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StrokeNCT07267468

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

A study testing mHealth intervention in people with Stroke and Deglutition Disorders, run by University of Cadiz at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Deglutition Disorders
What is being tested?
mHealth intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteSpain
Study dates
30 Jan 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eduardo Sánchez-Sánchez, Ph.D. contact

+34 956028110

eduardo.sanchez@uca.es

Antonio-Jesús Marín-Paz, Ph.D. contact

+34 956028106

antoniojesus.marin@uca.es

Spain1 site, 1 recruiting
  • Faculty of Nursing. Punta Europa University Hospital

    Algeciras, Cadiz, 11207

    Eduardo Sánchez-Sánchez, Ph.D., +34 956028110, eduardo.sanchez@uca.es

    Antonio-Jesús Marín-Paz, Ph.D.

    Recruiting

Other trials in Spain

About this study

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?
Read more

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.
Read the detailed description

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.

Being tested
mHealth intervention
Keywords
Stroke, Deglutition Disorders, Pneumonia, Aspiration, Nutrition, Rehabilitation, mHealth
Medical subject headings
Stroke, Deglutition Disorders, Pneumonia, Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth interventionOther

    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.

Study groups in NCT07267468
Study groupRoleWhat they receive
mHealth GroupExperimentalThis group will receive the mHealth intervention via the mobile application "DegluApp".
Receives: Other: mHealth intervention
No intervention GroupNo interventionThis group will perform conventional care according to the healthcare centers' protocols.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dysphagia Improvement and Recovery

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

    Measured: Day 1, 3 months, 6 months, and 9 months

  2. Type of texture

    Type of texture and volume the patient follows in their habitual diet. Categorical qualitative variable: Liquid, Nectar, Honey, Pudding.

    Measured: Day 1, 3 months, 6 months, and 9 months

  3. Volume allowed when swallowing

    Volume the patient follows in their habitual diet. Categorical qualitative variable: 5 mL, 10 mL, and 20 mL

    Measured: Day 1, 3 months, 6 months, and 9 months

  4. 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).

    Measured: Day 1, 3 months, 6 months, and 9 months

Secondary outcomes (16)
  1. 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).

    Measured: Day 1, 3 months, 6 months, and 9 months

  2. Weight

    Continuous quantitative variable: kg.

    Measured: Day 1, 3 months, 6 months, and 9 months

  3. Height

    Continuous quantitative variable: cm.

    Measured: Day 1, 3 months, 6 months, and 9 months

  4. Body Mass Index

    Continuous quantitative variable: kg/m².

    Measured: Day 1, 3 months, 6 months, and 9 months

  5. Anthropometric variables

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

    Measured: Day 1, 3 months, 6 months, and 9 months

  6. 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.

    Measured: Day 1, 3 months, 6 months, and 9 months

  7. 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.

    Measured: Day 1, 3 months, 6 months, and 9 months

  8. Dietary Intake

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

    Measured: Day 1, 3 months, 6 months, and 9 months

  9. 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.

    Measured: Day 1, 3 months, 6 months, and 9 months

  10. 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).

    Measured: Day 1, 3 months, 6 months, and 9 months

  11. 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.

    Measured: Day 1, 3 months, 6 months, and 9 months

  12. 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.

    Measured: Day 1, 3 months, 6 months, and 9 months

  13. 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 %).

    Measured: Day 1, 3 months, 6 months, and 9 months

  14. 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).

    Measured: Day 1, 3 months, 6 months, and 9 months

  15. 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.

    Measured: Day 1, 3 months, 6 months, and 9 months

  16. 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).

    Measured: Day 1, 3 months, 6 months, and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start30 Jan 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07267468
Sponsor's protocol ID
AP-0331-2022-C3-F2
Status last verified
Jan 2026
First submitted
13 Nov 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Hernandez G, Garin O, Dima AL, Pont A, Marti Pastor M, Alonso J, Van Ganse E, Laforest L, de Bruin M, Mayoral K, Serra-Sutton V, Ferrer M; ASTRO-LAB Group. EuroQol (EQ-5D-5L) Validity in Assessing the Quality of Life in Adults With Asthma: Cross-Sectional Study. J Med Internet Res. 2019 Jan 23;21(1):e10178. doi: 10.2196/10178.

    PubMed 30672744
  • Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

    PubMed 7203086
  • Lim ML, Yong BYP, Mar MQM, Ang SY, Chan MM, Lam M, Chong NCJ, Lopez V. Caring for patients on home enteral nutrition: Reported complications by home carers and perspectives of community nurses. J Clin Nurs. 2018 Jul;27(13-14):2825-2835. doi: 10.1111/jocn.14347. Epub 2018 Apr 22.

