System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients With Dysphagia

NCT07563465 | Not Yet Recruiting

• 1 other identifier: SIMEI Study
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to explore the effects of the system-integrated technology-enabled model of care in ischemic stroke patients with dysphagia. The main question it aims to answer is: Can one-year system-integrated technology-enabled model of care improve the incidence of aspiration pneumonia, swallowing function, nutritional status, self-care ability, and quality of life among post-discharge ischemic stroke patients with dysphagia. Researchers will compare system-integrated technology-enabled model group and control group to see if there are significant intergroup differences in the incidence of aspiration pneumonia, swallowing function, nutritional status, self-care ability, and quality of life. Participants will be divided into the system-integrated technology-enabled model group and the control group. Participants in the system-integrated technology-enabled model group will receive support and follow-up services for dysphagia management, as well as physician-patient communication, with the assistance of mobile phones for one year. Participants in the control group will receive routine management.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Aspiration pneumonia

  Participants are monitored for the occurrence of aspiration pneumonia, with the standard being the diagnosis issued by the hospital. Participants or their relatives are required to regularly submit information regarding their pneumonia.

  Up to day 365

Secondary Outcomes (4)

• Nutrition Risk Screening 2002

  day 0, day 181 and day 366

• Dysphagia Outcome and Severity Scale

  day 0, day 181 and day 366

• Dysphagia Handicap Index

  day 0, day 181 and day 366

• Barthel Index

  day 0, day 181 and day 366

Other Outcomes (3)

• Hospitalization

  Up to day 365

• Mortality

  Up to day 365

• Patient-physician trust

  day 0, day 181 and day 366

Study Arms (2)

system-integrated technology-enabled model group

EXPERIMENTAL

Participants in the system-integrated technology-enabled model group will receive support and follow-up services for dysphagia management, as well as physician-patient communication, with the assistance of mobile phones for one year. The doctors in the system-integrated technology-enabled model group will receive systematic cascade training by specialists on clinical guidelines, essential medicines, nutritional management and behavior change.

Behavioral: System-integrated Technology-enabled Model of Care

control group

NO INTERVENTION

Control group will continue their routine practices without any intervention. No specific medical services will be provided for participants in the control group. Physicians will deliver clinical services including, but not limited to, scheduled follow-ups and prescription issuance based on patients' needs.

Interventions

System-integrated Technology-enabled Model of Care BEHAVIORAL

The System-integrated Technology-enabled Model of Care includes the following components: enhanced monitoring and corresponding countermeasures for patients' daily diet, living habits and physical conditions via mobile devices; increased frequency of physician-patient communication; provision of dysphagia-related knowledge training and management guidance for county-level hospitals; delivery of swallowing-related health education to patients; and incentives. Doctors from trial site hospitals will be trained, and establish professional connections between doctors from higher-level hospitals. Participants and their family members will receive regular follow-up, online doctor-participant meetings, and online support groups with fellow participants via the mobile platform. The platform also provides convenient access to educational materials, timed reminders, and messaging functions.

system-integrated technology-enabled model group

Eligibility Criteria

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

You may qualify if:

• discharged ischemic stroke survivors
• disease duration ≤3 months
• Dysphagia Outcome and Severity Scale grade ranging 1-5 levels.
• stable vital signs, out of the acute phase, and not requiring long-term bed rest and monitoring.
• reside locally for the next year.
• basic communication ability and offering informed consent.
• having and being able to use smart phones.
• free from aspiration pneumonia or its symptoms

You may not qualify if:

• expected lifespan ≤1 year
• other severe systemic diseases.
• participating in other clinical trials.
• severe cognitive or psychiatric disorders, or severe aphasia.
• pregnant or lactating women.

Sponsors & Collaborators

• Zeng Xi: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04