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Udnyttelse af videoer og sundhedsarbejdere i lokalsamfundet til at adressere sociale sundhedsdeterminanter hos immigranter (LINK-IT)

11. september 2026 opdateret af: NYU Langone Health

LINK-IT: Udnyttelse af videoer og sundhedsarbejdere i lokalsamfundet til at adressere sociale sundhedsdeterminanter hos immigranter

Det overordnede mål med denne undersøgelse er at undersøge effektiviteten af ​​den videobaserede Diabetes Self-Management Education and Support (DSMES) (herefter VIDEO) eller den videobaserede DSMES+community health worker (CHW) intervention (herefter VIDEO+CHW) ), sammenlignet med en ventelistekontrolgruppe (herefter benævnt KONTROL) for at forbedre glykæmisk kontrol blandt kinesiske immigranter med ukontrolleret type 2-diabetes i NYC.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Deltagerne vil blive randomiseret med ligelig fordeling til en af ​​de 3 grupper. VIDEO-gruppen vil modtage 1 DSMES kort video/uge i 24 uger leveret via sms. VIDEO+CHW-gruppen vil modtage de samme DSMES-videoer plus ugentlige supportopkald fra en CHW i 24 uger. CHW vil vurdere deltagernes sociale determinanter for sundhed (SDOH) barrierer for type 2-diabetesbehandling og knytte dem til tilgængelige ressourcer i samfundet. KONTROL-gruppen vil fortsat modtage deres sædvanlige pleje, og ved afslutningen af ​​undersøgelsen vil de modtage DSMES-videoer.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

540

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • NYU Langone Health

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:

  • selvidentifikation som kinesisk immigrant;
  • være mellem 18-70 år;
  • have en diagnose af type 2-diabetes (T2D) i journalen;
  • har haft en aftale med en læge til rutinemæssig T2D-behandling inden for de seneste 12 måneder;
  • har en seneste HbA1c på mindst 8 %;
  • være villig til at modtage korte videoer vedrørende T2D management; og
  • besidde en smartphone eller, hvis de ikke har en, være villige og i stand til at bruge en studiesmartphone.

Ekskluderingskriterier:

  • ude af stand til eller uvillig til at give informeret samtykke;
  • ude af stand til at deltage meningsfuldt i interventionen (f.eks. ukorrigeret syns- og hørenedsættelse);
  • uvillig til at acceptere randomiseringsopgave;
  • er gravid, planlægger at blive gravid inden for de næste 6 måneder eller bliver gravid under undersøgelsen; eller
  • ammer (de kan f.eks. have potentielle diætrestriktioner).

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VIDEO
Deltagere, der er tildelt VIDEO-armen, vil modtage én kort Diabetes Self-Management Education and Support (DSMES) video om ugen i 24 uger. Videoerne vil blive leveret via sms.
Adfærdsmæssigt: Videobaseret diabetes selvledelsesuddannelse og -støtte (DSMES)
DSMES-videoerne giver deltagerne vigtig diabetesuddannelse og giver dem mulighed for at blive en aktiveret patient på det individuelle plan.
Eksperimentel: VIDEO+CHW
Deltagere, der er tilknyttet VIDEO+CHW-armen, vil modtage én kort DSMES-video om ugen, ud over ugentlige støtteopkald fra en sundhedsarbejder i lokalsamfundet (CHW) i 24 uger. DSMES-videoerne vil blive leveret via sms.
Adfærdsmæssigt: Videobaseret diabetes selvledelsesuddannelse og -støtte (DSMES)
DSMES-videoerne giver deltagerne vigtig diabetesuddannelse og giver dem mulighed for at blive en aktiveret patient på det individuelle plan.
Adfærdsmæssigt: Community Health Worker (CHW) Support
CHW'er vil vurdere deltagernes sociale determinanter for sundhed (SDOH) barrierer for type 2-diabetesbehandling og knytte dem til tilgængelige ressourcer i samfundet.
Ingen indgriben: CONTROL
Participants assigned to the CONTROL group will continue to receive usual care. At the end of the study, they will receive DSMES videos.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Hæmoglobin A1c (HbA1c) niveauer
Tidsramme: Baseline
Baseline
Hæmoglobin A1c (HbA1c) niveauer
Tidsramme: Måned 6
Måned 6
Hæmoglobin A1c (HbA1c) niveauer
Tidsramme: Måned 12
Måned 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
International Physical Activity Questionnaire (IPAQ) kortversionsresultat
Tidsramme: Baseline

Selvevaluering giver et estimat over antallet af minutter om ugen, deltagere engagerer sig i tre kategorier af fysisk aktivitet: Kraftig aktivitet, moderat aktivitet og gåaktivitet. Resultater er udtrykt i metabolisk ækvivalent (MET) minutter pr. uge. MET-minutter repræsenterer mængden af ​​energi, der bruges på at udføre fysisk aktivitet. Formlen for beregning af MET er som følger: 8(kraftig aktivitet)(minutter) + 4 (moderat aktivitet)(minutter) +3,3 (gåaktivitet) (minutter) = MET.

Højere MET-score indikerer højere ugentlige niveauer af fysisk aktivitet.
Baseline
International Physical Activity Questionnaire (IPAQ) kortversionsresultat
Tidsramme: Måned 6

Selvevaluering giver et estimat over antallet af minutter om ugen, deltagere engagerer sig i tre kategorier af fysisk aktivitet: Kraftig aktivitet, moderat aktivitet og gåaktivitet. Resultater er udtrykt i metabolisk ækvivalent (MET) minutter pr. uge. MET-minutter repræsenterer mængden af ​​energi, der bruges på at udføre fysisk aktivitet. Formlen for beregning af MET er som følger: 8(kraftig aktivitet)(minutter) + 4 (moderat aktivitet)(minutter) +3,3 (gåaktivitet) (minutter) = MET.

