Cardiovascular DiseasesNCT00608387
Evaluating a Web-Based Cardiovascular Disease Risk Factor Reduction Program Among American Indians
A study testing Chronic disease management Web-based software in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Black Hills Center for American Indian Health at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have been few behaviorally based programs to lessen CVD risk among this population. The purpose of this study is to evaluate whether a Web-based program, in addition to usual medical care, can lower CVD risk factors among American… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Chronic disease management Web-based software
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed a baseline Education and Research Towards Health (EARTH) study examination
- Diagnosed with type 2 diabetes mellitus AND hypertension and/or hyperlipidemia
- Able to read and understand English
- Able to walk
Who cannot join
- Diagnosed with CVD at study entry
- Currently receiving active treatment for any non-skin cell cancer
- Any medical condition that study physicians believe would interfere with study participation or evaluation of results
- Mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with, the study procedures
- Kidney insufficiency, as indicated by serum creatinine level greater than 2.0 mg/dL for women and greater than 2.4 mg/dL for men
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Black Hills Center for American Indian Health
Rapid City, South Dakota, 57701
About this study
Official title: Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction
Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have been few behaviorally based programs to lessen CVD risk among this population. The purpose of this study is to evaluate whether a Web-based program, in addition to usual medical care, can lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of developing CVD.
Read the detailed description
Cardiovascular disease (CVD) is a leading cause of death among American Indians. Significant risk factors for CVD within the American Indian population include type 2 diabetes, tobacco use, poor dietary and physical activity habits, and poor medication and treatment adherence. Despite the fact that these risk factors can be reduced through behavior change, there have been few behaviorally based interventions aimed at American Indians to lessen their CVD risk. Research has shown that medical care is moving away from sporadic, standard doctors' office visits to a more continuous and interactive relationship with health care providers. A Web-based program that allows people to interact with remotely located doctors who can answer questions and provide advice may be beneficial at increasing treatment adherence and lowering CVD risk. This study will evaluate the use of a Web-based program at lowering CVD risk among American Indians with type 2 diabetes. Researchers will also analyze the cost-effectiveness of the Web-based program and the possible healthcare cost savings.
This 3-year study will enroll American Indian adults at high risk for CVD. Participants will be randomly assigned either to usual care at their local health facility or usual care plus the Web-based program. Participants using the Web-based program will have access to a Web site that will allow them to interact with two remotely based doctors. Participants will be able to send e-mail and instant messages to ask questions and receive information, advice, or motivational messages from the doctors. Participants will periodically enter their blood glucose test results and complete questionnaires online. Study visits, occurring twice a year for 3 years, will include blood pressure and body mass index (BMI) measurements, blood collection, and smoking status assessments.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension, Obesity, Tobacco Use Cessation
- Being tested
- Chronic disease management Web-based software
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension, Obesity, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic disease management Web-based softwareBehavioural
Also called CliniPro
Participants will have access to remotely based medical providers through the use of the Web-based software.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive usual care from their healthcare providers and have access to a Web-based CVD risk-factor management program. Receives: Behavioral: Chronic disease management Web-based software |
| B | No intervention | Participants will receive usual care from their healthcare providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbgA1c)
Measured: Measured at Year 3
Secondary outcomes (5)
Mean blood pressure
Measured: Measured at Year 3
Low-density lipoprotein cholesterol (LDL)
Measured: Measured at Year 3
BMI
Measured: Measured at Year 3
Smoking status
Measured: Measured at Year 3
Overall cost-effectiveness
Measured: Measured at Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Black Hills Center for American Indian Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Colorado, Denver, NuMedics, Inc., Cheyenne River Sioux Tribe Telephone Authority, Missouri Breaks Industries Research, Inc., Cheyenne River Sioux Tribe
- Responsible party
- Principal investigator, Jeffrey Henderson, MD, MPH, Black Hills Center for American Indian Health
- Investigators
- Jeffrey A. Henderson, MD, MPH, Principal investigator, Black Hills Center for American Indian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608387
- Sponsor's protocol ID
- 453
- Other IDs
- 1U01HL087422
- Status last verified
- Jun 2014
- First submitted
- 7 Jan 2008
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goldberg HI, Lessler DS, Mertens K, Eytan TA, Cheadle AD. Self-management support in a web-based medical record: a pilot randomized controlled trial. Jt Comm J Qual Saf. 2004 Nov;30(11):629-35, 589. doi: 10.1016/s1549-3741(04)30074-2.
PubMed 15565762Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159. doi: 10.1136/bmj.328.7449.1159.
PubMed 15142919Goldberg HI, Ralston JD, Hirsch IB, Hoath JI, Ahmed KI. Using an Internet comanagement module to improve the quality of chronic disease care. Jt Comm J Qual Saf. 2003 Sep;29(9):443-51. doi: 10.1016/s1549-3741(03)29053-5.
PubMed 14513667Henderson JA, Chubak J, O'Connell J, Ramos MC, Jensen J, Jobe JB; LOWPK Project Team. Design of a randomized controlled trial of a web-based intervention to reduce cardiovascular disease risk factors among remote reservation-dwelling American Indian adults with type 2 diabetes. J Prim Prev. 2012 Aug;33(4):209-22. doi: 10.1007/s10935-012-0276-x.
