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出境医 / 临床实验 / Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease (RESILIENT)

Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease (RESILIENT)

Study Description
Brief Summary:
RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Other: mHealth-CR Not Applicable

Detailed Description:
The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age ≥65) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: partial mask (outcomes assessor)
Primary Purpose: Treatment
Official Title: REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : April 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: mHealth-CR Other: mHealth-CR
Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device.
No Intervention: Usual Care
Outcome Measures
Primary Outcome Measures :
  1. Change in 6-minute walking distance (6MWD) [ Time Frame: 3 month ]
    Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6-minute walk test (6MWT) is a submaximal exercise test in which the pace is self-selected by the participant. The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse.


Secondary Outcome Measures :
  1. Goal Attainment measured using a 5-point goal attainment scale (GAS) [ Time Frame: 3 month ]
    Using the SMART goal framework, GAS describes the person's expected level of goal achievement over 3 months, ranging from no change (scored as -2) to much better than expected (scored as +2) out of a 5 point-scale. Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. Overall score is calculated by incorporating the goal of outcomes scores into an aggregated t-score. Goal attainment, through goal setting, is an especially important outcome in older adults who may begin an intervention with a variety of deficits (therefore necessitating individualized therapy towards realistic goals).

  2. Participant reported health status - measured using the SF-12 [ Time Frame: 3 month ]
    Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). For the SF-12, we will analyze change from baseline to 3 months using a threshold of 5 points in SF-12 physical component score (PCS) as a clinically meaningful change

  3. Participant reported health status - measured Seattle Angina Questionnaire 7 (SAQ-7) (disease-specific health status). [ Time Frame: 3 month ]
    Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). For SAQ-7, we will analyze at a single time point (3 months) the number of participants who have residual angina (SAQ-7<100) vs. no angina (SAQ-7=100).

  4. Change in Basic Activities of Daily Living (BADLs) [ Time Frame: 3 month ]
    defined as any improvement or worsening in basic (BADLs) over 3 months. BADLs are basic self-care behaviors: feeding, toileting, bathing, dressing, and ambulating. I

  5. Change in Activities of Daily Living (ADLs) [ Time Frame: 3 months. ]
    defined as any improvement or worsening in instrumental (IADLs) activities of daily living over 3 months. ADLs are activities that allow a person to live independently (e.g. food preparation, medication management, transportation, shopping, managing finances, using the telephone, and housekeeping).

  6. Hospital readmissions evaluated at 3, 6 and 12 Months [ Time Frame: 1 Year ]
    Defined as number of participants who were readmitted into the hospital with an overnight stay (including observation) in any hospital within 3, 6, and 12 months of hospitalization. Data are obtainable via the electronic health record (EHR).

  7. Death [ Time Frame: 1 Year ]
    is defined by number of participants who died from any cause within 3, 6, and 12 months of enrollment. Data are obtainable via the electronic health record (EHR).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years to 110 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥65
  2. Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks.
  3. Capable of self-consent.
  4. Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).

Exclusion Criteria:

  1. Non-ambulatory.
  2. Moderate or severe cognitive impairment.
  3. Unable/unwilling to consent.
  4. PCI-related groin hematoma that precludes brisk walking.
  5. Incarcerated.
  6. Unable to use mHealth software in English or Spanish.
  7. Severe osteoarthritis, or joint replacement within last 3 months.
  8. Parkinson's disease or other progressive movement disorder.
  9. Regular use of walker for ambulation.
  10. Projected life expectancy <3 months.
  11. Clinical judgment concerning other safety or nonadherence issues.
  12. Participants admitted from long-term care facility.
  13. Currently listed for heart transplant.
  14. Left ventricular assist device recipient.
  15. Completion of ambulatory cardiac rehabilitation program within prior 3 months.
Contacts and Locations

