An interventional study of mHealth intervention in Stroke and Deglutition Disorders, sponsored by University of Cadiz. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by University of Cadiz · Not applicable, Interventional, and Treatment
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:
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 74 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Cadiz is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject Withdrawal Criteria:
This group will receive the mHealth intervention via the mobile application "DegluApp".
Other: mHealth intervention
This group will perform conventional care according to the healthcare centers' protocols.
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.
Dysphagia Improvement and Recovery
Dysphagia Improvement and Recovery. Dichotomous qualitative variable: Yes, No.
Time frame: Day 1, 3 months, 6 months, and 9 months
Type of texture
Type of texture and volume the patient follows in their habitual diet. Categorical qualitative variable: Liquid, Nectar, Honey, Pudding.
Time frame: Day 1, 3 months, 6 months, and 9 months
Volume allowed when swallowing
Volume the patient follows in their habitual diet. Categorical qualitative variable: 5 mL, 10 mL, and 20 mL
Time frame: Day 1, 3 months, 6 months, and 9 months
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).
Time frame: Day 1, 3 months, 6 months, and 9 months
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).
Time frame: Day 1, 3 months, 6 months, and 9 months
Weight
Continuous quantitative variable: kg.
Time frame: Day 1, 3 months, 6 months, and 9 months
Height
Continuous quantitative variable: cm.
Time frame: Day 1, 3 months, 6 months, and 9 months
Body Mass Index
Continuous quantitative variable: kg/m².
Time frame: Day 1, 3 months, 6 months, and 9 months
Anthropometric variables
Circumferences (arm and calf). Continuous quantitative variable. Unit of measurement: Millimeters (mm).
Time frame: Day 1, 3 months, 6 months, and 9 months
Dynamometry
Body dynamometry measures the maximum voluntary isometric contraction (MVIC), which is the greatest force a muscle can generate without changing its length, or isokinetic strength, which is the force generated across a range of motion at a constant angular velocity. The primary variable is force, which reflects the muscle's ability to produce tension. Continuous quantitative variable. In general clinical practice using a handgrip dynamometer (a common and standardized measure), minimum values can be very low (e.g., under 10 kg for older, frail, or sarcopenic individuals). Very low values are often indicative of frailty or severe muscle wasting. Maximum values can reach or exceed 60 kg for strong, healthy, and athletic adult men. Unit of measurement: kg.
Time frame: Day 1, 3 months, 6 months, and 9 months
Diet
Diet serves to classify subjects into distinct, non-ordered categories based on their primary eating patterns (omnivore, vegetarian, vegan, pescatarian, keto, mediterranean). Nominal qualitative variable.
Time frame: Day 1, 3 months, 6 months, and 9 months
Dietary Intake
Categorical qualitative variable: 25%, 50%, 75%, and 100%.
Time frame: Day 1, 3 months, 6 months, and 9 months
Sarcopenia
Dichotomous qualitative variable: SARC-F Questionnaire (Strength, Assistance in walking, Rise from a chair, Climb stairs, Falls). The SARC-F measures five key components related to muscle function and strength, which are reported by the individual being assessed. Each component is scored from 0 to 2 points. The total score is the sum of the points from the five components, resulting in a range from a minimum value of 0, which indicates the lowest risk for sarcopenia, to a maximum value of 10 (5 components x 2 points/component), which indicates the highest risk for sarcopenia. The SARC-F is primarily interpreted using a simple cut-off point for screening: a score of \>4 points is considered positive and indicates a high risk for sarcopenia.
Time frame: Day 1, 3 months, 6 months, and 9 months
Nutritional Status
Discrete quantitative variable: Mini-Nutritional Assessment (MNA). It is designed to identify elderly individuals who are malnourished or at risk of malnutrition. It comprehensively evaluates several factors that influence nutritional status, including anthropometric measurements, general lifestyle and functional capacity, dietary changes, and self-perception of health and nutritional status. It is crucial for early intervention in geriatric care. The MNA produces a single score ranging from a minimum value of 0 (indicating severe malnutrition) to a maximum value of 30 (indicating satisfactory nutritional status). Scores are then grouped into categories: \<17 (malnourished), 17.5 to 23.5 (at risk of malnutrition), and \> 24 (well-nourished).
Time frame: Day 1, 3 months, 6 months, and 9 months
Caregiver Burden
Categorical qualitative variable: Zarit Burden Interview (ZBI). The ZBI assesses the subjective stress, strain, and emotional distress felt by the caregiver. It consists of 22 items (in the full version) rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Nearly always). The total score is the sum of the points from all 22 items, resulting in a range from a minimum value of 0, which indicates no burden is perceived by the caregiver, to a maximum value of 88 (22 items x 4 points/item), which indicates the highest level of perceived burden. The score is interpreted using established cut-off points to categorize the level of burden: scores typically ranging from 0 to 20 suggest no or minimal burden; scores between 21 and 40 indicate mild to moderate burden; scores from 41 to 60 suggest moderate to severe burden; and scores from 61 to 88 denote severe burden.
Time frame: Day 1, 3 months, 6 months, and 9 months
Caregiver Strain
Discrete quantitative variable: Caregiver Strain Index. The CSI measures the caregiver's perception of strain across three main domains related to their caregiving role: Financial Strain, Physical Strain, and Emotional and Social Strain. The questionnaire consists of ten statements about common sources of strain. The caregiver responds to each item with a simple "yes" (strain is present) or "no" (strain is absent). The total score is calculated by summing the number of "yes" responses. The score ranges from a minimum value of 0, which indicates no strain is perceived by the caregiver, to a maximum value of 10 (10 items x 1 point/item), which indicates the highest level of perceived strain. The CSI is interpreted using a key cut-off point: a score of \>7 points is generally considered clinically significant, indicating a high level of caregiver strain.
