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

NCT07267468 | Recruiting

• 1 other identifier: AP-0331-2022-C3-F2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Deglutition Disorders

Keywords

Stroke; Deglutition Disorders; Pneumonia, Aspiration; Nutrition; Rehabilitation; mHealth

Outcome Measures

Primary Outcomes (4)

• Dysphagia Improvement and Recovery

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

  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.

  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

  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).

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

Secondary Outcomes (16)

• Perceived quality of life

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

• Weight

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

• Height

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

• Body Mass Index

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

• Anthropometric variables

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

Other Outcomes (12)

• Sex

  Day 1

• Age

  Day 1

• Presence of caregiver

  Day 1

Study Arms (2)

mHealth Group

EXPERIMENTAL

This group will receive the mHealth intervention via the mobile application "DegluApp".

Other: mHealth intervention

No intervention Group

NO INTERVENTION

This group will perform conventional care according to the healthcare centers' protocols.

Interventions

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.

mHealth Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• Andalusian Health Service: collaborator

Study Sites (1)

Faculty of Nursing. Punta Europa University Hospital

Algeciras, Cadiz, 11207, Spain

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Stroke; Deglutition Disorders; Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eduardo Sánchez-Sánchez, Ph.D.

  University of Cadiz. Andalusian Healthcare Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The random allocation of participants will also be blinded to the researchers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 5, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study Protocol: October 2025. Informed Consent Form: October-November 2025. Statistical Analysis Plan: October-November 2025. Database of results: At the time of the publication of the research results.
• Access Criteria: All data will be incorporated in open access both into this research protocol and at the time of the publication of the research results.

Locations

ES (1)