Contacts
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Contact: Ana Fonceva (646) 939-5791 resilient@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Ana Fonceva    646-939-5791    resilient@nyulangone.org   
Principal Investigator: John Dodson, MD         
Sponsors and Collaborators
NYU Langone Health
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: John Dodson, MD New York Langone Health
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE January 9, 2020
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2019) 		Change in 6-minute walking distance (6MWD) [ Time Frame: 3 month ]
Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6-minute walk test (6MWT) is a submaximal exercise test in which the pace is self-selected by the participant. The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse.
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Change in the 6MWD between Baseline and 3 Month Follow Up [ Time Frame: 3 Months ]
Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2019)
  • Goal Attainment measured using a 5-point goal attainment scale (GAS) [ Time Frame: 3 month ]
    Using the SMART goal framework, GAS describes the person's expected level of goal achievement over 3 months, ranging from no change (scored as -2) to much better than expected (scored as +2) out of a 5 point-scale. Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. Overall score is calculated by incorporating the goal of outcomes scores into an aggregated t-score. Goal attainment, through goal setting, is an especially important outcome in older adults who may begin an intervention with a variety of deficits (therefore necessitating individualized therapy towards realistic goals).
  • Participant reported health status - measured using the SF-12 [ Time Frame: 3 month ]
    Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). For the SF-12, we will analyze change from baseline to 3 months using a threshold of 5 points in SF-12 physical component score (PCS) as a clinically meaningful change
  • Participant reported health status - measured Seattle Angina Questionnaire 7 (SAQ-7) (disease-specific health status). [ Time Frame: 3 month ]
    Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). For SAQ-7, we will analyze at a single time point (3 months) the number of participants who have residual angina (SAQ-7<100) vs. no angina (SAQ-7=100).
  • Change in Basic Activities of Daily Living (BADLs) [ Time Frame: 3 month ]
    defined as any improvement or worsening in basic (BADLs) over 3 months. BADLs are basic self-care behaviors: feeding, toileting, bathing, dressing, and ambulating. I
  • Change in Activities of Daily Living (ADLs) [ Time Frame: 3 months. ]
    defined as any improvement or worsening in instrumental (IADLs) activities of daily living over 3 months. ADLs are activities that allow a person to live independently (e.g. food preparation, medication management, transportation, shopping, managing finances, using the telephone, and housekeeping).
  • Hospital readmissions evaluated at 3, 6 and 12 Months [ Time Frame: 1 Year ]
    Defined as number of participants who were readmitted into the hospital with an overnight stay (including observation) in any hospital within 3, 6, and 12 months of hospitalization. Data are obtainable via the electronic health record (EHR).
  • Death [ Time Frame: 1 Year ]
    is defined by number of participants who died from any cause within 3, 6, and 12 months of enrollment. Data are obtainable via the electronic health record (EHR).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Goal Attainment as measured by goal attainment scaling (GAS) [ Time Frame: 3 Months ]
defined as whether a person's individual functional goals are achieved as a result of the study intervention, measured using a 5-point goal attainment scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease
Official Title  ICMJE REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
Brief Summary RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.
Detailed Description The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age ≥65) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
partial mask (outcomes assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE Other: mHealth-CR
Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device.
Study Arms  ICMJE
  • Experimental: mHealth-CR
    Intervention: Other: mHealth-CR
  • No Intervention: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2019) 		400
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		300
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥65
  2. Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks.
  3. Capable of self-consent.
  4. Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).

Exclusion Criteria:

  1. Non-ambulatory.
  2. Moderate or severe cognitive impairment.
  3. Unable/unwilling to consent.
  4. PCI-related groin hematoma that precludes brisk walking.
  5. Incarcerated.
  6. Unable to use mHealth software in English or Spanish.
  7. Severe osteoarthritis, or joint replacement within last 3 months.
  8. Parkinson's disease or other progressive movement disorder.
  9. Regular use of walker for ambulation.
  10. Projected life expectancy <3 months.
  11. Clinical judgment concerning other safety or nonadherence issues.
  12. Participants admitted from long-term care facility.
  13. Currently listed for heart transplant.
  14. Left ventricular assist device recipient.
  15. Completion of ambulatory cardiac rehabilitation program within prior 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 110 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ana Fonceva (646) 939-5791 resilient@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978130
Other Study ID Numbers  ICMJE 18-02017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: Requests should be directed to john.dodson@nyumc.org. To gain access, data requestors will need to sign a data access agreement. The investigator who proposed to use the data.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: John Dodson, MD New York Langone Health
PRS Account NYU Langone Health
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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