- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04737499
Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)
2. februar 2021 oppdatert av: Claremont Graduate University
Implementation and Evaluation of A Culturally Tailored Diabetes Self-Management Program for Chinese Americans
The project aimed to evaluate the implementation process and efficacy of a culturally tailored Diabetes Self-Management and Education (DSME) program with mobile health (mHealth) technology integration, entitled Culturally Appropriate Strategies for Chinese Americans with Diabetes (CASCADe), among Chinese American adults with Type 2 diabetes.
Studieoversikt
Detaljert beskrivelse
The CASCADe program includes 1) a home visit for training of monitoring devices use, WeChat app and acquiring family support, 2) 8 weekly education sessions with a combined format of group class, games, food demonstration, group exercise, video and discussion, 3) WeChat follow-up on education tips, monitoring data summary, and group discussion.
The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels.
WeChat app was used to facilitate behavioral self-monitoring by providing daily messages related to diabetes education curriculum, weekly summary reports on monitoring data as well as reinforcement messages and group discussion on readings and monitoring results implication.
A single group pre-post-test design was adopted to evaluate changes of primary (HbA1c) and secondary (Self-efficacy, quality of life and stress coping) outcomes assessed at pre and post of intervention.
Engagement and adherence in education sessions and self-monitoring system, and satisfaction with the content and delivery of intervention were also evaluated at the end of the study.
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Claremont, California, Forente stater, 91711
- Clarement Graduate University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- have been diagnosed with Type 2 diabetes
- having been managing diabetes with diet, oral hypoglycemic agents or insulin, or both
- confirmed HbA1c level >=6.5% and <10%
- 21-75 years old
- residents of San Gabriel Valley
- speak and understand of Mandarin
- willing to use the smartphone-based monitoring devices provided by the project.
Exclusion Criteria:
- unable or unwilling to give informed consent
- plan to move out of the area within the 1-year participation study period
- are or plan to be pregnant or breastfeeding in the next 12 months
- have a condition that inhibits movement (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)
- have major physical disability or condition that prevents them from participating in person.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: CASCADe Intervention
Intervention consisted of eight weekly sessions of health education and diabetes management.
Topics covered include recognition of diabetes and its complications, risk factors, nutrition knowledge, dietary practices, exercise, behavioral self-monitoring, medication adherence, and stress management.
Intervention also included a home visit for training of monitoring devices use, WeChat app and acquiring family support, and weekly WeChat follow-up on education tips, monitoring data summary, and group discussion.
The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels.
|
Culturally tailored diabetes self-management and education sessions with mHealth integration
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of Concentration of HbA1c
Tidsramme: Change from baseline HbA1c at 3 months
|
HbA1c was assessed using the testing kit of A1C Now+ with a finger prick of blood by trained data collector.
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Change from baseline HbA1c at 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change of Score of Self-efficacy
Tidsramme: Change from baseline Self-efficacy score at 3 months
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Chinese version of diabetes self-management self-efficacy scale included 20 items with likert-like response scale of 1-5 and minimum score of 20 and maximum score of 100.
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Change from baseline Self-efficacy score at 3 months
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Change of Score of Quality of life
Tidsramme: Change from baseline Quality of life score at 3 months
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Chinese version of diabetes quality of life scale included 15 items with likert-like response scale of 1-5, and minimum score of 15 and maximum score of 75. .
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Change from baseline Quality of life score at 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. juli 2016
Primær fullføring (Faktiske)
15. februar 2018
Studiet fullført (Faktiske)
20. mars 2018
Datoer for studieregistrering
Først innsendt
28. januar 2021
Først innsendt som oppfylte QC-kriteriene
2. februar 2021
Først lagt ut (Faktiske)
4. februar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. februar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CGU IRB#2522
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified datasets with individual participant data will be provided by the Principal Investigator upon request.
All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the research investigating team.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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