
A study testing Rehabilitation at home via SMS in people with Acute Myocardial Infarction, run by Hillel Yaffe Medical Center.
Trial summary
The innovation in this preliminary study is the use of message reminders in patients after myocardial infarction in stage I of rehabilitation (ie discharge from hospital) at home via SMS, compared with studies of patients undergoing cardiac rehabilitation (stage II)in the hospital physiotherapy department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Rehabilitation at home via SMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent Criteria for inclusion Patients after acute myocardial infarction admitted to the intensive care unit Patients who speak the Hebrew language Patients with a cell phone to receive a reminder using a message
Who cannot join
- Orthopedic or neurological problem that would prevent physical activity. A score lower than 24 in the MoCA test. High-risk patients.
- Complications: of myocardial infarction congestive heart failure, cardiogenic shock and / or ventricular arrhythmias.
- Angina or shortness of breath at rest. Decrease >1mm in the ST segment in the ECG.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Initial Education for Rehabilitation and Motivation Program Following a Myocardial Infarction. Rehabilitation Exercises at Home Via SMS or in the Hospital Physiotherapy Department
The innovation in this preliminary study is the use of message reminders in patients after myocardial infarction in stage I of rehabilitation (ie discharge from hospital) at home via SMS, compared with studies of patients undergoing cardiac rehabilitation (stage II)in the hospital physiotherapy department.
Read the detailed description
The first stage of rehabilitation begins during hospitalization. Motivation for the rehabilitation process for the patient. At this stage there will be preparation for release and guidance for the patient and their families regarding secondary prevention and return to domestic activity. This stage includes mobility, walking, controlled motility and gradual joint activation to maintain ranges and prevent complications from prolonged immobilization in bed.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Rehabilitation at home via SMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation at home via SMSOther
Also called Rehabilitation in hospital setting
Cardiac rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Study group SMS to home phone | Other | A physical reminder by a physiotherapist, and a daily reminder of physical exercise by SMS on weekdays A through E. Receives: Other: Rehabilitation at home via SMS |
| Controlled group hospital based | Other | Physical rehabilitation in the ward physiotherapist Receives: Other: Rehabilitation at home via SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac rehabilitation
Cardiac rehabilitation following heart attack following discharge
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects recruited will be randomized into two groups: one group of subjects (the study group) A physical reminder by a physiotherapist, and a daily reminder of physical exercise by SMS on weekdays A through E. The second group (the control group) will be given a routine training in the ward by a nurse and you will receive a weekly SMS message
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Avraham Shotan, Prof, Principal investigator, Hillel yaffe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428438
- Sponsor's protocol ID
- HYMC-0131-17
- Status last verified
- Jan 2018
- First submitted
- 29 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Education for Rehabilitation and Motivation Program Following a Myocardial Infarction. Rehabilitation Exercises at Home Via SMS or in the Hospital Physiotherapy Department
- ClinicalTrials.gov ID
- NCT03428438
- Acronym / sponsor ID
- HYMC-0131-17
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Feb 2018 (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 innovation in this preliminary study is the use of message reminders in patients after myocardial infarction in stage I of rehabilitation (ie discharge from hospital) at home via SMS, compared with studies of patients undergoing cardiac rehabilitation (stage II)in the hospital physiotherapy department.
Detailed description
The first stage of rehabilitation begins during hospitalization. Motivation for the rehabilitation process for the patient. At this stage there will be preparation for release and guidance for the patient and their families regarding secondary prevention and return to domestic activity. This stage includes mobility, walking, controlled motility and gradual joint activation to maintain ranges and prevent complications from prolonged immobilization in bed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects recruited will be randomized into two groups: one group of subjects (the study group) A physical reminder by a physiotherapist, and a daily reminder of physical exercise by SMS on weekdays A through E. The second group (the control group) will be given a routine training in the ward by a nurse and you will receive a weekly SMS message
| Arm | Type | Receives |
|---|---|---|
| Study group SMS to home phone | Other | Other: Rehabilitation at home via SMSA physical reminder by a physiotherapist, and a daily reminder of physical exercise by SMS on weekdays A through E. |
| Controlled group hospital based | Other | Other: Rehabilitation at home via SMSPhysical rehabilitation in the ward physiotherapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent Criteria for inclusion Patients after acute myocardial infarction admitted to the intensive care unit Patients who speak the Hebrew language Patients with a cell phone to receive a reminder using a message
Key exclusion criteria (3 listed)
- Orthopedic or neurological problem that would prevent physical activity. A score lower than 24 in the MoCA test. High-risk patients.
- Complications: of myocardial infarction congestive heart failure, cardiogenic shock and / or ventricular arrhythmias.
- Angina or shortness of breath at rest. Decrease >1mm in the ST segment in the ECG.
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 |
|---|---|---|
| Rehabilitation at home via SMSAlso: Rehabilitation in hospital settingCardiac rehabilitation | Other | Controlled group hospital based, Study group SMS to home phone |
Primary outcome
Cardiac rehabilitation
Time frame: 1 month
Cardiac rehabilitation following heart attack following discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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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. This study is not recruiting at the moment.
Avraham Shotan, Prof principal investigator
Hillel yaffe MC
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation at home via SMS in people with Acute Myocardial Infarction, run by Hillel Yaffe Medical Center.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alina Roizis (972-4-6304487, Alinaroizis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac rehabilitation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2018.