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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое mHealth intervention
  The intervention consists of using the validated mobile application "DegluApp", which contains recommendations and exercises related to nutrition, physical activity, rehabilitation, warning signs, and games pertinent to the daily life of a person with post-stroke dysphagia.

Первичные конечные точки

• Dysphagia Improvement and Recovery [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Type of texture [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Volume allowed when swallowing [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Acceptable viscosity when swallowing [Срок оценки: Day 1, 3 months, 6 months, and 9 months]

Вторичные конечные точки (12)

• Perceived quality of life [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Weight [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Height [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Body Mass Index [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Anthropometric variables [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Dynamometry [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Diet [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Dietary Intake [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Sarcopenia [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Nutritional Status [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Caregiver Burden [Срок оценки: Day 1, 3 months, 6 months, and 9 months]
• Caregiver Strain [Срок оценки: Day 1, 3 months, 6 months, and 9 months]

Критерии участия

Критерии включения

• Subjects aged 18 years or older.
• Patients with any degree of impairment in swallowing/oropharyngeal dysphagia to liquids following a stroke (ACV).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Faculty of Nursing. Punta Europa University Hospital — Algeciras

Публикации

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Идентификаторы

NCT: NCT07267468 · AP-0331-2022-C3-F2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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