- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00182026
Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Diabetes mellitus (DM) is a common chronic disease that is rapidly rising in prevalence, affecting upwards of 35,000 adults in the Hamilton, Ontario region (population 400,000). The magnitude and growth of the problem and its serious health consequences suggest that:
- diabetes is now a major public health problem; and
- interventions at the community level are needed to mitigate its health impact.
During the last 5 years, Diabetes Hamilton was successfully piloted as a free community-based program available to anyone with diabetes. It promotes diabetes self-management, self-efficacy and awareness through the provision of generalized diabetes information (e.g. newsletters, workshops, forums, resource directories) to consumers, local physicians and other health professionals.
This trial will determine if supplementing Diabetes Hamilton with an automated tailored feedback system that:
- provides information;
- generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
- copies this communication to the patient's designated physician;
- facilitates access to community resources; and
- provides a simple way for the patient to track changes in indicators of health can improve A1c and other diabetes care indicators more than Diabetes Hamilton alone.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes of 1 or more years duration
- Health insurance coverage within Ontario
- Ages 40 or older
- Registered in, or willing to register in Diabetes Hamilton
- Able to read and understand English and provide informed consent in English
- Have home access to either mail, e-mail or the internet
- Have a baseline A1c >= 7%
Exclusion Criteria:
- Current pregnancy
- Residence in an institution that provides diabetes care
- Cohabiting with study participant
- Residence outside the city of Hamilton
- Inability to read or understand English
- Inability/unwillingness to sign the informed consent or comply with protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
A1c
Tidsramme: 6 months and 1 year
|
6 months and 1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
diabetes-related self-care behaviours, drug use, clinical outcomes
Tidsramme: 6 months and 1 year
|
6 months and 1 year
|
|
diabetes-specific quality of life
Tidsramme: 1 year
|
1 year
|
|
incremental cost/quality-adjusted life-year [QALY]
Tidsramme: 6 months and 1 year
|
6 months and 1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hertzel C Gerstein, MD MSc FRCPC, McMaster University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MCT-68786
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