Use of a Mobile-based App for SCD Patients (SMART)
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| ClinicalTrials.gov Identifier: NCT01833702 |
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Recruitment Status :
Completed
First Posted : April 17, 2013
Last Update Posted : July 16, 2019
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Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
| Tracking Information | ||||||||||
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| First Submitted Date | April 13, 2013 | |||||||||
| First Posted Date | April 17, 2013 | |||||||||
| Last Update Posted Date | July 16, 2019 | |||||||||
| Actual Study Start Date | June 2012 | |||||||||
| Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Usability [ Time Frame: 42 days ] Patients are able to use a mobile device to record daily symptoms, including pain, and interventions, including medication administration.
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Use of a Mobile-based App for SCD Patients | |||||||||
| Official Title | Use of a Mobile-based Pain Assessment Application for SCD Patients | |||||||||
| Brief Summary | The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily. The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system. |
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| Detailed Description | The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system. The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily. Patients enrolled in this study will be ask to use a mobile device such as a smartphone or a tablet with Android or iOS operating system to record daily pain level and related information once daily or more frequently for a period of forty-two days. A 1:1 randomization assignment will be made to have patients receive automated "canned" provider feedback or not. | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Patients experiencing pain or patients with sickle cell disease | |||||||||
| Condition |
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| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
21 | |||||||||
| Original Estimated Enrollment |
100 | |||||||||
| Actual Study Completion Date | May 2014 | |||||||||
| Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 12 Years to 100 Years (Child, Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01833702 | |||||||||
| Other Study ID Numbers | Pro00037857 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | Duke University | |||||||||
| Original Responsible Party | Jude C. Jonassaint, Duke University, RN | |||||||||
| Current Study Sponsor | Duke University | |||||||||
| Original Study Sponsor | Jude C. Jonassaint | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Duke University | |||||||||
| Verification Date | November 2018 | |||||||||