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

System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients With Dysphagia: a Cluster-randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Behavioral: System-integrated Technology-enabled Model of Care

Detailed Description

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.

This study will last for one year per participant and the entire study will be conducted in China.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: system-integrated technology-enabled model 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. 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; 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.
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition Risk Screening 2002	Nutrition Risk Screening 2002 is a tool used to assess nutritional risk. The total score ranges from 0 to 7, with a score of 3 or higher indicating the presence of nutritional risk.	day 0, day 181 and day 366
Dysphagia Outcome and Severity Scale	The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. A higher level indicates better swallowing function.	day 0, day 181 and day 366
Dysphagia Handicap Index	Dysphagia Handicap Index is used to assess quality of life. The total score ranges from 0 to 100, with the higher score indicating worse quality of life.	day 0, day 181 and day 366
Barthel Index	Barthel Index is used to assess functional dependence. The total score ranges from 0 to 100, with the higher score indicating better functional independence.	day 0, day 181 and day 366

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Hospitalization will be determined based on self-reporting and must be verified with corresponding official documentation, defined as admission to an inpatient department with an overnight stay of at least one day.	Up to day 365
Mortality	Hospitalization will be determined based on Death records	Up to day 365
Patient-physician trust	Patient-physician trust is evaluated using the self-administered Trust in Physician Scale subscale, with a total score ranging from 4 to 20 points. A higher score indicates a higher level of patient trust in their physician.	day 0, day 181 and day 366

Collaborators and Investigators

• Sponsor: Zeng Xi

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: SIMEI Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No