Effectiveness of an mHealth Intervention, Based on Rehabilitation and a Personalised Nutrition Plan, in the Recovery and Improvement of Dysphagia in Patients Diagnosed With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Dysphagia Improvement and Recovery
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of an mHealth intervention as a complement to usual clinical practice for the improvement and recovery of dysphagia in patients who have suffered a stroke. The main question it aims to answer is:
- Does the mHealth intervention improve the recovery of dysphagia in post-stroke patients compared to usual care alone?
Researchers will compare patients receiving the mHealth intervention plus usual care to see if the combined approach leads to better dysphagia outcomes, reduced negative consequences (e.g., malnutrition, pneumonia), and improved quality of life compared to usual care alone.
Participants will be recruited and:
- Receive a diagnosis and usual care for post-stroke dysphagia.
- Be assigned to either the mHealth intervention group (using a smartphone/tablet app for information and follow-up) or the control group (usual care only).
- Be followed up to assess dysphagia recovery, reduction in negative outcomes (like aspiration pneumonia, dehydration), and changes in quality of life.
详细描述
Stroke is one of the leading causes of death and disability globally, and is associated with negative complications and increased socio-health costs. Among the complications derived from a stroke is dysphagia, defined as difficulty swallowing, which is associated with increased morbidity and mortality. Up to 80% of patients who have a stroke have difficulty swallowing. Furthermore, this is more pronounced in older adults, as the oropharyngeal swallowing response is affected in this population. Dysphagia is a significant predictor of negative outcomes such as malnutrition, dehydration, tracheobronchial aspiration, pneumonia, and death derived from pneumonia, low mood, and depression, etc. These consequences reduce the perception of quality of life for patients with dysphagia. Early intervention and the continuity of this intervention at home reduce the negative consequences of dysphagia. Currently, the majority of the population owns a smartphone or tablet and uses mobile applications (apps) in their daily lives to communicate, seek information, etc. Mobile technology can be a useful support tool for health professionals, facilitating information and follow-up for post-stroke patients with dysphagia and empowering patients and family members in managing their health. The general objective of this study is to evaluate the efficacy of an mHealth intervention, as a complement to usual clinical practice, for the improvement and recovery of dysphagia in patients who have suffered a stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The random allocation of participants will also be blinded to the researchers.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 years or older.
- •Patients with any degree of impairment in swallowing/oropharyngeal dysphagia to liquids following a stroke (ACV).
排除标准
- •Hospitalized patients presenting any type of visual barrier.
- •Patients in terminal palliative care.
- •Patients in the final days of life phase.
- •Patients with severe cognitive impairment.
- •Patients with a language barrier regarding the use of the App.
- •Subject Withdrawal Criteria:
- •Revocation of consent. In this case, the subject will exit the study and will not be replaced by another subject, being considered a "loss".
- •Lack of adherence to the prescribed training plan exceeding 20% of the scheduled sessions.
研究组 & 干预措施
mHealth Group
This group will receive the mHealth intervention via the mobile application "DegluApp".
干预措施: mHealth intervention (Other)
No intervention Group
This group will perform conventional care according to the healthcare centers' protocols.
结局指标
主要结局
Dysphagia Improvement and Recovery
时间窗: Day 1, 3 months, 6 months, and 9 months
Dysphagia Improvement and Recovery. Dichotomous qualitative variable: Yes, No.
Volume allowed when swallowing
时间窗: Day 1, 3 months, 6 months, and 9 months
Volume the patient follows in their habitual diet. Categorical qualitative variable: 5 mL, 10 mL, and 20 mL
Type of texture
时间窗: Day 1, 3 months, 6 months, and 9 months
Type of texture and volume the patient follows in their habitual diet. Categorical qualitative variable: Liquid, Nectar, Honey, Pudding.
Acceptable viscosity when swallowing
时间窗: Day 1, 3 months, 6 months, and 9 months
Measured using the Volume-Viscosity Swallow Test (V-VST). The test is performed using three different viscosities (thin liquid, nectar-thick, and pudding-thick) and three different volumes 3 ml, 5 ml, and 20 ml) to determine the volume-viscosity combination that is safest and most efficient for the patient. It is a clinical diagnostic tool used to evaluate the efficacy and safety of a patient's swallowing function (deglutition) by systematically challenging it with a controlled set of liquid volumes and viscosities. It contains two main safety and efficiency markers. For the Safety Scale (aspiration/penetration), levels typically range from a minimum of 0 (no safety issues detected) to a maximum of 2 (indicating severe issues like persistent cough or desaturation). Similarly, the Efficiency Scale might range from Level 0 (efficient swallow) to Level 1 (reduced efficiency).
次要结局
- Perceived quality of life(Day 1, 3 months, 6 months, and 9 months)
- Weight(Day 1, 3 months, 6 months, and 9 months)
- Height(Day 1, 3 months, 6 months, and 9 months)
- Body Mass Index(Day 1, 3 months, 6 months, and 9 months)
- Diet(Day 1, 3 months, 6 months, and 9 months)
- Anthropometric variables(Day 1, 3 months, 6 months, and 9 months)
- Dynamometry(Day 1, 3 months, 6 months, and 9 months)
- Dietary Intake(Day 1, 3 months, 6 months, and 9 months)
- Sarcopenia(Day 1, 3 months, 6 months, and 9 months)
- Nutritional Status(Day 1, 3 months, 6 months, and 9 months)
- Phase Angle(Day 1, 3 months, 6 months, and 9 months)
- Caregiver Burden(Day 1, 3 months, 6 months, and 9 months)
- Caregiver Strain(Day 1, 3 months, 6 months, and 9 months)
- Fat Mass(Day 1, 3 months, 6 months, and 9 months)
- Fat-Free Mass(Day 1, 3 months, 6 months, and 9 months)
- Body Water(Day 1, 3 months, 6 months, and 9 months)
研究者
Antonio Jesús Marín Paz
Collaborator Investigator
University of Cadiz