Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
Recruitment status was Active, not recruiting
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Purpose
The purpose of this study is to test whether providing personalized diabetes self-management recommendations and feedback improves blood sugar control more than providing generalized diabetes educational material alone.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: personal feedback report |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE |
- A1c [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
- diabetes-related self-care behaviours, drug use, clinical outcomes [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
- diabetes-specific quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- incremental cost/quality-adjusted life-year [QALY] [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
-
Behavioral: personal feedback report
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Canada, Ontario | |
| McMaster University | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Principal Investigator: | Hertzel C Gerstein, MD MSc FRCPC | McMaster University |
More Information
No publications provided by McMaster University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hertzel Gerstein, Professor, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00182026 History of Changes |
| Other Study ID Numbers: | MCT-68786 |
| Study First Received: | September 9, 2005 |
| Last Updated: | October 7, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
diabetes community intervention self-management prevention |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013