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Omfattende styring af højrisikopopulation af slagtilfælde baseret på socialt netværk (COMPLIANCE-MT)

6. maj 2026 opdateret af: Changhai Hospital

Omfattende styring af højrisikopopulation af slagtilfælde baseret på socialt netværk: en multicenter, parallel og randomiseret kontrolleret undersøgelse

Formålet med denne undersøgelse er at evaluere effektiviteten af ​​sociale netværk til at forbedre overholdelse af lægemidler og risikofaktorer for at kontrollere antallet af slagtilfælde højrisikopopulationer efter udskrivelse.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Slagtilfælde er den førende dødsårsag blandt indbyggere i Kina, med karakteristika af høj sygelighed, høj dødelighed, høj invaliditetsrate, høj recidivrate og så videre, hvilket medfører en enorm økonomisk byrde for patienternes familier og samfund. Styrkelse af den omfattende håndtering af højrisikopopulationen for slagtilfælde, forbedring af patienternes medicinoverholdelse og kontrolfrekvensen af ​​risikofaktorer for slagtilfælde spiller en nøglerolle i at reducere tilbagefald af slagtilfælde.

Denne undersøgelse er et multicenter, prospektivt, randomiseret, enkelt-blindt studie, som har til formål at bruge værktøjet fra WeChat Mini-programmer til at realisere post-hospital opfølgningshåndtering af højrisikopopulationen for slagtilfælde. Opfølgningstiden er 12 måneder. Det primære målingsresultat var ændringen af ​​patienternes efterlevelse af medicin efter omfattende behandling.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

720

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200433
        • Changhai Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Alder ≥18 år
  • Højrisikopopulation for slagtilfælde til indlæggelse
  • Modificeret Rankin Scale-score≤ 2
  • Patienter eller primære plejere har smartphone- og wechat-konti
  • Patienter tager mindst ét ​​lægemiddel i lang tid (antihypertensiv, hypoglykæmisk, lipidsænkende, antikoagulerende, trombocythæmmende medicin)
  • Skriftligt informeret samtykke

Ekskluderingskriterier:

  • Patienter og deres familier er ikke i stand til at betjene smartphones
  • At have andre sygdomme, der forstyrrer klinisk opfølgningsvurdering (såsom kræft, demens, alvorlig psykisk sygdom osv.)
  • Den forventede levetid er mindre end 12 måneder
  • Patienter, der lever i fravær af netværksforhold

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: conventional care group
Patients are managed according to the conventional methods after enrollment.
Adfærdsmæssigt: conventional care
Patients in conventional care group will receive standardized education based on ASA/AHA 2021 guidelines prior to discharge,2 delivered verbally by a certified Brain-Heart Health Manager (BHHM) and supplemented with an expert-reviewed booklet. Content will cover medication adherence, risk factor control, stroke recognition, emergency response, and follow-up plans. A contact number will be provided for post-discharge support. A baseline archive will document demographics, lifestyle, and cardiovascular risk factors.
Eksperimentel: Social network-based intervention group
Patients are managed according to to the integrated digital platform
Adfærdsmæssigt: Social network-based intervention
Participants in Social network-based intervention group are onboard to the integrated digital platform. BHHMs facilitate the activation of the digital interface via a unique QR code, assist in the creation of a comprehensive electronic health record (EHR), and guide participants through an interactive tutorial to ensure technical proficiency in data entry and communication features.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Good Medication Adherence to all guideline-recommended vascular prevention medications at 12 months post-discharge
Tidsramme: 12 months post-discharge

Adherence is assessed using self-reported data, with participants asked to indicate the number of days they missed taking a dose for each medication class during the preceding 30 days. This evaluation is conducted separately for each of the five evidence-based secondary prevention drug classes: antihypertensives, hypoglycemics, lipid-lowering agents, anticoagulants, and antiplatelets. Good adherence for each class is defined as taking the prescribed medication on more than 24 days out of the previous 30 days (corresponding to an adherence rate >80%). To meet the primary endpoint, a participant must achieve this >80% adherence threshold simultaneously across all five medication classes at the 12-month follow-up.

