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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Aspiration pneumonia
Lasso di tempo: 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.
|
Up to day 365
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Nutrition Risk Screening 2002
Lasso di tempo: 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
Lasso di tempo: 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.
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day 0, day 181 and day 366
|
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Dysphagia Handicap Index
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hospitalization
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SIMEI Study
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