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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Aspiration pneumonia
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Nutrition Risk Screening 2002
Časové okno: 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.
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day 0, day 181 and day 366
|
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Dysphagia Outcome and Severity Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hospitalization
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SIMEI Study
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