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出境医 / 临床实验 / Sustaining Physical Activity Following Cardiac Rehabilitation Completion

Sustaining Physical Activity Following Cardiac Rehabilitation Completion

Study Description
Brief Summary:
Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use.

Condition or disease Intervention/treatment Phase
Cardiac Rehabilitation Behavioral: Activity Tracker Not Applicable

Detailed Description:
Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use. Each week they will be provided a summary report of their steps and physical activity, that will continue to 6 weeks post discharge from cardiac rehabilitation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study. All participants receive the intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sustaining Physical Activity Following Cardiac Rehabilitation Completion
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Activity Tracker
Participants provided an activity tracker to wear and weekly reports
 Behavioral: Activity Tracker
Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge.
Other Name: Fitbit
Outcome Measures
Primary Outcome Measures :
  1. Average Steps Per Day (Preintervention Period) [ Time Frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks ]
    Average steps per day measured by the activity tracker

  2. Average Physical Activity in Minutes Per Day (Preintervention Period) [ Time Frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks ]
    Average "very active" minutes per day of physical activity measured by the activity tracker

  3. Average Steps Per Day (Intervention Period) [ Time Frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks ]
    Average steps per day measured by the activity tracker

  4. Average Physical Activity in Minutes Per Day (Intervention Period) [ Time Frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks ]
    Average "very active" minutes per day of physical activity measured by the activity tracker

  5. Average Steps Per Day (Maintenance Period) [ Time Frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks ]
    Average steps per day measured by the activity tracker

  6. Average Physical Activity Per Day (Maintenance Period) [ Time Frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks ]
    Average "very active" minutes per day of physical activity measured by the activity tracker


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • coronary heart disease
  • currently attending cardiac rehabilitation with at least 4 weeks left
  • >=18 years of age
  • own a smart phone and able to participate in mobile health program
  • able to understand and write English
  • adequate clinical stability
  • understand and sign informed consent

Exclusion criteria:

  • currently using a digital physical activity tracker
  • past use of a digital activity tracker
  • planning to relocate in 12 weeks
  • acute coronary artery disease symptoms
  • decompensated heart failure
  • New York Heart Association class IV heart failure
  • severe valvular heart disease
  • severe pulmonary hypertension
  • cardiac transplantation
  • visually impaired, severe
  • end stage renal disease
  • impairment from stroke, injury, or other medical disorder that precludes participation
  • dementia that precludes ability to participate and follow protocol
  • inability or unwillingness to comply with study requirements
Contacts and Locations

Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kelly Evenson, PhD University of North Carolina, Chapel Hill
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Results First Submitted Date  ICMJE June 26, 2019
Results First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE November 13, 2017
Actual Primary Completion Date March 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Average Steps Per Day (Preintervention Period) [ Time Frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks ]
    Average steps per day measured by the activity tracker
  • Average Physical Activity in Minutes Per Day (Preintervention Period) [ Time Frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks ]
    Average "very active" minutes per day of physical activity measured by the activity tracker
  • Average Steps Per Day (Intervention Period) [ Time Frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks ]
    Average steps per day measured by the activity tracker
  • Average Physical Activity in Minutes Per Day (Intervention Period) [ Time Frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks ]
    Average "very active" minutes per day of physical activity measured by the activity tracker
  • Average Steps Per Day (Maintenance Period) [ Time Frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks ]
    Average steps per day measured by the activity tracker
  • Average Physical Activity Per Day (Maintenance Period) [ Time Frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks ]
    Average "very active" minutes per day of physical activity measured by the activity tracker
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Average Steps Per Day (Preintervention Period) [ Time Frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks ]
    Average steps per day measured by the activity tracker
  • Average Physical Activity in Minutes Per Day (Preintervention Period) [ Time Frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks ]
    Average physical activity in minutes per day measured by the activity tracker
  • Average Steps Per Day (Intervention Period) [ Time Frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks ]
    Average steps per day measured by the activity tracker
  • Average Physical Activity in Minutes Per Day (Intervention Period) [ Time Frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks ]
    Average physical activity in minutes per day measured by the activity tracker
  • Average Steps Per Day (Maintenance Period) [ Time Frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks ]
    Average steps per day measured by the activity tracker
  • Average Physical Activity Per Day (Maintenance Period) [ Time Frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks ]
    Average physical activity in minutes per day measured by the activity tracker
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sustaining Physical Activity Following Cardiac Rehabilitation Completion
Official Title  ICMJE Sustaining Physical Activity Following Cardiac Rehabilitation Completion
Brief Summary Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use.
Detailed Description Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use. Each week they will be provided a summary report of their steps and physical activity, that will continue to 6 weeks post discharge from cardiac rehabilitation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a pilot study. All participants receive the intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cardiac Rehabilitation
Intervention  ICMJE Behavioral: Activity Tracker
Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge.
Other Name: Fitbit
Study Arms  ICMJE Experimental: Activity Tracker
Participants provided an activity tracker to wear and weekly reports
Intervention: Behavioral: Activity Tracker
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2019) 		5
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 21, 2018
Actual Primary Completion Date March 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • coronary heart disease
  • currently attending cardiac rehabilitation with at least 4 weeks left
  • >=18 years of age
  • own a smart phone and able to participate in mobile health program
  • able to understand and write English
  • adequate clinical stability
  • understand and sign informed consent

Exclusion criteria:

  • currently using a digital physical activity tracker
  • past use of a digital activity tracker
  • planning to relocate in 12 weeks
  • acute coronary artery disease symptoms
  • decompensated heart failure
  • New York Heart Association class IV heart failure
  • severe valvular heart disease
  • severe pulmonary hypertension
  • cardiac transplantation
  • visually impaired, severe
  • end stage renal disease
  • impairment from stroke, injury, or other medical disorder that precludes participation
  • dementia that precludes ability to participate and follow protocol
  • inability or unwillingness to comply with study requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991715
Other Study ID Numbers  ICMJE 16-3306
UL1TR001111 ( U.S. NIH Grant/Contract )
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: No
Plan Description:

Time Frame: Deidentified individual data that supports the activity tracker results may be shared from 0-12 months following publication.

Access Criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Kelly Evenson, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2019

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

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