- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03334370
Evaluation of Quality of Care - Shared-Care Programme, HA (QoC SCP)
Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the shared-care (SC) programme to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.
The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the SC programme is achieved. Each SC participating clinic and private medical practitioner (PMP) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the programme will be included in the evaluation on the process and outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records.
Main Outcome Measures: The primary outcomes are the proportion of participants who received the criterion process of care and achieved a HbA1c level <7.5%.
Data Analysis: Descriptive statistics on proportions of clinics or subjects meeting the quality of care criteria will be calculated. The outcomes of SC patients will be compared at 6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between SC patients and control group will be compared by independent sample t-test or Chi-square test.
Hypothesis: The QOC of the SC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. The results of this study will provide empirical evidence on whether the HA's SC programme can achieve equivalent QOC as the usual HA care for diabetes mellitus (DM) patients. The information will be used to guide service planning and policy decision making.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Hksar
-
Hong Kong, Hksar, Hongkong
- The University of Hong Kong
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients with diabetes mellitus who have received care at the specialist outpatient clinic (SOPC)for at least 2 years, stratified to be of low risk and have normal renal function as defined by the plasma creatinine level.
Exclusion Criteria:
- Patients will be excluded if they are stratified to be at high cardiovascular risk or are suffering end stage renal failure, on dialysis or after transplantation, or on insulin, or do not give consent to be transferred.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
DM subjects in Hong Kong
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change of the proportion of clinics that have satisfied each of the structure criteria.
Tijdsspanne: December, 2010; December, 2011; December, 2012; December, 2013; December, 2014
|
December, 2010; December, 2011; December, 2012; December, 2013; December, 2014
|
|
Change of the proportion of patients who have received with the SC criterion process of care.
Tijdsspanne: June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
|
June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
|
|
Change of the proportion of patients who have achieved a HbA1c <7.5%.
Tijdsspanne: June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
|
June, 2011; December, 2011; December, 2012; December, 2013; December, 2014
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Low-density lipoprotein (LDL)
Tijdsspanne: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
|
Blood pressure (BP)
Tijdsspanne: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
|
Body mass index (BMI)
Tijdsspanne: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
|
Cardiovascular complications
Tijdsspanne: Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
Baseline, 6, 12, 24, 36 and 48 months after enrollment.
|
|
Patient reported outcomes (PRO) measured by the change in Short Form-12 version 2 (SF-12v2) scores at 6 months.
Tijdsspanne: Baseline and 6 months after the first administration of questionnaire.
|
Baseline and 6 months after the first administration of questionnaire.
|
|
Patient reported outcomes (PRO) measured by the change in the Patient Enablement Instrument (PEI) scores at 6 months.
Tijdsspanne: Baseline and 6 months after the first administration of questionnaire.
|
Baseline and 6 months after the first administration of questionnaire.
|
|
Patient reported outcomes (PRO) measured by the change in the Global Rating Scale (GRS) at 6 months.
Tijdsspanne: Baseline and 6 months after the first administration of questionnaire.
|
Baseline and 6 months after the first administration of questionnaire.
|
|
Service utilization outcomes measured by General Outpatient Clinics (GOPC) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Tijdsspanne: Baseline, 12, 24, 36 and 48 months after enrollment
|
Baseline, 12, 24, 36 and 48 months after enrollment
|
|
Service utilization outcomes measured by specialist outpatient clinic (SOPC) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Tijdsspanne: Baseline, 12, 24, 36 and 48 months after enrollment
|
Baseline, 12, 24, 36 and 48 months after enrollment
|
|
Service utilization outcomes measured by accident & emergency (A&E) attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Tijdsspanne: Baseline, 12, 24, 36 and 48 months after enrollment
|
Baseline, 12, 24, 36 and 48 months after enrollment
|
|
Service utilization outcomes measured by hospital attendance rates at baseline and 12, 24, 36 and 48 months after enrollment.
Tijdsspanne: Baseline, 12, 24, 36 and 48 months after enrollment
|
Baseline, 12, 24, 36 and 48 months after enrollment
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HKCTR-1185
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Suikerziekte
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.VoltooidDiabetes mellitus, type 1 | Diabetes type 1 | Diabetestype1 | Diabetes mellitus type 1 | Auto-immuun diabetes | Diabetes Mellitus, insulineafhankelijk | Jeugddiabetes | Diabetes, auto-immuunziekte | Insulineafhankelijke diabetes mellitus 1 | Diabetes Mellitus, insulineafhankelijk, 1 | Diabetes Mellitus,... en andere voorwaardenVerenigde Staten
-
Guang NingWervingDiabetes mellitus type 2 | Diabetes mellitus type 1 | Monogene diabetes | Pancreatogene diabetes | Door medicijnen veroorzaakte diabetes mellitus | Andere vormen van diabetes mellitusChina
-
State University of New York at BuffaloMedical University of South CarolinaVoltooidSuikerziekte | Diabetes mellitus type 2 | Diabetes Mellitus bij volwassenen | Niet-insulineafhankelijke diabetes mellitus | Niet-insulineafhankelijke diabetes mellitus, type IIVerenigde Staten
-
SanofiVoltooidDiabetes mellitus type 1 - Diabetes mellitus type 2Hongarije, Russische Federatie, Duitsland, Polen, Japan, Verenigde Staten, Finland
-
Hoffmann-La RocheRoche DiagnosticsVoltooidDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Duitsland
-
Meir Medical CenterVoltooidDiabetes mellitus type 2 | Diabetes Mellitus, niet-insulineafhankelijk | Diabetes Mellitus, over orale hypoglycemische behandeling | Diabetes Mellitus bij volwassenenIsraël
-
Peking Union Medical College HospitalOnbekendDiabetes mellitus type 2 | Diabetes mellitus type 1 | Zwangerschapsdiabetes mellitus | Pancreatogene diabetes mellitus | Pregestationele diabetes mellitus | Diabetespatiënten in de perioperatieve periodeChina
-
University of Colorado, DenverMassachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of Chicago en andere medewerkersWervingSuikerziekte | Suikerziekte | Type 2 diabetes | Diabetes mellitus type 2 | Diabetes mellitus, type I | Diabetes mellitus type II | Diabetes Mellitus, insulineafhankelijk | Diabetes, auto-immuunziekte | Diabetes type 1 (T1D) | Diabetes type 2 op insuline | Diabetes, Type IIVerenigde Staten
-
Medtronic MiniMed, Inc.WervingDiabetes mellitus type 2 | Diabetes mellitus type 1Verenigde Staten, Australië, Nieuw-Zeeland
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)VoltooidDiabetes mellitus, type 2 | Diabetes mellitus, Type II | Diabetes Mellitus, aanvang op volwassen leeftijd | Diabetes Mellitus, niet-insulineafhankelijk | Diabetes Mellitus, niet-insuline-afhankelijkVerenigde Staten