PubMed 23001642
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction
- ClinicalTrials.gov ID
- NCT00608387
- Acronym / sponsor ID
- 453
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension, Obesity, Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Black Hills Center for American Indian HealthUniversity, hospital or other
- Collaborators
- University of Washington, University of Colorado, Denver, NuMedics, Inc., Cheyenne River Sioux Tribe Telephone Authority, Missouri Breaks Industries Research, Inc., Cheyenne River Sioux Tribe
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Feb 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.
Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have been few behaviorally based programs to lessen CVD risk among this population. The purpose of this study is to evaluate whether a Web-based program, in addition to usual medical care, can lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of developing CVD.
Detailed description
Cardiovascular disease (CVD) is a leading cause of death among American Indians. Significant risk factors for CVD within the American Indian population include type 2 diabetes, tobacco use, poor dietary and physical activity habits, and poor medication and treatment adherence. Despite the fact that these risk factors can be reduced through behavior change, there have been few behaviorally based interventions aimed at American Indians to lessen their CVD risk. Research has shown that medical care is moving away from sporadic, standard doctors' office visits to a more continuous and interactive relationship with health care providers. A Web-based program that allows people to interact with remotely located doctors who can answer questions and provide advice may be beneficial at increasing treatment adherence and lowering CVD risk. This study will evaluate the use of a Web-based program at lowering CVD risk among American Indians with type 2 diabetes. Researchers will also analyze the cost-effectiveness of the Web-based program and the possible healthcare cost savings.
This 3-year study will enroll American Indian adults at high risk for CVD. Participants will be randomly assigned either to usual care at their local health facility or usual care plus the Web-based program. Participants using the Web-based program will have access to a Web site that will allow them to interact with two remotely based doctors. Participants will be able to send e-mail and instant messages to ask questions and receive information, advice, or motivational messages from the doctors. Participants will periodically enter their blood glucose test results and complete questionnaires online. Study visits, occurring twice a year for 3 years, will include blood pressure and body mass index (BMI) measurements, blood collection, and smoking status assessments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Chronic disease management Web-based softwareParticipants will receive usual care from their healthcare providers and have access to a Web-based CVD risk-factor management program. |
| B | No intervention | –Participants will receive usual care from their healthcare providers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completed a baseline Education and Research Towards Health (EARTH) study examination
- Diagnosed with type 2 diabetes mellitus AND hypertension and/or hyperlipidemia
- Able to read and understand English
- Able to walk
Key exclusion criteria (6 listed)
- Diagnosed with CVD at study entry
- Currently receiving active treatment for any non-skin cell cancer
- Any medical condition that study physicians believe would interfere with study participation or evaluation of results
- Mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with, the study procedures
- Kidney insufficiency, as indicated by serum creatinine level greater than 2.0 mg/dL for women and greater than 2.4 mg/dL for men
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 management Web-based softwareAlso: CliniProParticipants will have access to remotely based medical providers through the use of the Web-based software. | Behavioural | A |
Primary outcome
Glycosylated hemoglobin (HbgA1c)
Time frame: Measured at Year 3
5 secondary outcomes
Mean blood pressure
Time frame: Measured at Year 3
Low-density lipoprotein cholesterol (LDL)
Time frame: Measured at Year 3
BMI
Time frame: Measured at Year 3
Smoking status
Time frame: Measured at Year 3
Overall cost-effectiveness
Time frame: Measured at Year 3
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 4 Jun 2014.
- Background: PubMed 15565762Goldberg HI, Lessler DS, Mertens K, Eytan TA, Cheadle AD. Self-management support in a web-based medical record: a pilot randomized controlled trial. Jt Comm J Qual Saf. 2004 Nov;30(11):629-35, 589. doi: 10.1016/s1549-3741(04)30074-2.
- Background: PubMed 15142919Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159. doi: 10.1136/bmj.328.7449.1159.
- Background: PubMed 14513667Goldberg HI, Ralston JD, Hirsch IB, Hoath JI, Ahmed KI. Using an Internet comanagement module to improve the quality of chronic disease care. Jt Comm J Qual Saf. 2003 Sep;29(9):443-51. doi: 10.1016/s1549-3741(03)29053-5.
- Background: PubMed 23001642Henderson JA, Chubak J, O'Connell J, Ramos MC, Jensen J, Jobe JB; LOWPK Project Team. Design of a randomized controlled trial of a web-based intervention to reduce cardiovascular disease risk factors among remote reservation-dwelling American Indian adults with type 2 diabetes. J Prim Prev. 2012 Aug;33(4):209-22. doi: 10.1007/s10935-012-0276-x.
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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.
Jeffrey A. Henderson, MD, MPH principal investigator
Black Hills Center for American Indian Health
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 management Web-based software in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Black Hills Center for American Indian Health 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 4 inclusion and 6 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 4 Jun 2014. 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?
Glycosylated hemoglobin (HbgA1c) (time frame: Measured at Year 3). 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 NCT00608387, which also lists 4 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 4 Jun 2014.