    PubMed 29518266
  • Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.

    PubMed 9990575
  • Sanchez-Rodriguez D, Marco E, Davalos-Yerovi V, Lopez-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vazquez-Ibar O, Calle A, Inzitari M, Piotrowicz K, Duran X, Escalada F, Muniesa JM, Duarte E. Translation and Validation of the Spanish Version of the SARC-F Questionnaire to Assess Sarcopenia in Older People. J Nutr Health Aging. 2019;23(6):518-524. doi: 10.1007/s12603-019-1204-z.

    PubMed 31233072
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156
  • Guillen-Sola A, Marco E, Martinez-Orfila J, Donaire Mejias MF, Depolo Passalacqua M, Duarte E, Escalada F. Usefulness of the volume-viscosity swallow test for screening dysphagia in subacute stroke patients in rehabilitation income. NeuroRehabilitation. 2013;33(4):631-8. doi: 10.3233/NRE-130997.

    PubMed 24018371
  • Ortega-Martin ME, Lucena-Anton D, Luque-Moreno C, Heredia-Rizo AM, Moral-Munoz JA. [Commercial mobile applications in the therapeutic approach to stroke: Review in main application repositories and scientific evidence]. Rev Esp Salud Publica. 2019 Jun 12;93:e201906035. Spanish.

    PubMed 31204385
  • Teasell R, Salbach NM, Foley N, Mountain A, Cameron JI, Jong A, Acerra NE, Bastasi D, Carter SL, Fung J, Halabi ML, Iruthayarajah J, Harris J, Kim E, Noland A, Pooyania S, Rochette A, Stack BD, Symcox E, Timpson D, Varghese S, Verrilli S, Gubitz G, Casaubon LK, Dowlatshahi D, Lindsay MP. Canadian Stroke Best Practice Recommendations: Rehabilitation, Recovery, and Community Participation following Stroke. Part One: Rehabilitation and Recovery Following Stroke; 6th Edition Update 2019. Int J Stroke. 2020 Oct;15(7):763-788. doi: 10.1177/1747493019897843. Epub 2020 Jan 27.

    PubMed 31983296
  • Marin S, Serra-Prat M, Ortega O, Audouard Fericgla M, Valls J, Palomera E, Cunillera R, Palomeras E, Ibanez JM, Clave P. Healthcare costs of post-stroke oropharyngeal dysphagia and its complications: malnutrition and respiratory infections. Eur J Neurol. 2021 Nov;28(11):3670-3681. doi: 10.1111/ene.14998. Epub 2021 Jul 27.

    PubMed 34176195
  • Kim DY, Park HS, Park SW, Kim JH. The impact of dysphagia on quality of life in stroke patients. Medicine (Baltimore). 2020 Aug 21;99(34):e21795. doi: 10.1097/MD.0000000000021795.

    PubMed 32846813
  • Bath PM, Lee HS, Everton LF. Swallowing therapy for dysphagia in acute and subacute stroke. Cochrane Database Syst Rev. 2018 Oct 30;10(10):CD000323. doi: 10.1002/14651858.CD000323.pub3.

    PubMed 30376602
  • Krajczy E, Krajczy M, Luniewski J, Bogacz K, Szczegielniak J. Assessment of the effects of dysphagia therapy in patients in the early post-stroke period: a randomised controlled trial. Neurol Neurochir Pol. 2019;53(6):428-434. doi: 10.5603/PJNNS.a2019.0053. Epub 2019 Nov 14.

    PubMed 31724147
  • Sura L, Madhavan A, Carnaby G, Crary MA. Dysphagia in the elderly: management and nutritional considerations. Clin Interv Aging. 2012;7:287-98. doi: 10.2147/CIA.S23404. Epub 2012 Jul 30.

    PubMed 22956864
  • Pierpoint M, Pillay M. Post-stroke dysphagia: An exploration of initial identification and management performed by nurses and doctors. S Afr J Commun Disord. 2020 May 28;67(1):e1-e13. doi: 10.4102/sajcd.v67i1.625.

    PubMed 32501033

Questions about this trial

What is this clinical trial studying?

A study testing mHealth intervention in people with Stroke and Deglutition Disorders, run by University of Cadiz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eduardo Sánchez-Sánchez, Ph.D. (+34 956028110, eduardo.sanchez@uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dysphagia Improvement and Recovery (time frame: Day 1, 3 months, 6 months, and 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07267468, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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