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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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. |
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Geen tussenkomst: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Aspiration pneumonia
Tijdsspanne: Up to day 365
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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.
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Up to day 365
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Nutrition Risk Screening 2002
Tijdsspanne: day 0, day 181 and day 366
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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.
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day 0, day 181 and day 366
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Dysphagia Outcome and Severity Scale
Tijdsspanne: day 0, day 181 and day 366
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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.
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day 0, day 181 and day 366
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Dysphagia Handicap Index
Tijdsspanne: day 0, day 181 and day 366
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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.
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day 0, day 181 and day 366
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Barthel Index
Tijdsspanne: day 0, day 181 and day 366
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Barthel Index is used to assess functional dependence.
The total score ranges from 0 to 100, with the higher score indicating better functional independence.
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day 0, day 181 and day 366
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Hospitalization
Tijdsspanne: Up to day 365
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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.
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Up to day 365
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Mortality
Tijdsspanne: Up to day 365
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Hospitalization will be determined based on Death records
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Up to day 365
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Patient-physician trust
Tijdsspanne: day 0, day 181 and day 366
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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.
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day 0, day 181 and day 366
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SIMEI Study
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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