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.
Subjects aged 18 years or older.
Patients with any degree of impairment in swallowing/oropharyngeal dysphagia to liquids following a stroke (ACV).
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.
Parallel
mHealth intervention
Other interventionThe 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.
Dysphagia Improvement and Recovery
Dysphagia Improvement and Recovery. Dichotomous qualitative variable: Yes, No.
Type of texture
Type of texture and volume the patient follows in their habitual diet. Categorical qualitative variable: Liquid, Nectar, Honey, Pudding.
Volume allowed when swallowing
Volume the patient follows in their habitual diet. Categorical qualitative variable: 5 mL, 10 mL, and 20 mL
Acceptable viscosity when swallowing
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).
Perceived quality of life
Categorical qualitative variable: EuroQoL 5 Dimensions - 5 Levels (EuroQoL 5D-5L). They are scored using a 5-point Likert scale (1. No problem; 5. Unable). The sixth dimension scores ranging from 0 (worst health status) to 100 (best health status).
Weight
Continuous quantitative variable: kg.
Height
Continuous quantitative variable: cm.
Body Mass Index
Continuous quantitative variable: kg/m².
Sex
Dichotomous qualitative variable: Female, Male.
Age
Discrete quantitative variable: years.
Presence of caregiver
Dichotomous qualitative variable: Yes, No.
Degree of dependence for performing Activities of Daily Living
Categorical qualitative variable: Barthel Index. It is a foundational ordinal scale used primarily in rehabilitation and geriatric medicine to measure a person's level of independence in activities of daily living (ADLs) and functional mobility. It assesses ten essential areas: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers (bed to chair), mobility (walking or wheelchair), and climbing stairs. The total score reflects the individual's ability to perform these tasks with or without assistance, providing a clear indication of their care needs and the effectiveness of rehabilitation interventions. The Barthel Index ranges from a minimum value of 0, which signifies a totally dependent state requiring maximum assistance in all activities, to a maximum value of 100, which indicates complete independence in all ten functional areas.
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University of Cadiz
Lead sponsor
Andalusian Health Service
Collaborator
