Asthma Clinical Trial
Official title:
Implementing, Validating, and Disseminating a Patient-facing Mobile Health Application for HIV Infected and Uninfected Women With Co-morbid Conditions in the Outpatient Setting
NCT number | NCT04810260 |
Other study ID # | 2020-12608 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | July 1, 2023 |
Verified date | October 2023 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pilot study conducted at the Bronx MWCCS Clinical Research Site in the Bronx, NY. We will recruit 60 individuals with coexisting asthma and/or Type 2 DM from this cohort. During the 3 month study period, these 60 participants will receive a comprehensive mobile health (mHealth) app, WELLXcel which includes: 1) guideline-based asthma and diabetes education delivered through interactive features such as animated videos and tailored push notifications; 2) the collection of PRO measures to enable patients symptom self-tracking. During this study, we will evaluate the association between baseline digital health literacy and favorable clinical outcomes related to the WELLXcel study intervention.
Status | Completed |
Enrollment | 42 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: English-speaking women >18 years with: - persistent asthma (diagnosis via self-report) on a daily controller medication and/or Type 2 diabetes mellitus (diagnosis via self-report) on at least one oral hypoglycemic medication and/or Insulin; - able to give informed consent; - Smartphone (iOS or Android) access. Exclusion Criteria: - use of oral corticosteroids in the 2 weeks prior to the baseline visit; - pregnancy - chronic illness with organ failure (heart failure, severe liver disease, chronic kidney disease stage 3-4 or dialysis) or requiring chemotherapy or steroid use; - severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol; - patients that previously received the ASTHMAXcel application. |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein College Of Medicine/Montefiore MC | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Gingo MR, Wenzel SE, Steele C, Kessinger CJ, Lucht L, Lawther T, Busch M, Hillenbrand ME, Weinman R, Slivka WA, McMahon DK, Zhang Y, Sciurba FC, Morris A. Asthma diagnosis and airway bronchodilator response in HIV-infected patients. J Allergy Clin Immunol. 2012 Mar;129(3):708-714.e8. doi: 10.1016/j.jaci.2011.11.015. Epub 2011 Dec 15. — View Citation
Kendall CE, Wong J, Taljaard M, Glazier RH, Hogg W, Younger J, Manuel DG. A cross-sectional, population-based study measuring comorbidity among people living with HIV in Ontario. BMC Public Health. 2014 Feb 13;14:161. doi: 10.1186/1471-2458-14-161. — View Citation
Nguyen J, Moorhouse M, Curbow B, Christie J, Walsh-Childers K, Islam S. Construct Validity of the eHealth Literacy Scale (eHEALS) Among Two Adult Populations: A Rasch Analysis. JMIR Public Health Surveill. 2016 May 20;2(1):e24. doi: 10.2196/publichealth.4967. — View Citation
Petoumenos K, Huang R, Hoy J, Bloch M, Templeton DJ, Baker D, Giles M, Law MG, Cooper DA. Prevalence of self-reported comorbidities in HIV positive and HIV negative men who have sex with men over 55 years-The Australian Positive & Peers Longevity Evaluation Study (APPLES). PLoS One. 2017 Sep 8;12(9):e0184583. doi: 10.1371/journal.pone.0184583. eCollection 2017. — View Citation
Richtering SS, Morris R, Soh SE, Barker A, Bampi F, Neubeck L, Coorey G, Mulley J, Chalmers J, Usherwood T, Peiris D, Chow CK, Redfern J. Examination of an eHealth literacy scale and a health literacy scale in a population with moderate to high cardiovascular risk: Rasch analyses. PLoS One. 2017 Apr 27;12(4):e0175372. doi: 10.1371/journal.pone.0175372. eCollection 2017. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asthma control measured by the Asthma Control Test. | Surveys will be applied. | 1 month | |
Primary | Asthma control measured by the Asthma Control Test. | Surveys will be applied. | 2 months | |
Primary | Asthma control measured by the Asthma Control Test. | Surveys will be applied. | 3 months | |
Primary | Diabetes quality of life measured by the Diabetes Quality of Life instrument | Surveys will be applied. | 1 month | |
Primary | Diabetes quality of life measured by the Diabetes Quality of Life instrument | Surveys will be applied. | 2 months | |
Primary | Diabetes quality of life measured by the Diabetes Quality of Life instrument | Surveys will be applied. | 3 months | |
Secondary | patient satisfaction regarding the WELLXcel intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS) | Surveys will be applied | 1 month | |
Secondary | patient satisfaction regarding the WELLXcel intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS) | Surveys will be applied | 2 months | |
Secondary | patient satisfaction regarding the WELLXcel intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS) | Surveys will be applied | 3 months | |
Secondary | Unified Theory of Acceptance and Use of Technology questionnaire | Surveys will be applied | 1 months | |
Secondary | Unified Theory of Acceptance and Use of Technology questionnaire | Surveys will be applied | 2 months | |
Secondary | Unified Theory of Acceptance and Use of Technology questionnaire | Surveys will be applied | 3 months | |
Secondary | Patient usage of WELLXcel from the backend administrative panel. | Analyse the administrative panel. | 1 month | |
Secondary | Patient usage of WELLXcel from the backend administrative panel. | Analyse the administrative panel. | 2 months | |
Secondary | Patient usage of WELLXcel from the backend administrative panel. | Analyse the administrative panel. | 3 months | |
Secondary | Diabetes self-management and self-efficacy as measured by the Diabetes Self-Management Questionnaire | Surveys will be applied | 1 months | |
Secondary | Diabetes self-management and self-efficacy as measured by the Diabetes Self-Management Questionnaire | Surveys will be applied | 2 months | |
Secondary | Diabetes self-management and self-efficacy as measured by the Diabetes Self-Management Questionnaire | Surveys will be applied | 3 months | |
Secondary | Diabetes Empowerment Scale-Short Form | Surveys will be applied | 1 months | |
Secondary | Diabetes Empowerment Scale-Short Form | Surveys will be applied | 2 months | |
Secondary | Diabetes Empowerment Scale-Short Form | Surveys will be applied | 3 months | |
Secondary | Asthma quality of life measured by the Mini-Asthma Quality of Life Questionnaire. | Surveys will be applied | 1 months | |
Secondary | Asthma quality of life measured by the Mini-Asthma Quality of Life Questionnaire. | Surveys will be applied | 2 months | |
Secondary | Asthma quality of life measured by the Mini-Asthma Quality of Life Questionnaire. | Surveys will be applied | 3 months | |
Secondary | Asthma and/or diabetes related emergency department visits and hospitalizations | Patient reports will be used. | 1 month | |
Secondary | Asthma and/or diabetes related emergency department visits and hospitalizations | Patient reports will be used. | 2 months | |
Secondary | Asthma and/or diabetes related emergency department visits and hospitalizations | Patient reports will be used. | 3 months | |
Secondary | Patient Health Questionnaire-9 for depression | Surveys will be applied | 1 month | |
Secondary | Patient Health Questionnaire-9 for depression | Surveys will be applied | 2 months | |
Secondary | Patient Health Questionnaire-9 for depression | Surveys will be applied | 3 months |
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