Acute Myocardial Infarction (AMI)RESILIENTNCT02804906
Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
A study testing Home-based physical therapy in people with Acute Myocardial Infarction (AMI), run by NYU Langone Health at 1 site in United States.
Trial summary
This pilot feasibility study will test whether a home-based cardiac rehabilitation intervention, using physical therapist visits combined with mobile health technology, will prevent decline in high-risk patients post acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Home-based physical therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 14 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Clinical diagnosis of acute myocardial infarction (AMI).
Who cannot join
- moderate to severe cognitive impairment; non-ambulatory
- severe heart failure (NYHA Class IV); decisional impairment as assessed by the University of California
- San Diego Brief Assessment of Capacity to Consent (UBACC) 22, if the RC questions capacity; very limited life expectancy (e.g. anticipated discharge to hospice)
- non-English/non-Spanish speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This pilot feasibility study will test whether a home-based cardiac rehabilitation intervention, using physical therapist visits combined with mobile health technology, will prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants will be randomized to either an intervention arm (home-based physical therapy), or a control (usual care) arm. Prior to discharge, participants in the intervention arm will receive a 1-hour educational session by a research physical therapist that includes information on cardiac risk factor management, postoperative recovery, education on medication adherence, and a prescription for home exercise that is tailored to each patient's baseline abilities and limitations. Participants assigned to the control arm will receive a 30-minute counseling session on risk factor modification prior to discharge, in addition to usual care post-AMI.
Read the detailed description
All participants enrolled in this research study will receive the FDA-approved FitBit Flex, a wearable activity monitoring device which will objectively measure physical activity and sedentary behavior in the period post-hospital discharge. Daily activity monitoring will include: number of steps, distance traveled, calories burned, number of active minutes.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Home-based physical therapy, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based physical therapyBehavioural
Participants will be visited by a physical therapist 3 times a week for approximately 1 hour each day, for a duration of 4 weeks. These visits will serve to encourage adherence to the intervention, reinforce activities recommended at discharge, monitor safety under direct supervision, and adjust the exercise prescription if/as needed (e.g. advance recommended activity level) if necessary. Patients will also be provided with a tablet computer device installed with software, Moving Analytics, that will reinforce the cardiac rehabilitation program through daily reminders and easily accessible visual activity plans. This program will be updated by the physical therapist during home visits as the program advances. Daily patient-reported health status ("Your Activities of Daily Living") 26 will be ascertained on the same tablet device by participants three times per week using open source software designed.
Usual CareBehavioural
Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge. Participants will be provided with a tablet computer device to complete patient-reported health status ("Your Activities of Daily Living") 26 three times per week using open source software designed. Participants will be visited by the Research Coordinator or member of the study team at one month post-hospital discharge to perform a follow-up assessment that will include ADLs, IADLs, SF-12 PCS, frailty measures, and questions on healthcare utilization (hospital readmissions).
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Physical Therapy | Experimental | Not described Receives: Behavioral: Home-based physical therapy |
| Control-30-minute counseling session | Active comparator | Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of Daily Living (ADL) Decline
Assessment of the functional dependence or independence in carrying out activities of daily living, including bathing, dressing, toileting, transferring, continence, and feeding.
Measured: 5 Weeks
Secondary outcomes (4)
Decline in self-perceived physical health (measured by SF-12 PCS)
Health status measure that addresses both physical and mental health.
Measured: 5 Weeks
Mean time spent in sedentary activity
Measured: 5 Weeks
Mortality Rate
Measured: 5 Weeks
Hospital readmission rate
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion14 Dec 2018
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Dodson, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804906
- Sponsor's protocol ID
- 16-00554
- Acronym
- RESILIENT
- Status last verified
- Jan 2020
- First submitted
- 14 Jun 2016
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02804906
- Acronym / sponsor ID
- RESILIENT / 16-00554
- Conditions
- Acute Myocardial Infarction (AMI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
This pilot feasibility study will test whether a home-based cardiac rehabilitation intervention, using physical therapist visits combined with mobile health technology, will prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants will be randomized to either an intervention arm (home-based physical therapy), or a control (usual care) arm. Prior to discharge, participants in the intervention arm will receive a 1-hour educational session by a research physical therapist that includes information on cardiac risk factor management, postoperative recovery, education on medication adherence, and a prescription for home exercise that is tailored to each patient's baseline abilities and limitations. Participants assigned to the control arm will receive a 30-minute counseling session on risk factor modification prior to discharge, in addition to usual care post-AMI.
Detailed description
All participants enrolled in this research study will receive the FDA-approved FitBit Flex, a wearable activity monitoring device which will objectively measure physical activity and sedentary behavior in the period post-hospital discharge. Daily activity monitoring will include: number of steps, distance traveled, calories burned, number of active minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-Based Physical Therapy | Experimental | Behavioral: Home-based physical therapy |
| Control-30-minute counseling session | Active comparator | Behavioral: Usual CareParticipants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute myocardial infarction (AMI).
Key exclusion criteria (4 listed)
- moderate to severe cognitive impairment; non-ambulatory
- severe heart failure (NYHA Class IV); decisional impairment as assessed by the University of California
- San Diego Brief Assessment of Capacity to Consent (UBACC) 22, if the RC questions capacity; very limited life expectancy (e.g. anticipated discharge to hospice)
- non-English/non-Spanish speaking.
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 physical therapyParticipants will be visited by a physical therapist 3 times a week for approximately 1 hour each day, for a duration of 4 weeks. These visits will serve to encourage adherence to the intervention, reinforce activities recommended at discharge, monitor safety under direct supervision, and adjust the exercise prescription if/as needed (e.g. advance recommended activity level) if necessary. Patients will also be provided with a tablet computer device installed with software, Moving Analytics, that will reinforce the cardiac rehabilitation program through daily reminders and easily accessible visual activity plans. This program will be updated by the physical therapist during home visits as the program advances. Daily patient-reported health status ("Your Activities of Daily Living") 26 will be ascertained on the same tablet device by participants three times per week using open source software designed. | Behavioural | Home-Based Physical Therapy |
| Usual CareParticipants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge. Participants will be provided with a tablet computer device to complete patient-reported health status ("Your Activities of Daily Living") 26 three times per week using open source software designed. Participants will be visited by the Research Coordinator or member of the study team at one month post-hospital discharge to perform a follow-up assessment that will include ADLs, IADLs, SF-12 PCS, frailty measures, and questions on healthcare utilization (hospital readmissions). | Behavioural | Control-30-minute counseling session |
Primary outcome
Activities of Daily Living (ADL) Decline
Time frame: 5 Weeks
Assessment of the functional dependence or independence in carrying out activities of daily living, including bathing, dressing, toileting, transferring, continence, and feeding.
4 secondary outcomes
Decline in self-perceived physical health (measured by SF-12 PCS)
Time frame: 5 Weeks
Mean time spent in sedentary activity
Time frame: 5 Weeks
Mortality Rate
Time frame: 5 Weeks
Hospital readmission rate
Time frame: 5 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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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.
John Dodson, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based physical therapy in people with Acute Myocardial Infarction (AMI), run by NYU Langone Health at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of Daily Living (ADL) Decline (time frame: 5 Weeks). 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 22 Jan 2020.