System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients With Dysphagia
ConditionDysphagia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZeng Xi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
expected lifespan ≤1 year
other severe systemic diseases.
participating in other clinical trials.
severe cognitive or psychiatric disorders, or severe aphasia.
Trial design
Design model
Parallel
Treatments tested in this trial
System-integrated Technology-enabled Model of Care
BehavioralThe 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: system-integrated technology-enabled model groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Up to day 365Secondary outcomes
1
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.
Time frame
day 0, day 181 and day 3662
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.
Time frame
day 0, day 181 and day 3663
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.
Time frame
day 0, day 181 and day 3664
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.
Time frame
day 0, day 181 and day 366Other outcomes
1
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.
Time frame
Up to day 3652
Mortality
Hospitalization will be determined based on Death records
Time frame
Up to day 3653
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.
Time frame
day 0, day 181 and day 366Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zeng Xi
Lead sponsor
People's Hospital of Zhengzhou University
Sponsor institution
Source ClinicalTrials.gov
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