Staying Connected: a Mobile Health Study for Remote Monitoring of Dysphagia Exercises and Patient-reported Outcome Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC
研究概览
简要总结
Mobile health applications are an attractive technological solution that facilitates access to care for patients conveniently and efficiently. Research has shown that remote mHealth delivery has improved patient reported outcomes of disease severity. While such outcomes have traditionally been collected at one point in time within a clinical setting, the potential exists to now gather patient perspectives remotely. Additionally, when combined with a mobile health device, mHealth apps can objectively monitor a treatment plan.
Before implementing a new technology, it is important to investigate how digital health technologies are best integrated into clinical workflows, and how more than one technology can work together to streamline the process. Additionally, it is important to understand the relative benefits of each system from a user perspective and identify how combined data can benefit clinical workflows. Therefore, the purposes of this project are to demonstrate how two technology companies can work together to assess the feasibility of implementing two related systems into one care pathway.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of head and neck cancer;
- •Will be receiving treatment for head and neck cancer (e.g., +/-surgery, +/- radiation therapy, +/- chemotherapy);
- •The primary site of their cancer is the oropharynx, as this is the subgroup of patients known to experience dysphagia.
排除标准
- •Have a history of cognitive delay,
- •History of stroke or traumatic brain injury.
- •Have a beard that they are not willing to shave or partially shave (as the device adheres under the chin, on the surface of the skin).
- •Have an implanted electronic device of any kind, including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and implanted stimulators
- •Have irritated skin or skin with open wounds under the chin;
- •Have an allergy to silver.
结局指标
主要结局
The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC
时间窗: 6 months post-surgery
The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of HNC. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Although no gold standard questionnaire exists for HNC patients, a recent systematic review revealed that MDADI was one of the most frequently utilized and thoroughly tested instruments for symptom-specific HNC measures. While all subscores will be reported for demographic purposes, only the composite score will be used for statistical analyses.
The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health
时间窗: 6 months post-surgery
The Health Questionnaire (EuroQoL EQ-5D) will be administered. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. The 5 areas that it measures include: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients
时间窗: 6 months post-surgery
Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath
Edmonton-33 is a patient reported outcomes measurement scale that was created by patients to measure the main functional areas of concern for patients with head and neck cancer
时间窗: 6 months post-surgery
Edmonton-33 is a patient reported outcomes measurement scale that was created by patients to measure the main functional areas of concern for patients with head and neck cancer.
Patient demographics including age, gender, T-stage, date of surgery
时间窗: pre-operative
Patient demographics including age, gender, T-stage, date of surgery: these variables will be entered into the Noona clinician portal by the research nurse
ER admissions related to aspiration pneumonia or dehydration
时间窗: 6 month post surgery
admissions related to aspiration pneumonia or dehydration: these will be entered into the Noona system by the research nurse, who will access Connect Care at the end of the 6-month period for each patient to record any such events
次要结局
- Top three dysphagia symptoms reported on a weekly basis(Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first)
- Adherence to exercise using Mobili-T system(Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first)
- Targets met when using Mobili-T system(Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first)