Any self-directed cessation or adjustment of the regimen without medical consultation is categorized as non-adherence. Conversely, patients who cease or adjust their medications according to medical advice will be considered adherent. For those who adjust their medications base
12 months post-discharge

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of good medication adherence to stroke prevention drugs post-discharge
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Morisky-8 Medication Adherence Scale [MMAS-8]. Good adherence is defined as an MMAS-8 score greater than 6.The lowest score is 0, and the highest score is 8. A higher score indicates better adherence.
1 month, 3 months, 6 months and 12 months post-discharge
Risk factor control, including blood glucose(mmol/L), blood pressure(mmHg), lipid profile(mmol/L), body mass index (BMI) (kg/m ^ 2), waist circumference(cm), hip circumference(cm), and smoking status post-discharge.
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge

The method of measurement is as follows:

Blood lipids(mmol/L): fasting blood sampling measurement Blood glucose(mmol/L): fasting fingertip blood glucose Blood pressure(mmHg): using a sphygmomanometer to measure BMI (kg/m ^ 2): weight(kg) / height (m ^ 2) Waist circumference(cm), Hip circumference(cm), Smoking: Patient self-report
1 month, 3 months, 6 months and 12 months post-discharge
Health-related quality of life (HRQoL)
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L),including visual analog scale (score range of 0-100, higher score indicates better health status) and utility score (score range of[ -0.391,1], higher score indicates better quality of life for patients)
1 month, 3 months, 6 months and 12 months post-discharge
Anxiety symptom severity
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
assessed using the 7-item Generalized Anxiety Disorder Scale (GAD-7),the score range is 0-21 points, with higher scores indicating greater levels of anxiety.
1 month, 3 months, 6 months and 12 months post-discharge
Depressive symptom severity
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the 9-item Patient Health Questionnaire (PHQ-9),the score range is 0-27 points, with higher scores indicating more severe depression.
1 month, 3 months, 6 months and 12 months post-discharge
Stroke prevention knowledge scores
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Stroke Prevention Knowledge Questionnaire,the score range is 0-36 points, with higher scores indicating better mastery of stroke related knowledge.
1 month, 3 months, 6 months and 12 months post-discharge
Personal motivation for stroke prevention
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Stroke Attitude Questionnaire,the total score is the sum of 16 items, and the higher the score, the better the cognitive attitude.
1 month, 3 months, 6 months and 12 months post-discharge
Perceived social support
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Perceived Social Support Scale (PSSS),there are a total of 12 items, with each item assigned a score of 1-7, for a total score of 12-84. The higher the score, the higher the individual's level of social support.
1 month, 3 months, 6 months and 12 months post-discharge
Stroke prevention-related health behavior scores
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Stroke Prevention Health Behavior Scale,the scale consists of 25 items and uses the Likert 4-point scoring method. The higher the total score, the higher the level of healthy behavior.
1 month, 3 months, 6 months and 12 months post-discharge
Self-efficacy for chronic disease management
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Chronic Disease Self-Efficacy Scale,the scale consists of 6 items, with each item rated on a scale of 1-10. The average score is taken, and the higher the average score, the stronger the self-efficacy.
1 month, 3 months, 6 months and 12 months post-discharge
Intentions regarding prehospital delay in stroke emergency care
Tidsramme: 1 month, 3 months, 6 months and 12 months post-discharge
Assessed using the Prehospital Delay Behavior Intention Scale for Stroke,the scale consists of 27 items and uses the Likert 5-point scoring method, with a score range of 27-135 points. The higher the score, the stronger the intention and likelihood of delaying medical treatment.
1 month, 3 months, 6 months and 12 months post-discharge
Incidence of major adverse cerebrovascular and cardiovascular events (MACCE)
Tidsramme: 1month, 3months, 6months and 12-months post-discharge
Including stroke, acute coronary syndrome, and vascular death
1month, 3months, 6months and 12-months post-discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Changhai Hospital

Efterforskere

  • Studieleder: Zhang lingjuan, Changhai Hospital Affiliated to Naval Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. juli 2023

Primær færdiggørelse (Faktiske)

30. april 2025

Studieafslutning (Faktiske)

30. april 2025

Datoer for studieregistrering

Først indsendt

14. april 2023

Først indsendt, der opfyldte QC-kriterier

25. juli 2023

Først opslået (Faktiske)

27. juli 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COMPLIANCE-MT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual, de-identified participant data used in these analyses will be shared by request from any qualified investigator following approval of a protocol and signed data access agreement via both the trial steering committee.

IPD-delingstidsramme

Data sharing will be available from 12 months after the publication of the main results.

IPD-delingsadgangskriterier

1.The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2.The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3.Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4.Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5.The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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