Back to resultsA Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Primary Purpose
Sickle Cell Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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.
Sponsored by
About this trial
This is an interventional supportive care trial for Sickle Cell Disease
Eligibility 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
Sites / Locations
- University of FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
Outcomes
Primary Outcome Measures
Stress intensity scale
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04484272
First Posted
July 21, 2020
Last Updated
September 13, 2022
Sponsor
University of Florida
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04484272
Brief Title
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Official Title
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Title
Experimental Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
Intervention Description
Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring of pain, stress, and opioid use + alerts/reminders.
Intervention Description
Self-monitoring of pain, stress, and opioid use + alerts/reminders.
Primary Outcome Measure Information:
Title
Stress intensity scale
Description
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)
Time Frame
Baseline through Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Evans
Phone
352-273-6323
Email
torifae@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam O. Ezenwa
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Ezenwa, PhD, RN, FAAN
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35904878
Citation
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.
Results Reference
derived
Learn more about this trial
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
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