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NCT Number: NCT07563465

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

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this 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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Aspiration pneumonia

    Time frame: Up to day 365

    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.

Secondary outcomes

  1. Nutrition Risk Screening 2002

    Time frame: day 0, day 181 and day 366

    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.

  2. Dysphagia Outcome and Severity Scale

    Time frame: day 0, day 181 and day 366

    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.

  3. Dysphagia Handicap Index

    Time frame: day 0, day 181 and day 366

    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.

  4. Barthel Index

    Time frame: day 0, day 181 and day 366

    Barthel Index is used to assess functional dependence. The total score ranges from 0 to 100, with the higher score indicating better functional independence.

Other outcomes

  1. Hospitalization

    Time frame: Up to day 365

    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.

  2. Mortality

    Time frame: Up to day 365

    Hospitalization will be determined based on Death records

  3. Patient-physician trust

    Time frame: day 0, day 181 and day 366

    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.

Sponsors and collaborators

Lead sponsor

Zeng Xi

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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