Coronary Heart DiseasePhase 1NCT00164658
Evaluating Tools for Health Promotion and Disease Prevention
A Phase 1 study testing Familial risk assessment and personalized prevention messages in people with Coronary Heart Disease and Stroke, run by Centers for Disease Control and Prevention at 3 sites in United States.
Trial summary
The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Stroke, Diabetes
- What is being tested?
- Familial risk assessment and personalized prevention messages
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8,400 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2005to Oct 2007
- Phase
- Phase 1
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- member of participating primary care practice network
- able to provide informed consent
- able to complete data assessment tools in English
Who cannot join
- diagnosis of CHD, stroke, diabetes, breast cancer, ovarian cancer, or colorectal cancer
- currently pregnant
- evidence of cognitive impairment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Great Lakes Research into Practice Network (GRIN)
Ann Arbor, Michigan, 48109
Evanston Northwestern Healthcare (ENH) internal medicine, family practice, and OB/GYN practices
Evanston, Illinois, 60201
American Academy of Family Physicians National Research Network (AAFP-NRN).
Leawood, Kansas, 66211
About this study
The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S.
Read the detailed description
The purpose of this study is to evaluate the clinical utility of a new family history tool, Family Healthware™ by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services. The hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized (not personalized) prevention messages. An additional hypothesis, tested when participants see their primary care physician during the study, is that providing a copy of the graphical family history, risk and prevention messages to the patient's physician will increase delivery of recommended preventive services (screening, referral, and health habit advice).
The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers. The practices will be randomized into two groups. Patients in practices randomized to Group 1 will complete a pre-test and the family history tool, and will receive personalized prevention messages based on their level of familial risk and current risk behaviors. After six months, Group 1 patients will complete a post-test. Patients in Group 2 will complete the pre-test and receive standard prevention messages (appropriate for sex) about maintaining good health and preventing disease. After 6 months Group 2 patients will complete the post-test and the family history tool. The pre- and post-test will include assessment of risk factors, use of medical services (especially preventive services), interest in modifying health behaviors, risk perceptions, etc. The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata (average, moderate, high).
- Conditions
- Coronary Heart Disease, Stroke, Diabetes, Breast Cancer, Ovarian Cancer, Colorectal Cancer
- Being tested
- Familial risk assessment and personalized prevention messages
- Keywords
- family history, familial risk, behavior change
- Medical subject headings
- Coronary Disease, Stroke, Diabetes Mellitus, Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familial risk assessment and personalized prevention messagesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation
Secondary outcomes (1)
Primary care physicians' provision of preventive services in response to family medical history.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 8,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Case Western Reserve University, American Academy of Family Physicians National Research Network, Evanston Northwestern Healthcare Research Institute, University of Michigan
- Investigators
- Louise S Acheson, MD, MS, Principal investigator, Case Western Reserve University Department of Family Medicine & CWRU/UHC Comprehensive Cancer CenterWendy S Rubinstein, MD, PhD, Principal investigator, Evanston Northwestern Healthcare Research InstituteSuzanne M O'Neill, MA, MS, PhD, Principal investigator, Evanston Northwestern Healthcare Research InstituteMack T Ruffin IV, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164658
- Sponsor's protocol ID
- CDC-OGDP-4444
- Other IDs
- U36/CCU319276-MM-0630, U50/CCU300860-TS-1216, U36/CCU319276-MM-0789
- Status last verified
- Jan 2010
- First submitted
- 12 Sep 2005
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang C, Sen A, Plegue M, Ruffin MT 4th, O'Neill SM, Rubinstein WS, Acheson LS; Family Healthware Impact Trial (FHITr) Group; Family Healthware Impact Trial FHITr Group. Impact of family history assessment on communication with family members and health care providers: A report from the Family Healthware Impact Trial (FHITr). Prev Med. 2015 Aug;77:28-34. doi: 10.1016/j.ypmed.2015.04.007. Epub 2015 Apr 19.
PubMed 25901453Wang C, Sen A, Ruffin MT 4th, Nease DE Jr, Gramling R, Acheson LS, O'Neill SM, Rubinstein WS; Family Healthware Impact Trial (FHITr) Group. Family history assessment: impact on disease risk perceptions. Am J Prev Med. 2012 Oct;43(4):392-8. doi: 10.1016/j.amepre.2012.06.013.
PubMed 22992357Dorman JS, Valdez R, Liu T, Wang C, Rubinstein WS, O'Neill SM, Acheson LS, Ruffin MT 4th, Khoury MJ. Health beliefs among individuals at increased familial risk for type 2 diabetes: implications for prevention. Diabetes Res Clin Pract. 2012 May;96(2):156-62. doi: 10.1016/j.diabres.2011.12.017. Epub 2012 Jan 17.
PubMed 22257420Ruffin MT 4th, Nease DE Jr. Using patient monetary incentives and electronically derived patient lists to recruit patients to a clinical trial. J Am Board Fam Med. 2011 Sep-Oct;24(5):569-75. doi: 10.3122/jabfm.2011.05.100169.
