We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: 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. Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Control Group Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders.
Self-monitoring of pain, stress, and opioid use + alerts/reminders.
Experimental: Experimental Group 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]).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484272


Contacts
Layout table for location contacts
Contact: Victoria Evans 352-273-6323 torifae@ufl.edu

Locations
Layout table for location information
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Miriam Ezenwa, PhD, RN, FAAN         
Sponsors and Collaborators
University of Florida
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Miriam O. Ezenwa University of Florida
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04484272    
Other Study ID Numbers: IRB202000984-N
5R01NR018848-03 ( U.S. NIH Grant/Contract )
PRO00028515 ( Other Identifier: UFIRST )
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents