Implementing, a Mobile Health Application for HIV Infected and Uninfected Women With Co-morbidities in the Outpatient Setting

NCT04810260 | Completed

• 1 other identifier: 2020-12608
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mobile Health; Asthma; Diabetes Mellitus

Keywords

mobile health; asthma; diabetes mellitus

Outcome Measures

Primary Outcomes (6)

• Asthma control measured by the Asthma Control Test.

  Surveys will be applied.

  1 month

• Asthma control measured by the Asthma Control Test.

  Surveys will be applied.

  2 months

• Asthma control measured by the Asthma Control Test.

  Surveys will be applied.

  3 months

• Diabetes quality of life measured by the Diabetes Quality of Life instrument

  Surveys will be applied.

  1 month

• Diabetes quality of life measured by the Diabetes Quality of Life instrument

  Surveys will be applied.

  2 months

• Diabetes quality of life measured by the Diabetes Quality of Life instrument

  Surveys will be applied.

  3 months

Secondary Outcomes (24)

• patient satisfaction regarding the WELLXcel intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS)

  1 month

• patient satisfaction regarding the WELLXcel intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS)

  2 months

• patient satisfaction regarding the WELLXcel intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS)

  3 months

• Unified Theory of Acceptance and Use of Technology questionnaire

  1 months

• Unified Theory of Acceptance and Use of Technology questionnaire

  2 months

Study Arms (2)

HIV +

ACTIVE COMPARATOR

Patients will have the application and use it to increase their awareness about their medical condition.

Behavioral: Use mobile health app (WellXcel) to increase knowledge

HIV -

ACTIVE COMPARATOR

Patients will have the application and use it to increase their awareness about their medical condition.

Behavioral: Use mobile health app (WellXcel) to increase knowledge

Interventions

Use mobile health app (WellXcel) to increase knowledge BEHAVIORAL

Download the app (WellXcel) to the mobile device

HIV +; HIV -

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Biological woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Albert Einstein College Of Medicine/Montefiore MC

The Bronx, New York, 10467, United States

Location

Related Publications (5)

• 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.

  PMID: 22177327 BACKGROUND

• 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.

  PMID: 24524286 BACKGROUND

• 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.

  PMID: 28886173 BACKGROUND

• 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.

  PMID: 28448497 BACKGROUND

• 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.

  PMID: 27244771 BACKGROUND

MeSH Terms

Conditions

Asthma; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sunit Jariwala, MD

  Albert Einstein College of Medicine/Montefiore MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: March 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)