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

Overview

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.

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.

Interventions

• Other mHealth intervention
  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 outcome measures

• Dysphagia Improvement and Recovery [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Type of texture [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Volume allowed when swallowing [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Acceptable viscosity when swallowing [Time frame: Day 1, 3 months, 6 months, and 9 months]

Secondary outcome measures (12)

• Perceived quality of life [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Weight [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Height [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Body Mass Index [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Anthropometric variables [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Dynamometry [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Diet [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Dietary Intake [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Sarcopenia [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Nutritional Status [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Caregiver Burden [Time frame: Day 1, 3 months, 6 months, and 9 months]
• Caregiver Strain [Time frame: Day 1, 3 months, 6 months, and 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Faculty of Nursing. Punta Europa University Hospital — Algeciras

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 31204385

Identifiers

NCT: NCT07267468 · AP-0331-2022-C3-F2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