Implementing, a Mobile Health Application for HIV Infected and Uninfected Women With Co-morbidities in the Outpatient Setting
Condition: Mobile Health; Asthma; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

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.
    

Detailed description: 
      The study objectives and hypotheses are:

      Objective 1. To adapt (including a single platform for multiple chronic conditions) and
      refine WELLXcel for adult women with and without HIV. Hypothesis 1: WELLXcel will be
      associated with a high level of adoption and will be successfully refined based on patient
      feedback. Objective 2. To conduct a pilot study to assess the impact of the adapted and
      refined WELLXcel program on clinical and process outcomes among women with and without HIV.

      Hypothesis 2: WELLXcel will be associated with a high level of patient satisfaction and
      usage, improved asthma and diabetes knowledge, improvements in health quality of life, and
      improved self-reported asthma control and diabetes related quality of life compared to usual
      care. Primary outcomes: Asthma control measured by the Asthma Control Test (ACT) and diabetes
      quality of life measured by the Diabetes Quality of Life (DQOL) instrument.

      Secondary outcomes: Process outcomes - patient satisfaction regarding the WELLXcel
      intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS)
      and the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire; patient
      usage of WELLXcel as determined by Google Analytics (integrated within the WELLXcel app) and
      the WELLXcel backend administrative panel; asthma knowledge (measured by the Asthma Illness
      Representation Scale and diabetes knowledge (measured by the Diabetes Knowledge
      Questionnaire-24)[24] ; diabetes self-management and self-efficacy as measured by the
      Diabetes Self-Management Questionnaire (DSMQ) and Diabetes Empowerment Scale-Short Form
      (DES-SF), respectively. Clinical outcomes - Asthma quality of life measured by the
      Mini-Asthma Quality of Life Questionnaire (mini- AQLQ); asthma and/or diabetes related
      emergency department visits and hospitalizations; and the Patient Health Questionnaire-9
      (PHQ-9) for depression.

      Subjects:

      Inclusion Criteria: English-speaking women >18 years with: (a) 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; (b) able to
      give informed consent; and (c) Smartphone (iOS or Android) access. Exclusion Criteria: (a)
      use of oral corticosteroids in the 2 weeks prior to the baseline visit; (b) pregnancy; (c)
      chronic illness with organ failure (heart failure, severe liver disease, chronic kidney
      disease stage 3-4 or dialysis) or requiring chemotherapy or steroid use; (d) severe
      psychiatric or cognitive problems that would prohibit an individual from understanding and
      completing the protocol; and (e) patients that previously received the ASTHMAXcel
      application.

      Investigators will recruit 30 HIV infected and 30 HIV uninfected adult women with persistent
      asthma and/or Type 2 DM and fulfilling the study's inclusion criteria from the MWCCS cohort.
      At each study site, patients will be prescreened for eligibility using data from WIHS
      (Women's Interagency HIV Study) to identify those who meet the inclusion criteria. In
      adapting with the ongoing COVID-19 pandemic and our existing AHRQ study protocols, patient
      recruitment and study sessions will be conducted virtually to support physical distancing and
      reduce the risk of contracting and transmitting COVID- 19 infection. The study coordinators
      will call potential participants to describe the study and obtain voluntary informed consent
      from interested patients.

      Regarding the consent process, the study participant may choose to complete the e-consent (as
      a form administered through our project's REDCap database via an e-mail link sent to the
      patients who will read and electronically sign the consent) or verbal consent (the consent
      will be read out to the patients who will subsequently provide verbal confirmation of having
      understood the consent text and affirm consenting to the study).

      Voluntary informed consent will include a discussion of the study purpose, study procedures,
      research virtual visit schedule, reimbursement, confidentiality of research records, and
      risks, benefits, and alternatives to study participation. Investigators will discuss that
      research participation is voluntary, and participants will be notified that they can
      discontinue participation at any time.

      The study coordinator will document that the purpose, risks, benefits, and alternative
      treatments were explained to the participant, that the participant agreed to participate in
      this protocol, and the date and time consent was obtained. A copy of the HIPAA form and a
      copy of the informed consent document will be given to the participant. In either case,
      whether the e-consent or the verbal consent form is obtained, the participant will receive
      the consent document, which will be printed and mailed out to them. All informed consent and
      HIPAA documents will be submitted to, and approved by, the Albert Einstein College of
      Medicine IRB. E-consent forms will be stored within our project's secure REDCap database.

      Sixty patients who provide voluntary informed consent will be invited to the remotely
      conducted (via Zoom) baseline visit, which consists of downloading the app to the patient's
      smartphone, explaining the app's functionality, having the patients complete the WELLXcel
      animated educational videos and baseline questionnaires administered by REDCap. Assessments
      will be conducted at baseline followed by 1, 2, and 3 months after baseline. The baseline
      survey and the subsequent assessments will include process outcomes (patient usage,
      acceptance and satisfaction with the app) as well as measures of disease morbidity (asthma
      and diabetes control, utilization measures in terms of asthma and/or diabetes-related ED
      visits and hospitalizations) and quality of life questionnaires. Based on our preliminary
      studies, patients with 1 condition will take approximately 20 minutes to complete the surveys
      during a given study visit. Patients with 2 conditions will take approximately 45 minutes to
      complete the surveys. Each study visit will also include brief semi-structured interviews to
      gather patient feedback (e.g. problems with using the app). Investigators will also use the
      Google Analytics and WELLXcel admin panel to evaluate app usage patterns and click-through
      data to better understand how the app is used, which may lead to the identification of
      additional usability pitfalls. Investigators will use our existing REDCap project database to
      store app-collected data and responses to REDCap-administered questionnaires. At the 2 month
      visit, we will conduct exit interviews with each study participant to enable us to refine the
      app for our upcoming studies.

      To assess digital health literacy and concurrently validate our digital health literacy tool,
      the study baseline session will also include NVS, eHEALS, and our digital health literacy
      tool. At the subsequent 1-month assessment, digital health literacy tool will be
      re-administered to evaluate test-retest reliability. There is no previously defined cut-off
      score on the eHEALS questionnaire which simply defines a patient as eHealth literate' or 'not
      eHealth literate'. For this study, investigators will define literacy as follows: a score of
      32 or higher (out of a 40 point maximum score) will indicate 'good EHL', a score of 24-31
      will indicate 'moderate EHL', and a score below 24 will indicate 'low EHL'. On the objective
      digital health literacy tool, 'good EHL' will be defined as a score from 8-10 (out of a
      maximum of 10), a score of 5-7 will indicate 'moderate EHL', and a score below 5 will
      indicate 'low EHL'. Patients will complete all health literacy questionnaires via REDCAP
      generated e-mail survey links during the study sessions.
    

Intervention name(s): Use mobile health app (WellXcel) to increase knowledge
Intervention type(s): Behavioral
Intervention description(s): Download the app (WellXcel) to the mobile device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: mobile health; asthma; diabetes mellitus