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A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484272
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : September 14, 2022
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE July 21, 2020
First Posted Date  ICMJE July 23, 2020
Last Update Posted Date September 14, 2022
Actual Study Start Date  ICMJE April 29, 2021
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2020)		 Stress intensity scale [ Time Frame: Baseline through Week 8 ]
This 3-item scale asks patients to report their current, least, and worst stress intensity in the past 24 hours, on a scale of 0 (no stress) to 10 (stress as bad as it could be)
Original Primary Outcome Measures  ICMJE Same as current
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 A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Official Title  ICMJE A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Brief Summary The long-term goal is to reduce stress and improve pain control with less opioid use in patients with sickle cell disease by promoting an intervention with self-management relaxation/distraction exercises, named You Cope, We Support (YCWS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
    Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
  • Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders.
    Self-monitoring of pain, stress, and opioid use + alerts/reminders.
Study Arms  ICMJE
  • Active Comparator: Control Group
    Intervention: Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders.
  • Experimental: Experimental Group
    Intervention: Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
Publications * Ezenwa MO, Yao Y, Mandernach MW, Fedele DA, Lucero RJ, Corless I, Dyal BW, Belkin MH, Rohatgi A, Wilkie DJ. A Stress and Pain Self-management mHealth App for Adult Outpatients With Sickle Cell Disease: Protocol for a Randomized Controlled Study. JMIR Res Protoc. 2022 Jul 29;11(7):e33818. doi: 10.2196/33818.

*   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 22, 2020)		 185
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • with diagnosis of SCD (e.g., HbSS, HbSC, HbS-beta-0 thalassemia, and HbS-beta+ thalassemia); (b) reports moderate to severe level of pain (>3 on 0-10 scale) related to SCD within previous 24 hours; (c) uses opioid analgesics on "as needed" or "continuous" basis (d) who speaks and reads English; and (e) is 18 years of age or older

Exclusion Criteria:

  • are legally blind; (b) physically unable to complete procedures; (c) previously participated in our relaxation/distraction intervention feasibility study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Victoria Evans 352-273-6323 torifae@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04484272
Other Study ID Numbers  ICMJE IRB202000984-N
5R01NR018848-03 ( U.S. NIH Grant/Contract )
PRO00028515 ( Other Identifier: UFIRST )
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
Current Responsible Party University of Florida
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Miriam O. Ezenwa University of Florida
PRS Account University of Florida
Verification Date September 2022

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