Time frame: Day 1, 3 months, 6 months, and 9 months
Fat Mass
The total amount of stored fat in the body, including essential (vital for life and reproductive functions) and non-essential (storage) fat. It's a key component in assessing body composition, often used to determine the degree of obesity and related health risks. Continuous quantitative variable. A healthy minimum body fat percentage for men is around 5%, and for women, around 10-13% (due to essential fat). Absolute minimum for survival is closer to 1-3% for men and 8-12% for women, but these are dangerously low values. Maximum value can exceed 50% of total body weight in cases of severe obesity. There is no biological maximum, but values over 40% often indicate high health risk. Unit of measurement: Kilograms (kg or %).
Time frame: Day 1, 3 months, 6 months, and 9 months
Fat-Free Mass
The portion of the body that does not contain fat. It is composed primarily of muscle, bone, water, and internal organs (e.g., bone mineral mass, protein mass). It represents the metabolically active tissue and is a major determinant of Basal Metabolic Rate (BMR). Continuous quantitative variable. Minimum value varies widely based on height and body type, but generally represents a large proportion of total weight, typically over 50% of total body mass. Maximum value highly dependent on the individual's size, muscle mass, and hydration status. Unit of measurement: Kilograms (kg).
Time frame: Day 1, 3 months, 6 months, and 9 months
Body Water
The total amount of water in the human body, encompassing both Intracellular Fluid (ICF) and Extracellular Fluid (ECF). Water is the largest component of Fat-Free Mass and is essential for nearly all physiological functions. It is a key indicator of hydration status. Continuous quantitative variable. Minimum value represents a large part of the body. Healthy adult men typically have 50-65% of their body mass as water, while healthy adult women typically have 45-60%. Values below this can indicate severe dehydration. Maximum value cannot biologically exceed the physiological upper limit (around 65-70% for the general population), as body water is homeostatically controlled. Excessively high values may indicate conditions like edema. Unit of measurement: Liters (L), Kilograms (kg), or Percentage (%) of total body weight.
Time frame: Day 1, 3 months, 6 months, and 9 months
Phase Angle
A raw measure derived from Bioelectrical Impedance Analysis (BIA) that relates the resistance and reactance of body tissues. It is a non-invasive indicator of cellular health, integrity, and function. A higher phase angle is generally associated with greater cell membrane integrity, better nutritional status, and greater muscle mass. A lower angle may indicate cell breakdown, poor health, or malnutrition. Minimum value can be as low as 2º or 3º in severely malnourished, ill, or elderly patients. Maximum value typically ranges up to 9º or 10º in healthy, muscular, or athletic individuals. Unit of measurement: Degrees (º).
Time frame: Day 1, 3 months, 6 months, and 9 months
Sex
Dichotomous qualitative variable: Female, Male.
Time frame: Day 1
Age
Discrete quantitative variable: years.
Time frame: Day 1
Presence of caregiver
Dichotomous qualitative variable: Yes, No.
Time frame: Day 1
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.
Time frame: Day 1, 3 months, 6 months, and 9 months
Frailty
Through Fried criteria. It is a widely recognized and simple clinical method used to identify and classify the physical frailty status of older adults. It specifically focuses on the physical decline associated with aging. The result of the Fried Criteria is a count of the deficits (criteria) met, ranging from 0 to 5. Minimum value: 0, which indicates the individual is considered Non-frail (or Robust). Maximum value: 5, which means the individual meets all five criteria, indicating Severe Frailty. The results are typically categorized into three clinical states: Robust/Non-frail (0 criteria met), Pre-frail (1 or 2 criteria met), Frail (3 or more criteria met).
Time frame: Day 1, 3 months, 6 months, and 9 months
Risk of falls
Categorical qualitative variable: Falls Risk Detection Scale. It is a clinical screening tool used primarily in hospital and institutional settings to assess a patient's risk of falling. Its main purpose is to quickly identify individuals who require preventative measures to reduce their risk of falls during their stay. Minimum value: 0, indicating the lowest risk of falling. Maximum value: The maximum possible score can vary significantly, often up to 90 or more, indicating the highest risk of falling. Score Range: Low risk (0-24 points), moderate risk (25-50 points), high risk (\>50 points).
Time frame: Day 1, 3 months, 6 months, and 9 months
Hospital admissions
Discrete quantitative variable: number of admissions.
Time frame: Day 1, 3 months, 6 months, and 9 months
Length of time a patient remains in the hospital
Continuous quantitative variable: days.
Time frame: Day 1, 3 months, 6 months, and 9 months
Economic cost
Continuous quantitative variable: euros. Will be calculated by multiplying the days of admission or hospital stay by the daily cost of life.
Time frame: Day 1, 3 months, 6 months, and 9 months
Presence of aspiration
Discrete quantitative variable: number of aspiration episodes.
Time frame: Day 1, 3 months, 6 months, and 9 months
Presence of respiratory infection
Discrete quantitative variable: number of respiratory infection episodes.
Time frame: Day 1, 3 months, 6 months, and 9 months
Presence of aspiration-derived pneumonia
Discrete quantitative variable: number of aspiration-derived pneumonia episodes.
Time frame: Day 1, 3 months, 6 months, and 9 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data obtained in the study will be anonymized and will be published collectively in a database at the time of the publication of the research results.
Supporting information: Study protocol, Sap, Icf
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