Diabetes Mellitus, Type 2NCT00684086
English Diabetes Self-Management Program
A study testing Diabetes Self Management Program in people with Diabetes Mellitus, Type 2, run by Stanford University at 1 site in United States.
Trial summary
We propose a diabetes self-management program evaluation and dissemination project with three components. 1. A six-month randomized trial to evaluate the effect of a community-based small group Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic control and health care utilization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Self Management Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with prior diagnosis of type 2 Diabetes.
- Able to speak and comprehend English.
- Able to give and complete consent forms.
- Able to complete baseline questionnaire and 2-3 follow-up questionnaires either in writing or by telephone.
- Able to attend respective community meetings or allow study staff to collect the following metabolic test measures: provide 3 drops of blood for Hemoglobin A1c and cholesterol HDL test (administered by subject), blood pressure measure, height and weight measures.
- Able to attend the Peer-Led Community-Based Diabetes Self-Management Program workshops offered once a week for six weeks at a community site near subjects residence.
Who cannot join
- Individuals not diagnosed with type 2 diabetes.
- Individuals diagnosed with type 1 diabetes.
- Pregnant women, including those diagnosed with gestational diabetes.
- Individuals who have been in active treatment for cancer in the past yar.
- Individuals not able to speak or comprehend English.
- Individuals who are currently or have previously participated in a similar program or study.
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- Individuals that are not able to give consent or complete consent forms, and other study related forms such as questionnaires.
- Individuals who are not able and willing to provide metabolic test data.
- Individuals not able to attend the 6-week community classes in the target counties in California.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
We propose a diabetes self-management program evaluation and dissemination project with three components.
- A six-month randomized trial to evaluate the effect of a community-based small group Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic control and health care utilization of people with type 2 diabetes.
- A long-term (12 month) longitudinal evaluation of the same program.
- Two 5 day workshops to train others in California in how to lead and administer the program.
Read the detailed description
- Implement and evaluate in a 6-month randomized controlled evaluation an experimental self-management program for patients with type 2 diabetes. Outcomes for evaluating the intervention's impact include health status (health-related quality-of-life and metabolic control) and health care utilization. Mediating outcomes are health behaviors and self-efficacy.
- Evaluate the same program in a one year longitudinal study using the same outcomes.
- Disseminate the program to others in California by holding two five day workshops during which we will prepare the participants to both offer the program and to train others in their organization to offer the program.
This proposed evaluation will examine the following questions:
Hypothesis 1. People participating in the Diabetes Self-Management Program (SDSMP), when compared six months after baseline to randomized wait-list controls receiving usual care, will demonstrate:
- Improvements in health-related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health). Improvements in metabolic measures of health status (body mass index, hemoglobin A1c, total cholesterol/HDL ratio and blood pressure).
- Changes in utilization of health services, specifically, increases in outpatient visits to physicians and nurses, increases in the percentage of subjects having received an eye examination in the past year, increases in the number of times a health professional has examined subject's feet, and decreases in emergency room visits, hospitalizations, and hospital days.
- Improvements in beneficial self-management behaviors (aerobic exercise, communication with physicians, diet, self-monitoring of blood glucose and self-examination of the feet).
- Increases in perceived self-efficacy to manage diabetes.
Hypothesis 2. The changes in health related quality of life, metabolic status, health behaviors and health care utilization will be maintained for one year.
Hypothesis 3. Twelve to fifteen health care organizations in California will be interested in disseminating the program. This will be demonstrated by their willingness to send 2-3 persons each to a 5 day training which will allow their organization to replicate and perpetuate the program.
Hypothesis 4. 8-10 health care organizations in California will have offered at least two Diabetes Self-Management Programs to people with Type 2 diabetes one year following the above dissemination training. (It should be noted that this hypothesis can not be tested during the funded portion of the program. However, it our intent to contact all organizations participating in dissemination training one year following the training to determine what they have done with the program). The results of this follow-up will be reported to The Foundation.)
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes Self Management Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self Management ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1
symptoms of hypoglycemia
symptoms of hyperglycemia
self-monitoring of blood glucose
self-efficacy to manage diabetes
Secondary outcomes (7)
fatigue
physical discomfort
activity limitations
health distress
self-rated health
aerobic exercise
communication with physicians
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Kate R Lorig, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684086
- Sponsor's protocol ID
- 96943
- Other IDs
- 5312
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 26 May 2008
- Results posted
- No
Publications
Lorig K, Ritter PL, Villa FJ, Armas J. Community-based peer-led diabetes self-management: a randomized trial. Diabetes Educ. 2009 Jul-Aug;35(4):641-51. doi: 10.1177/0145721709335006. Epub 2009 Apr 30.