PubMed 21900440O'Neill SM, Rubinstein WS, Wang C, Yoon PW, Acheson LS, Rothrock N, Starzyk EJ, Beaumont JL, Galliher JM, Ruffin MT 4th; Family Healthware Impact Trial group. Familial risk for common diseases in primary care: the Family Healthware Impact Trial. Am J Prev Med. 2009 Jun;36(6):506-14. doi: 10.1016/j.amepre.2009.03.002.
PubMed 19460658
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Tools for Health Promotion and Disease Prevention
- ClinicalTrials.gov ID
- NCT00164658
- Acronym / sponsor ID
- CDC-OGDP-4444
- Conditions
- Coronary Heart Disease, Stroke, Diabetes, Breast Cancer, Ovarian Cancer, Colorectal Cancer
- Keywords
- family history, familial risk, behavior change
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,400 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Case Western Reserve University, American Academy of Family Physicians National Research Network, Evanston Northwestern Healthcare Research Institute, University of Michigan
- Study start
- Sep 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 14 Sep 2005 (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 study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S.
Detailed description
The purpose of this study is to evaluate the clinical utility of a new family history tool, Family Healthware™ by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services. The hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized (not personalized) prevention messages. An additional hypothesis, tested when participants see their primary care physician during the study, is that providing a copy of the graphical family history, risk and prevention messages to the patient's physician will increase delivery of recommended preventive services (screening, referral, and health habit advice).
The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers. The practices will be randomized into two groups. Patients in practices randomized to Group 1 will complete a pre-test and the family history tool, and will receive personalized prevention messages based on their level of familial risk and current risk behaviors. After six months, Group 1 patients will complete a post-test. Patients in Group 2 will complete the pre-test and receive standard prevention messages (appropriate for sex) about maintaining good health and preventing disease. After 6 months Group 2 patients will complete the post-test and the family history tool. The pre- and post-test will include assessment of risk factors, use of medical services (especially preventive services), interest in modifying health behaviors, risk perceptions, etc. The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata (average, moderate, high).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- member of participating primary care practice network
- able to provide informed consent
- able to complete data assessment tools in English
Key exclusion criteria (3 listed)
- diagnosis of CHD, stroke, diabetes, breast cancer, ovarian cancer, or colorectal cancer
- currently pregnant
- evidence of cognitive impairment
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 |
|---|---|---|
| Familial risk assessment and personalized prevention messages | Behavioural | – |
Primary outcome
Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation
1 secondary outcome
Primary care physicians' provision of preventive services in response to family medical history.
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 7 Jan 2010.
- Derived from this study: PubMed 25901453Wang C, Sen A, Plegue M, Ruffin MT 4th, O'Neill SM, Rubinstein WS, Acheson LS; Family Healthware Impact Trial (FHITr) Group; Family Healthware Impact Trial FHITr Group. Impact of family history assessment on communication with family members and health care providers: A report from the Family Healthware Impact Trial (FHITr). Prev Med. 2015 Aug;77:28-34. doi: 10.1016/j.ypmed.2015.04.007. Epub 2015 Apr 19.
- Derived from this study: PubMed 22992357Wang C, Sen A, Ruffin MT 4th, Nease DE Jr, Gramling R, Acheson LS, O'Neill SM, Rubinstein WS; Family Healthware Impact Trial (FHITr) Group. Family history assessment: impact on disease risk perceptions. Am J Prev Med. 2012 Oct;43(4):392-8. doi: 10.1016/j.amepre.2012.06.013.
- Derived from this study: PubMed 22257420Dorman JS, Valdez R, Liu T, Wang C, Rubinstein WS, O'Neill SM, Acheson LS, Ruffin MT 4th, Khoury MJ. Health beliefs among individuals at increased familial risk for type 2 diabetes: implications for prevention. Diabetes Res Clin Pract. 2012 May;96(2):156-62. doi: 10.1016/j.diabres.2011.12.017. Epub 2012 Jan 17.
- Derived from this study: PubMed 21900440Ruffin MT 4th, Nease DE Jr. Using patient monetary incentives and electronically derived patient lists to recruit patients to a clinical trial. J Am Board Fam Med. 2011 Sep-Oct;24(5):569-75. doi: 10.3122/jabfm.2011.05.100169.
- Derived from this study: PubMed 19460658O'Neill SM, Rubinstein WS, Wang C, Yoon PW, Acheson LS, Rothrock N, Starzyk EJ, Beaumont JL, Galliher JM, Ruffin MT 4th; Family Healthware Impact Trial group. Familial risk for common diseases in primary care: the Family Healthware Impact Trial. Am J Prev Med. 2009 Jun;36(6):506-14. doi: 10.1016/j.amepre.2009.03.002.
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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.
Louise S Acheson, MD, MS principal investigator
Case Western Reserve University Department of Family Medicine & CWRU/UHC Comprehensive Cancer Center
Wendy S Rubinstein, MD, PhD principal investigator
Evanston Northwestern Healthcare Research Institute
Suzanne M O'Neill, MA, MS, PhD principal investigator
Evanston Northwestern Healthcare Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Familial risk assessment and personalized prevention messages in people with Coronary Heart Disease and Stroke, run by Centers for Disease Control and Prevention at 3 sites 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 3 inclusion and 3 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 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation. 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 NCT00164658, which also lists 5 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 7 Jan 2010.