Højere MET-score indikerer højere ugentlige niveauer af fysisk aktivitet.
Måned 6
International Physical Activity Questionnaire (IPAQ) kortversionsresultat
Tidsramme: Måned 12

Selvevaluering giver et estimat over antallet af minutter om ugen, deltagere engagerer sig i tre kategorier af fysisk aktivitet: Kraftig aktivitet, moderat aktivitet og gåaktivitet. Resultater er udtrykt i metabolisk ækvivalent (MET) minutter pr. uge. MET-minutter repræsenterer mængden af ​​energi, der bruges på at udføre fysisk aktivitet. Formlen for beregning af MET er som følger: 8(kraftig aktivitet)(minutter) + 4 (moderat aktivitet)(minutter) +3,3 (gåaktivitet) (minutter) = MET.

Højere MET-score indikerer højere ugentlige niveauer af fysisk aktivitet.
Måned 12
Stanford Self-Efficacy for Diabetes Scale Score
Tidsramme: Baseline
8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
Baseline
Stanford Self-Efficacy for Diabetes Scale Score
Tidsramme: Month 6
8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
Month 6
Stanford Self-Efficacy for Diabetes Scale Score
Tidsramme: Month 12
8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
Month 12
Starting the Conversation (STC) Diet Scale Score
Tidsramme: Baseline
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
Baseline
Starting the Conversation (STC) Diet Scale Score
Tidsramme: Month 6
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
Month 6
Starting the Conversation (STC) Diet Scale Score
Tidsramme: Month 12
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
Month 12
Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
Tidsramme: Baseline
ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.
Baseline
Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
Tidsramme: Month 6
ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.
Month 6
Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
Tidsramme: Month 12
ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.
Month 12
Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales
Tidsramme: Baseline
8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.
Baseline
Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales
Tidsramme: Month 6
8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.
Month 6
Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales
Tidsramme: Month 12
8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.
Month 12
Diabetes-Related Distress
Tidsramme: Baseline
Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes. Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem"). The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.
Baseline
Diabetes-Related Distress
Tidsramme: Month 6
Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes. Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem"). The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.
Month 6
Diabetes-Related Distress
Tidsramme: Month 12
Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes. Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem"). The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.
Month 12
SDOH Barriers
Tidsramme: Baseline
The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.
Baseline
SDOH Barriers
Tidsramme: Month 6
The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.
Month 6
SDOH Barriers
Tidsramme: Month 12
The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.
Month 12
Health-Related Social Needs
Tidsramme: Baseline
Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool. The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability. These domains identify social needs that may be addressed through clinical and community-based services. Each domain includes its own set of indicators. Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables. For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.
Baseline
Health-Related Social Needs
Tidsramme: Month 6
Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool. The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability. These domains identify social needs that may be addressed through clinical and community-based services. Each domain includes its own set of indicators. Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables. For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.
Month 6
Health-Related Social Needs
Tidsramme: Month 12
Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool. The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability. These domains identify social needs that may be addressed through clinical and community-based services. Each domain includes its own set of indicators. Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables. For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.
Month 12
Cognitive Function
Tidsramme: Baseline
Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment. Total scores range from 0 to 15, with higher scores indicating better cognitive function. A score below 11 may indicate cognitive impairment and warrant further evaluation.
Baseline
Cognitive Function
Tidsramme: Month 6
Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment. Total scores range from 0 to 15, with higher scores indicating better cognitive function. A score below 11 may indicate cognitive impairment and warrant further evaluation.
Month 6
Cognitive Function
Tidsramme: Month 12
Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment. Total scores range from 0 to 15, with higher scores indicating better cognitive function. A score below 11 may indicate cognitive impairment and warrant further evaluation.
Month 12

Samarbejdspartnere og efterforskere

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

Sponsor

NYU Langone Health

Samarbejdspartnere

National Institute on Minority Health and Health Disparities (NIMHD)

Efterforskere

  • Ledende efterforsker: Lu Hu, PhD, NYU Langone Health

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)

29. december 2024

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

13. marts 2024

Først indsendt, der opfyldte QC-kriterier

13. marts 2024

Først opslået (Faktiske)

20. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 23-01274

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De afidentificerede deltagerdata fra det endelige forskningsdatasæt, der bruges i det publicerede manuskript, vil blive delt efter rimelig anmodning begyndende 9 måneder og slutter 36 måneder efter artiklens offentliggørelse eller som krævet af en betingelse for priser og aftaler, der understøtter forskningen, forudsat at investigatoren, der foreslår at bruge dataene udfører en databrugsaftale med NYU Langone Health. Anmodninger kan rettes til: Lu.hu@nyulangone.org. Protokollen og den statistiske analyseplan vil blive gjort tilgængelige på Clinicaltrials.gov kun som krævet af føderal lovgivning eller som en betingelse for priser og aftaler, der understøtter forskningen.

IPD-delingstidsramme

Begyndende 9 måneder og slutter 36 måneder efter artiklens udgivelse eller som krævet af en betingelse for priser og aftaler, der understøtter forskningen.

IPD-delingsadgangskriterier

Efterforskeren, der foreslog at bruge dataene, vil få adgang efter rimelig anmodning. Anmodninger skal rettes til Lu.hu@nyulangone.org. For at få adgang skal dataanmodere underskrive en dataadgangsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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