PubMed 19407333
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- English Diabetes Self-Management Program
- ClinicalTrials.gov ID
- NCT00684086
- Acronym / sponsor ID
- 96943
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 26 May 2008 (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.
We propose a diabetes self-management program evaluation and dissemination project with three components.
- A six-month randomized trial to evaluate the effect of a community-based small group Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic control and health care utilization of people with type 2 diabetes.
- A long-term (12 month) longitudinal evaluation of the same program.
- Two 5 day workshops to train others in California in how to lead and administer the program.
Detailed description
- Implement and evaluate in a 6-month randomized controlled evaluation an experimental self-management program for patients with type 2 diabetes. Outcomes for evaluating the intervention's impact include health status (health-related quality-of-life and metabolic control) and health care utilization. Mediating outcomes are health behaviors and self-efficacy.
- Evaluate the same program in a one year longitudinal study using the same outcomes.
- Disseminate the program to others in California by holding two five day workshops during which we will prepare the participants to both offer the program and to train others in their organization to offer the program.
This proposed evaluation will examine the following questions:
Hypothesis 1. People participating in the Diabetes Self-Management Program (SDSMP), when compared six months after baseline to randomized wait-list controls receiving usual care, will demonstrate:
- Improvements in health-related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health). Improvements in metabolic measures of health status (body mass index, hemoglobin A1c, total cholesterol/HDL ratio and blood pressure).
- Changes in utilization of health services, specifically, increases in outpatient visits to physicians and nurses, increases in the percentage of subjects having received an eye examination in the past year, increases in the number of times a health professional has examined subject's feet, and decreases in emergency room visits, hospitalizations, and hospital days.
- Improvements in beneficial self-management behaviors (aerobic exercise, communication with physicians, diet, self-monitoring of blood glucose and self-examination of the feet).
- Increases in perceived self-efficacy to manage diabetes.
Hypothesis 2. The changes in health related quality of life, metabolic status, health behaviors and health care utilization will be maintained for one year.
Hypothesis 3. Twelve to fifteen health care organizations in California will be interested in disseminating the program. This will be demonstrated by their willingness to send 2-3 persons each to a 5 day training which will allow their organization to replicate and perpetuate the program.
Hypothesis 4. 8-10 health care organizations in California will have offered at least two Diabetes Self-Management Programs to people with Type 2 diabetes one year following the above dissemination training. (It should be noted that this hypothesis can not be tested during the funded portion of the program. However, it our intent to contact all organizations participating in dissemination training one year following the training to determine what they have done with the program). The results of this follow-up will be reported to The Foundation.)
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with prior diagnosis of type 2 Diabetes.
- Able to speak and comprehend English.
- Able to give and complete consent forms.
- Able to complete baseline questionnaire and 2-3 follow-up questionnaires either in writing or by telephone.
- Able to attend respective community meetings or allow study staff to collect the following metabolic test measures: provide 3 drops of blood for Hemoglobin A1c and cholesterol HDL test (administered by subject), blood pressure measure, height and weight measures.
Key exclusion criteria (9 listed)
- Individuals not diagnosed with type 2 diabetes.
- Individuals diagnosed with type 1 diabetes.
- Pregnant women, including those diagnosed with gestational diabetes.
- Individuals who have been in active treatment for cancer in the past yar.
- Individuals not able to speak or comprehend 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 |
|---|---|---|
| Diabetes Self Management Program | Behavioural | – |
Primary outcome
hemoglobin A1
symptoms of hypoglycemia
symptoms of hyperglycemia
self-monitoring of blood glucose
self-efficacy to manage diabetes
7 secondary outcomes
fatigue
physical discomfort
activity limitations
health distress
self-rated health
aerobic exercise
communication with physicians
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 26 May 2008.
- Derived from this study: PubMed 19407333Lorig K, Ritter PL, Villa FJ, Armas J. Community-based peer-led diabetes self-management: a randomized trial. Diabetes Educ. 2009 Jul-Aug;35(4):641-51. doi: 10.1177/0145721709335006. Epub 2009 Apr 30.
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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.
Kate R Lorig principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self Management Program in people with Diabetes Mellitus, Type 2, run by Stanford University at 1 site in United States.
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 6 inclusion and 9 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 26 May 2008. 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 United States. 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?
hemoglobin A1. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00684086, which also lists 1 linked publication.
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 26 May 2008.