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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Aspiration pneumonia
Tidsramme: 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.
|
Up to day 365
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nutrition Risk Screening 2002
Tidsramme: 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.
|
day 0, day 181 and day 366
|
|
Dysphagia Outcome and Severity Scale
Tidsramme: 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.
|
day 0, day 181 and day 366
|
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Dysphagia Handicap Index
Tidsramme: 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.
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day 0, day 181 and day 366
|
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Barthel Index
Tidsramme: 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.
|
day 0, day 181 and day 366
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospitalization
Tidsramme: 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.
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Up to day 365
|
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Mortality
Tidsramme: Up to day 365
|
Hospitalization will be determined based on Death records
|
Up to day 365
|
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Patient-physician trust
Tidsramme: 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.
|
day 0, day 181 and day 366
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SIMEI Study
Legemiddel- og utstyrsinformasjon, studiedokumenter
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