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NCT Number: NCT07267468

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing. Punta Europa University Hospital

Algeciras, Cadiz, 11207, Spain

Location status: Recruiting

Location contact

Antonio-Jesús Marín-Paz, Ph.D.

PRINCIPAL_INVESTIGATOR

Eduardo Sánchez-Sánchez, Ph.D.

CONTACT

[email protected]

+34 956028110

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

mHealth intervention

Other

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.

Primary outcomes

  1. Dysphagia Improvement and Recovery

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Dysphagia Improvement and Recovery. Dichotomous qualitative variable: Yes, No.

  2. Type of texture

    Time frame: 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.

  3. Volume allowed when swallowing

    Time frame: 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

  4. Acceptable viscosity when swallowing

    Time frame: 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).

Secondary outcomes

  1. Perceived quality of life

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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).

  2. Weight

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Continuous quantitative variable: kg.

  3. Height

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Continuous quantitative variable: cm.

  4. Body Mass Index

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Continuous quantitative variable: kg/m².

  5. Anthropometric variables

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Circumferences (arm and calf). Continuous quantitative variable. Unit of measurement: Millimeters (mm).

  6. Dynamometry

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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.

  7. Diet

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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.

  8. Dietary Intake

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Categorical qualitative variable: 25%, 50%, 75%, and 100%.

  9. Sarcopenia

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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.

  10. Nutritional Status

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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).

  11. Caregiver Burden

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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.

  12. Caregiver Strain

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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.

  13. Fat Mass

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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 %).

  14. Fat-Free Mass

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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).

  15. Body Water

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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.

  16. Phase Angle

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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).

Other outcomes

  1. Sex

    Time frame: Day 1

    Dichotomous qualitative variable: Female, Male.

  2. Age

    Time frame: Day 1

    Discrete quantitative variable: years.

  3. Presence of caregiver

    Time frame: Day 1

    Dichotomous qualitative variable: Yes, No.

  4. Degree of dependence for performing Activities of Daily Living

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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.

  5. Frailty

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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).

  6. Risk of falls

    Time frame: Day 1, 3 months, 6 months, and 9 months

    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).

  7. Hospital admissions

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Discrete quantitative variable: number of admissions.

  8. Length of time a patient remains in the hospital

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Continuous quantitative variable: days.

  9. Economic cost

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Continuous quantitative variable: euros. Will be calculated by multiplying the days of admission or hospital stay by the daily cost of life.

  10. Presence of aspiration

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Discrete quantitative variable: number of aspiration episodes.

  11. Presence of respiratory infection

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Discrete quantitative variable: number of respiratory infection episodes.

  12. Presence of aspiration-derived pneumonia

    Time frame: Day 1, 3 months, 6 months, and 9 months

    Discrete quantitative variable: number of aspiration-derived pneumonia episodes.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio-Jesús Marín-Paz, Ph.D.

CONTACT

[email protected]

+34 956028106

Eduardo Sánchez-Sánchez, Ph.D.

CONTACT

[email protected]

+34 956028110

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Andalusian Health Service

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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