- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03951168
Health Education for Diabetes Mellitus (hefdm)
Study on Standardized Management Model of Health Education for Diabetes Mellitus
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The aim was to develop a standardized patient education model reflecting the core educational elements recommended by Chinese diabetes society guideline, which could be delivered by nurses to hospitalized diabetes patients, and which could be easily scaled-up and implemented in China tier 3 hospital setting.
Management mode of standardized diabetes mellitus health education in intervention group.The control group carries on the routine diabetes mellitus health education management. In intervention group , All participants received Management mode of standardized diabetes mellitus health education.The standardized patient education included one-week personalized education on diabetes knowledge, diet and excise, glucose monitoring and hypoglycemia self-management and others during the hospitalization period. After discharge, patients were followed through the phone call at 2and 4 weeks. Follow-up of diabetic education outpatients at 12 and 24 weeks after discharge. The education nurse gave recommendations according to patent's problem during the follow-up. Full-time education nurses carry on education according to diabetes mellitus health education path table. In routine, After hospitalization, the responsible nurses interspersed with diabetes health education during the hospitalization. The health education is mainly about the problems observed by the responsible nurses and the problems raised by the patients. The patients were followed up by telephone 2 weeks after discharge.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710061
- First Affiliated Hospital of Xi'an Jiaotong University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes patients with World Health Organization(WHO) diagnosis (1999);
- HbA1c ≥ 7.5%;
- history of diabetes < 2 years;
- age from 18 to 70 years;
- having the ability of autonomous behavior, informed consent and voluntary participation in the study.
Exclusion Criteria:
- type 1 diabetes mellitus, gestational diabetes mellitus and other special types of diabetes;
- severe acute and chronic diseases, severe psychological failure, lung failure, tumor, etc.
- is participating in other researchers.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Routine Management
The patients were divided into routine diabetic health education management model group.
Patients who meet the criteria for admission and discharge.
|
Routine Management Model of Health Education for diabetes Patient will receive the Routine Management Model of Health Education for Diabetes.
After the patient was admitted to hospital, the responsible nurse carried on the diabetes health education for the patient.
There are no regulations on the path and time of education.
Interspersed with diabetes health education at work.
Follow up 2 weeks with phone call after discharge.
This is the current clinical model in hospital.
|
Eksperimentell: Standardized Management
The patients were divided into standardized diabetes health education management model group.
Patients who meet the criteria for admission and discharge.
|
Standardized Management Model of Health Education for Diabetes The patients were educated by full-time diabetic education nurses according to diabetes education path.
Including diabetes diet, exercise, drugs, hypoglycemia, diabetic foot, and so on.
Telephone follow-up was performed at 2 weeks and 4 weeks after discharge and 12 and 24 weeks follow-up in diabetes education clinic.
Develop telephone follow-up standardized content and implement telephone follow-up according to standardized content.Full-time education nurses carry on education according to diabetes mellitus health education path table.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Diabetes knowledge questionnaire ( DKQ)
Tidsramme: after 6 months
|
The DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy, clarity and content equivalence by conducting forward and back translations to verify translation equivalence. DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy,clarity and content equivalence by conducting forward and back translations to verify translation equivalence. |
after 6 months
|
Summary of Diabetes Self-Care Activities-6 (SDSCA-6)
Tidsramme: after 6 months
|
Evaluation the patient self management skill
|
after 6 months
|
Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)
Tidsramme: after 6 months
|
Evaluation the patient empowerment
|
after 6 months
|
Diabetes Specific Quality of Life
Tidsramme: after 6 months
|
Evaluation the patient quality of life
|
after 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HbA1c
Tidsramme: after 6 months
|
the patient'S blood glucose level
|
after 6 months
|
Fasting glucose
Tidsramme: after 6 months
|
the patient'S blood glucose level
|
after 6 months
|
2h postprandial glucose
Tidsramme: after 6 months
|
the patient'S blood glucose level
|
after 6 months
|
blood pressure
Tidsramme: after 6 months
|
the patient 'S blood pressure
|
after 6 months
|
Total Cholesterol
Tidsramme: after 6 months
|
the patient'S Total Cholesterol
|
after 6 months
|
LDL-C
Tidsramme: after 6 months
|
he patient'S LDL-C
|
after 6 months
|
HDL-C
Tidsramme: after 6 months
|
he patient'S HDL-C
|
after 6 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Meng Li, First Affiliated Hospital of Xi'an JiaoTong Univerisity
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018KRM115
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Sukkersyke
-
Medical College of WisconsinMedical University of South CarolinaFullførtSukkersyke | Type 2 diabetes mellitus | Voksendiabetes mellitus | Ikke-insulinavhengig diabetes mellitus | Ikke-insulinavhengig diabetes mellitus, type IIForente stater
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.FullførtDiabetes mellitus, type 1 | Type 1 diabetes | Diabetes type 1 | Type 1 diabetes mellitus | Autoimmun diabetes | Diabetes mellitus, insulinavhengig | Juvenil-Debut Diabetes | Diabetes, autoimmun | Insulinavhengig diabetes mellitus 1 | Diabetes mellitus, insulinavhengig, 1 | Diabetes mellitus, sprø | Diabetes mellitus... og andre forholdForente stater
-
SanofiFullførtType 1 Diabetes Mellitus-Type 2 Diabetes MellitusUngarn, Den russiske føderasjonen, Tyskland, Polen, Japan, Forente stater, Finland
-
Meir Medical CenterFullførtDiabetes mellitus type 2 | Diabetes mellitus, ikke-insulinavhengig | Diabetes mellitus, om oral hypoglykemisk behandling | Voksen type diabetes mellitusIsrael
-
Peking Union Medical College HospitalUkjentType 2 diabetes mellitus | Type 1 diabetes mellitus | Svangerskapsdiabetes mellitus | Pankreatogen diabetes mellitus | Pregestasjonell diabetes mellitus | Diabetespasienter i perioperativ periodeKina
-
Guang NingRekrutteringType 2 diabetes mellitus | Type 1 diabetes mellitus | Monogenetisk diabetes | Pankreatogen diabetes | Legemiddelindusert diabetes mellitus | Andre former for diabetes mellitusKina
-
Hoffmann-La RocheRoche DiagnosticsFullførtDiabetes mellitus type 2, diabetes mellitus type 1Tyskland
-
University of California, San FranciscoJuvenile Diabetes Research FoundationFullførtType 1 diabetes mellitus | Diabetes mellitus, type I | Insulinavhengig diabetes mellitus 1 | Diabetes mellitus, insulinavhengig, 1 | IDDMForente stater, Australia
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)FullførtDiabetes mellitus, type 2 | Diabetes mellitus, type II | Diabetes mellitus, voksendebut | Diabetes mellitus, ikke-insulinavhengig | Diabetes mellitus, ikke-insulinavhengigForente stater
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and...Aktiv, ikke rekrutterendeDiabetes mellitus, type 2 | Diabetes mellitus, type II | Diabetes mellitus, voksendebut | Diabetes mellitus, ikke-insulinavhengig | Diabetes mellitus, ikke-insulinavhengigForente stater
Kliniske studier på Routine Management
-
University of ChicagoRekrutteringHjertefeil | Høyre ventrikkel dysfunksjon | Høyre ventrikkelsviktForente stater
-
VA Pacific Islands Health Care SystemUnited States Department of Defense; Charles River AnalyticsFullførtSinne | Stresslidelser, posttraumatiskForente stater
-
VA Office of Research and DevelopmentFullførtObstruktiv søvnapnéForente stater
-
University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Fullført
-
US Department of Veterans AffairsFullført
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI); American Lung Association og andre samarbeidspartnereAktiv, ikke rekrutterendeUnge voksne | Ukontrollert astmaForente stater
-
Analog Device, Inc.Orlando Health, Inc.Rekruttering
-
Liberating Technologies, Inc.Vivonics, Inc.FullførtAmputasjon | Protese | Protesebruker | Amputasjonsstump | Amputerte | Deformitet i nedre ekstremiteterForente stater
-
University of Illinois at Urbana-ChampaignUkjentMultippel skleroseForente stater
-
University of FloridaFullførtSmerte | Postoperativ smerte | Kirurgisk smerte | Nevrokirurgisk smerteForente stater