- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07641101
Effects Of App-Supported Transitional Care On Neurogenic Bladder In Spinal Cord Injury Patients
Effects Of App-Supported Transitional Care On Bladder Function And Quality Of Life in Patients With Neurogenic Bladder After Incomplete Spinal Cord Injury: A Randomised Controlled Trial
Studieoversigt
Status
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Jilin
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Siping, Jilin, Kina, 136000
- Siping Central People's Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Diagnosed with neurogenic bladder secondary to incomplete spinal cord injury; Age ranging from 18 to 75 years old; Clear consciousness, capable of cooperating with nursing assessment and mobile APP follow-up management; Voluntarily sign written informed consent. -
Exclusion Criteria:
Combined with severe renal insufficiency, malignant tumor or other life-threatening severe systemic diseases; History of previous bladder reconstructive surgery; Cognitive impairment unable to independently operate mobile APP; Refuse to continue follow-up or withdraw voluntarily during the research period.
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Control Group
Patients receive routine standardized inpatient bladder nursing, only one-time routine telephone follow-up after discharge without APP-based transitional care intervention
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routine standardized inpatient bladder nursing
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Eksperimentel: Intervention Group
Same routine inpatient nursing as control group plus 4 weeks of systematic APP-supported transitional care including health education, voiding record management and online nurse consultation.
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routine standardized inpatient bladder nursing
Four-week continuous transitional nursing service via mobile APP for patients with neurogenic bladder after incomplete spinal cord injury, including disease-related health education, real-time voiding record, regular nursing reminder and online one-on-one nurse consultation, which differs from routine single telephone follow-up in control group.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of urinary tract infection
Tidsramme: Within 4 weeks after subject enrollment
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Count the occurrence of urinary tract infection within 4-week follow-up and calculate infection incidence of each group.
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Within 4 weeks after subject enrollment
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Post-void residual urine volume
Tidsramme: Baseline and 4 weeks after intervention
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Bladder residual urine volume is measured by ultrasonic examination at baseline and after 4 weeks of nursing intervention to compare the difference between two groups.
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Baseline and 4 weeks after intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-care ability and quality of life score
Tidsramme: Baseline and 4 weeks after intervention
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Standardized scale scoring for self-care and quality of life before and after 4-week transitional nursing.
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Baseline and 4 weeks after intervention
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Neurologiske manifestationer
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Sår og skader
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Traumer, nervesystemet
- Urinblæresygdomme
- Rygmarvssygdomme
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Rygmarvsskader
- Urinblære, neurogen
Andre undersøgelses-id-numre
- SKYLW-2024-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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