Implementing, Validating, and Disseminating a Patient-facing Mobile Health Application for HIV Infected and Uninfected Women With Co-morbid Conditions in the Outpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Asthma control measured by the Asthma Control Test.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Asthma control measured by the Asthma Control Test.
时间窗: 3 months
Surveys will be applied.
Diabetes quality of life measured by the Diabetes Quality of Life instrument
时间窗: 3 months
Surveys will be applied.
次要结局
- patient satisfaction regarding the WELLXcel intervention measured by the validated Questionnaire for User Interface Satisfaction (QUIS)(3 months)
- Asthma quality of life measured by the Mini-Asthma Quality of Life Questionnaire.(3 months)
- Patient Health Questionnaire-9 for depression(3 months)
- Unified Theory of Acceptance and Use of Technology questionnaire(3 months)
- Diabetes self-management and self-efficacy as measured by the Diabetes Self-Management Questionnaire(3 months)
- Patient usage of WELLXcel from the backend administrative panel.(3 months)
- Diabetes Empowerment Scale-Short Form(3 months)
- Asthma and/or diabetes related emergency department visits and hospitalizations(3 months)
研究者
Sunit P. Jariwala
Associate Profesor
Montefiore Medical Center