Diabetes Mellitus, Type 2NCT01845857
A National Study of the Chronic Disease Self-Management Program
A study testing Chronic Disease Self-Management Workshop in people with Diabetes Mellitus, Type 2 and Chronic Disease, run by Stanford University at 1 site in United States.
Trial summary
This survey will address important research, practice, and policy questions: How does Chronic Disease Self-Management Program (CDSMP) impact participants' general health, their health behaviors, and their need for health care utilization? Who benefits most from the CDSMP program? Are predicted gains maintained over a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Chronic Disease
- What is being tested?
- Chronic Disease Self-Management Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,170 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2013
- 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
- Age 18 or over
- Has a chronic health condition
- Attending a Chronic Disease Self-Management Workshop at a designated host site in the United states
- Speaks English or Spanish
- For blood test portion of study: have type 2 diabetes
Who cannot join
- Do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This survey will address important research, practice, and policy questions: How does Chronic Disease Self-Management Program (CDSMP) impact participants' general health, their health behaviors, and their need for health care utilization? Who benefits most from the CDSMP program? Are predicted gains maintained over a six and twelve month period? Can critical clinical changes be seen for those who are diabetic?
Read the detailed description
A national survey of participant outcomes is important for documenting how the CDSMP program is impacting people with chronic diseases and influencing health care outcomes. This study will help bridge the research to practice gap and further our knowledge about the outcomes of evidence?based programs that are widely disseminated.
Investigators hope to learn the answers to the following questions for English and Spanish-speaking populations:
- How does the CDSMP impact a person's general health?
- Does the CDSMP increase the use of healthful behaviors?
- Does the CDSMP impact health care utilization?
- What are the characteristics of those who benefit from the CDSMP?
- Can these benefits be maintained over 6 and 12 month periods?
- For people with type 2 diabetes, and hemoglobin A1c be impacted by the CDSMP?
- Conditions
- Diabetes Mellitus, Type 2, Chronic Disease
- Being tested
- Chronic Disease Self-Management Workshop
- Keywords
- Long term health problems, chronic disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Self-Management WorkshopBehavioural
6 week, small group self-management workshop
| Study group | Role | What they receive |
|---|---|---|
| Chronic Disease Self-Management Workshop | Experimental | Longitudinal study of participants who take the CDSMP workshop Receives: Behavioral: Chronic Disease Self-Management Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Status (symptoms, activities limitations)
Measured: Baseline to 6 months
Change in Health Status (symptoms, activities limitations)
Measured: baseline to 12 months
Secondary outcomes (8)
Change in Health behaviors (exercise, medical adherence)
Measured: baseline to 6 months
Change in health related quality of life
Measured: baseline to 6 months
Change in Metabolic control (HbA1c for type 2 diabetics)
Measured: baseline to 6 months
Change in Health Care Utilization
MD, emergency, hospital times and total nights
Measured: baseline to 6 months
Change in Health behaviors (exercise, medical adherence)
Measured: baseline to 12 months
Change in health related quality of life
Measured: baseline to 12 months
Change in Metabolic control (HbA1c for type 2 diabetics)
Measured: baseline to 12 months
Change in Health Care Utilization
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Lorig, Stanford University
- Investigators
- Kate R Lorig, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845857
- Sponsor's protocol ID
- SU-07212010-6585
- Other IDs
- 18933 IRB Protocol
- Status last verified
- Aug 2010
- First submitted
- 9 Aug 2010
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
PubMed 11606875Lorig KR, Ritter PL, Gonzalez VM. Hispanic chronic disease self-management: a randomized community-based outcome trial. Nurs Res. 2003 Nov-Dec;52(6):361-9. doi: 10.1097/00006199-200311000-00003.
PubMed 14639082
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Study of the Chronic Disease Self-Management Program
- ClinicalTrials.gov ID
- NCT01845857
- Acronym / sponsor ID
- SU-07212010-6585
- Conditions
- Diabetes Mellitus, Type 2, Chronic Disease
- Keywords
- Long term health problems, chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,170 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 May 2013 (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.
This survey will address important research, practice, and policy questions: How does Chronic Disease Self-Management Program (CDSMP) impact participants' general health, their health behaviors, and their need for health care utilization? Who benefits most from the CDSMP program? Are predicted gains maintained over a six and twelve month period? Can critical clinical changes be seen for those who are diabetic?
Detailed description
A national survey of participant outcomes is important for documenting how the CDSMP program is impacting people with chronic diseases and influencing health care outcomes. This study will help bridge the research to practice gap and further our knowledge about the outcomes of evidence?based programs that are widely disseminated.
Investigators hope to learn the answers to the following questions for English and Spanish-speaking populations:
- How does the CDSMP impact a person's general health?
- Does the CDSMP increase the use of healthful behaviors?
- Does the CDSMP impact health care utilization?
- What are the characteristics of those who benefit from the CDSMP?
- Can these benefits be maintained over 6 and 12 month periods?
- For people with type 2 diabetes, and hemoglobin A1c be impacted by the CDSMP?
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Disease Self-Management Workshop | Experimental | Behavioral: Chronic Disease Self-Management WorkshopLongitudinal study of participants who take the CDSMP workshop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or over
- Has a chronic health condition
- Attending a Chronic Disease Self-Management Workshop at a designated host site in the United states
- Speaks English or Spanish
- For blood test portion of study: have type 2 diabetes
Key exclusion criteria (1 listed)
- Do not meet inclusion criteria
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 |
|---|---|---|
| Chronic Disease Self-Management Workshop6 week, small group self-management workshop | Behavioural | Chronic Disease Self-Management Workshop |
Primary outcome
Change in Health Status (symptoms, activities limitations)
Time frame: Baseline to 6 months
Change in Health Status (symptoms, activities limitations)
Time frame: baseline to 12 months
8 secondary outcomes
Change in Health behaviors (exercise, medical adherence)
Time frame: baseline to 6 months
Change in health related quality of life
Time frame: baseline to 6 months
Change in Metabolic control (HbA1c for type 2 diabetics)
Time frame: baseline to 6 months
Change in Health Care Utilization
Time frame: baseline to 6 months
Change in Health behaviors (exercise, medical adherence)
Time frame: baseline to 12 months
Change in health related quality of life
Time frame: baseline to 12 months
Change in Metabolic control (HbA1c for type 2 diabetics)
Time frame: baseline to 12 months
Change in Health Care Utilization
Time frame: baseline to 12 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 3 May 2013.
- Background: PubMed 11606875Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
- Background: PubMed 14639082Lorig KR, Ritter PL, Gonzalez VM. Hispanic chronic disease self-management: a randomized community-based outcome trial. Nurs Res. 2003 Nov-Dec;52(6):361-9. doi: 10.1097/00006199-200311000-00003.
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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 Chronic Disease Self-Management Workshop in people with Diabetes Mellitus, Type 2 and Chronic Disease, 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 5 inclusion and 1 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 3 May 2013. 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?
Change in Health Status (symptoms, activities limitations) (time frame: Baseline to 6 months). The study lists 2 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 NCT01845857, which also lists 2 linked publications.
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 3 May 2013.