跳至主要内容
临床试验/NCT04698499
NCT04698499已完成不适用

Swallowing Therapy With the Assistance of a Mobile Health Device in Head and Neck Cancer Patients: a Pan-Alberta Study

University of Alberta1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Percent adherence to recommended number of exercises

研究概览

简要总结

Dysphagia affects 22% of those over the age of 50, which equates to 250 million people worldwide and 360,000 in Alberta. At high risk are survivors of head and neck cancer (70%). Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. To regain swallowing function and avoid or reduce the consequences of dysphagia, patients require regular, intensive therapy over many months to strengthen swallowing muscles and improve swallow coordination. This therapy is often coupled with visual biofeedback that uses surface electromyography (sEMG). Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it.

The primary aim of this work is to determine whether the use of a mobile system equipped with sEMG biofeedback affects adherence to home-based swallowing exercises. The secondary aim of this work is to determine if the exercise program results in improved patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous findings of adherence can be replicated.

Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment will be enrolled in the study. This study will follow a cross over randomized design such that all participants will be provided with both types of treatment: using pen and paper (Treatment Arm A) and using the mobile health system (Treatment Arm B).

详细描述

Background Dysphagia affects 22% of those over the age of 50 [1], which equates to 250 million people worldwide and 360,000 in Alberta [2]. At high risk are survivors of head and neck cancer (70%), stroke patients (78%), people with Parkinson's disease (82%) and those who've had a traumatic brain injury (65%) [3]. Left untreated, dysphagia has serious health consequences, such as malnutrition, aspiration pneumonia, and even death. The associated longer hospital stays and complications result in an estimated annual burden of care of $547 billion in USA [4]. In Alberta, managing just one consequence of dysphagia (aspiration pneumonia) in patients with head and neck cancer and stroke costs the healthcare system $2.53 million CAD a year [5]. Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. Patients with dysphagia avoid social situations that involve eating, are disproportionately affected by depression, and miss more than 3 times the number of workdays than individuals without swallowing difficulties.

To regain swallowing function and avoid or reduce the aforementioned consequences of dysphagia, patients require regular, intensive therapy over many months to strengthen swallowing muscles and improve swallow coordination. This therapy is often coupled with visual biofeedback that uses surface electromyography (sEMG). sEMG biofeedback lets patients know how hard their muscles are contracting and for how long during a given exercise. sEMG biofeedback is used to teach patients how to perform exercises correctly, elicit maximum effort, and demonstrate incremental improvements in performance.

Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it. This limited access stems from poor patient and clinician resources. For patients, getting to the clinic to access a clinician and the equipment is inconvenient and costly. In order to cope with limited patient engagement, clinicians are more likely to manage dysphagia by providing diet modifications, by prescribing feeding tubes, and by giving patients maneuvers and exercises on a printed sheet of paper. These approaches to the management of dysphagia are inadequate to meet the needs of patients. Furthermore, a recent systematic review found that average adherence to dysphagia management recommendations was between 22% and 52% [6]. With the advent of strict distancing restrictions during the COVID-19 pandemic, remote care via telerehabilitation or mobile health (mHealth) technologies has received increased attention.

AIMS: The primary aim of this work is to determine whether the use of a mobile system equipped with sEMG biofeedback affects adherence to home-based swallowing exercises.

The secondary aim of this work is to determine if the exercise program results in improved patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous findings of adherence can be replicated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • prior diagnosis of oropharyngeal dysphagia secondary to treatment for squamous cell carcinoma (OPSCC)
  • 3 months or later post-surgery or post-(chemo)radiation therapy
  • received treatment for head and neck cancer (e.g., +/-surgery, +/-radiation therapy, +/- chemotherapy)
  • attending speech-language pathologist has confirmed from a Modified Barium Swallow (MBS) assessment or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) that the patient is a candidate for the effortful swallow and/or the Mendelsohn maneuver therapy.

排除标准

  • have a history of cognitive delay (patient or SLP reported)
  • have a history of stroke or traumatic brain injury (patient or SLP reported)
  • cannot reliably navigate the Mobili-T system after the training session
  • attending SLP confirms planned swallowing exercises or procedures to address dysphagia like esophageal dilation
  • 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
  • have a beard or not willing to shave or partially shave
  • unable to travel to Edmonton 3 times during a 3 month period

结局指标

主要结局

Percent adherence to recommended number of exercises

时间窗: The duration of the trial, up to approximately 13 weeks

Daily adherence logs will be collected via diary forms completed using pen and paper for Treatment Arm A. For Treatment Arm B, daily adherence logs will be collected remotely, by the Mobili-T system Adherence can range from 0% (no adherence) to 100% (best adherence).

Change in the MD Anderson Dysphagia Inventory (MDADI)

时间窗: 13 weeks post-baseline

Patient questionnaire The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of head and neck cancer. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Scores are summed, and a mean score is calculated. This mean score is multiplied by 20 to obtain a score with a range of 0 (extremely low functioning) to 100 (high functioning).

次要结局

  • Three-Day Dietary Intake Record(13 weeks post-baseline)
  • The Health Questionnaire (EuroQoL EQ-5D)(13 weeks post-baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验