Diabetes Mellitus, Type 2NCT00906919
The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes
A study testing Regular diabetes patient education and Augmented diabetes patient education in people with Diabetes Mellitus, Type 2, run by University of Victoria at 1 site in Canada.
Trial summary
The goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally-led diabetes patient education in comparison to regular professionally-led diabetes patient education only. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Regular diabetes patient education and Augmented diabetes patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2004to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with type 2 diabetes
Who cannot join
- cognitive impairment
- unable to speak English
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Victoria - Centre on Aging (Ladner Office), Suite 210, 4907 Chisholm Street
Delta, British Columbia, V4K 2K6
About this study
The goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally-led diabetes patient education in comparison to regular professionally-led diabetes patient education only.
Read the detailed description
In the current health care environment, it is unacceptable for patient education programs to merely provide information. Rather, educational programs must concentrate on behavior change and on supporting patients to become more confident and motivated in participating in managing their health. Persons with type 2 diabetes attending a Diabetes Education Centre will be assigned to either a group that receives regular professionally-led diabetes patient education (control group) or to to a group that receives regular professionally-led diabetes patient education augmented by lay-led self-management education i.e., the Stanford six-session Chronic Disease Self-Management Program (experimental group). Data will be collected at two points in time (0 and 6 months). Outcome measures will show if participants who receive self-management training in addition to regular patient education are able to:manage their diabetes more effectively; engage in the specific behaviors that keep the condition from worsening; achieve more control over their condition; and use the health care system more effectively.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Regular diabetes patient education, Augmented diabetes patient education
- Keywords
- self-efficacy, health behavior, patient education, health education
- Medical subject headings
- Diabetes Mellitus, Type 2, Health Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular diabetes patient educationBehavioural
Professionally-led diabetes patient education delivered by health professionals over a two day period
Augmented diabetes patient educationBehavioural
Professionally-led diabetes patient education led by nurse and dietitian over a two day period augmented by participation in the Stanford Chronic Disease Self-Management Program. This program takes place for 2 1/2 hours per week for six consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Regular diabetes patient education | Active comparator | Regular professionally-led diabetes patient education Receives: Behavioral: Regular diabetes patient education |
| Augmented Diabetes Patient Education | Experimental | Regular professionally-led diabetes patient education augmented by participation in the Stanford Chronic Disease Self-Management Program Receives: Behavioral: Augmented diabetes patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C
Measured: 6 months
Secondary outcomes (4)
Self-management behaviors
Measured: 6 months
Self-efficacy levels
Measured: 6 months
Health status
Measured: 6 months
Cholesterol levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2004
- Primary completionMar 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Foundation
- Investigators
- Patrick T McGowan, PhD, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906919
- Sponsor's protocol ID
- BCM03-0095
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00906919
- Acronym / sponsor ID
- BCM03-0095
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- self-efficacy, health behavior, patient education, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Collaborators
- Vancouver Foundation
- Study start
- Apr 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally-led diabetes patient education in comparison to regular professionally-led diabetes patient education only.
Detailed description
In the current health care environment, it is unacceptable for patient education programs to merely provide information. Rather, educational programs must concentrate on behavior change and on supporting patients to become more confident and motivated in participating in managing their health. Persons with type 2 diabetes attending a Diabetes Education Centre will be assigned to either a group that receives regular professionally-led diabetes patient education (control group) or to to a group that receives regular professionally-led diabetes patient education augmented by lay-led self-management education i.e., the Stanford six-session Chronic Disease Self-Management Program (experimental group). Data will be collected at two points in time (0 and 6 months). Outcome measures will show if participants who receive self-management training in addition to regular patient education are able to:manage their diabetes more effectively; engage in the specific behaviors that keep the condition from worsening; achieve more control over their condition; and use the health care system more effectively.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular diabetes patient education | Active comparator | Behavioral: Regular diabetes patient educationRegular professionally-led diabetes patient education |
| Augmented Diabetes Patient Education | Experimental | Behavioral: Augmented diabetes patient educationRegular professionally-led diabetes patient education augmented by participation in the Stanford Chronic Disease Self-Management Program |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults with type 2 diabetes
Key exclusion criteria (2 listed)
- cognitive impairment
- unable to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular diabetes patient educationProfessionally-led diabetes patient education delivered by health professionals over a two day period | Behavioural | Regular diabetes patient education |
| Augmented diabetes patient educationProfessionally-led diabetes patient education led by nurse and dietitian over a two day period augmented by participation in the Stanford Chronic Disease Self-Management Program. This program takes place for 2 1/2 hours per week for six consecutive weeks. | Behavioural | Augmented Diabetes Patient Education |
Primary outcome
A1C
Time frame: 6 months
4 secondary outcomes
Self-management behaviors
Time frame: 6 months
Self-efficacy levels
Time frame: 6 months
Health status
Time frame: 6 months
Cholesterol levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick T McGowan, PhD principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular diabetes patient education and Augmented diabetes patient education in people with Diabetes Mellitus, Type 2, run by University of Victoria at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1C (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2009.