ObesityHeartHealthNCT01884246
Improving Heart Health in Appalachia
A study testing Self-care CVD risk reduction and Referral to primary care provider for CVD risk management in people with Obesity and Hypertension, run by Debra Moser at 1 site in United States.
Trial summary
Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue of having high rates of multiple CVD risk factors. There is a critical need to develop and test CVD risk reducing interventions that are appropriate and effective in Appalachia. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity, Hypertension, Hyperlipidemia
- What is being tested?
- Self-care CVD risk reduction and Referral to primary care provider for CVD risk management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 31 Dec 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- residents of eastern Appalachian Kentucky
- do not have a primary care provider
- at risk for CVD as reflected by having two or more of the following modifiable risk factors
- clinical diagnosis of hypertension or taking medications diagnosed for hypertension or found to be hypertensive on screening;
- clinical diagnosis of hyperlipidemia or taking medication for treating abnormal lipid levels, or any lipid abnormality found on screening that indicates hyperlipidemia;
- diagnosis of type 2 diabetes or HgA1c > 7% found on screening;
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- overweight or obese (body mass index ≥ 25 kg/m2);
- waist circumference > 40 inches in men or > 35 inches in women;
- clinical diagnosis of depression, on medications for depression or found to have depressive symptoms (score of > 9 on the Patient Health Questionnaire-9) by baseline screening;
- sedentary lifestyle meaning that the individual does not engage in at least 30 minutes of moderate activity for at least 4 days per week
Who cannot join
- known coronary artery disease, cerebrovascular disease, history of acute coronary syndrome or peripheral arterial disease;
- taking medications (e.g., protease inhibitors) that interfere with lipid metabolism;
- cognitive impairment that precludes an individual from understanding the consent process, answering questionnaires, or participating in the intervention;
- chronic drug abuse;
- end-stage renal or liver or pulmonary disease;
- current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer treatable by simple excision;
- gastrointestinal disease that requires special diets (e.g., Crohn's disease; celiac disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Health Disparities in Appalachians With Multiple Cardiovascular Disease Risk Factors
Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue of having high rates of multiple CVD risk factors. There is a critical need to develop and test CVD risk reducing interventions that are appropriate and effective in Appalachia. In the absence of such interventions, the dramatic CVD disparities seen in this area will continue to rise.
Lifestyle interventions reduce CVD risk by 44%. The investigators and others have demonstrated that lifestyle change is most effective when patients are given the tools to engage in effective self-care, and that interventions individualized to patients' specific needs and barriers are more effective than interventions that are not. The central hypothesis is that to be successful in Appalachia, CVD risk reducing interventions must focus on patient-centered lifestyle change that increase individuals' abilities to engage in self-care, must be culturally appropriate, and must have components that overcome barriers faced by individuals living in Appalachia.
Read more
The investigators propose a randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider and who are at risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success with (2) referral of patients to a primary care provider for management of their CVD risk factors. The investigators propose the following specific aims to be tested at 4 months and 1 year after baseline. To compare the short and long-term impact of the interventions on:
- the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile, hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction measures, and retention of recruited individuals. The investigators hypothesize that in comparison to the referral strategy, the multifaceted patient-centered, self-care intervention will engender more favorable outcomes across all measures.
- Conditions
- Obesity, Hypertension, Hyperlipidemia, Depression
- Being tested
- Self-care CVD risk reduction, Referral to primary care provider for CVD risk management
- Keywords
- lifestyle change, behavior change, obesity, hypertension, hyperlipidemia, physical inactivity, depression
- Medical subject headings
- Obesity, Hypertension, Hyperlipidemias, Depression, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-care CVD risk reductionBehavioural
Also called HeartHealth
A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients.
Referral to primary care provider for CVD risk managementOther
The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider.
| Study group | Role | What they receive |
|---|---|---|
| Self-care CVD risk reduction | Experimental | A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients. Receives: Behavioral: Self-care CVD risk reduction; Other: Referral to primary care provider for CVD risk management |
| Referral to primary care provider | Active comparator | The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider. Receives: Other: Referral to primary care provider for CVD risk management |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular risk factor selected by patient
Patient selects their own risk reduction goal from the following:
smoking, blood pressure, lipid profile, body mass index, hemoglobin-A1c for diabetics, depression, physical activity level, waist circumference
Measured: 4 months
cardiovascular risk factor selected by patient
Patient selects their own risk reduction goal from the following:
smoking, blood pressure, lipid profile, body mass index, hemoglobin-A1c for diabetics, depression, physical activity level, waist circumference
Measured: 12 months
Secondary outcomes (2)
all CVD risk factors of each patient
All CVD risk factors that each patient has are secondary outcomes
Measured: 4 months
all CVD risk factors of each patient
All CVD risk factors that each patient has are secondary outcomes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study start1 Aug 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debra Moser
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky Center for Excellence in Rural Health-Hazard
- Responsible party
- Sponsor-investigator, Debra Moser, University of Kentucky
- Investigators
- Debra K Moser, DNSc, RN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884246
- Sponsor's protocol ID
- PCORI 3048110484
- Acronym
- HeartHealth
- Status last verified
- Mar 2017
- First submitted
- 14 Jun 2013
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Disparities in Appalachians With Multiple Cardiovascular Disease Risk Factors
- ClinicalTrials.gov ID
- NCT01884246
- Acronym / sponsor ID
- HeartHealth / PCORI 3048110484
- Conditions
- Obesity, Hypertension, Hyperlipidemia, Depression
- Keywords
- lifestyle change, behavior change, obesity, hypertension, hyperlipidemia, physical inactivity, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Debra MoserUniversity, hospital or other
- Collaborators
- University of Kentucky Center for Excellence in Rural Health-Hazard
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 21 Jun 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.
Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue of having high rates of multiple CVD risk factors. There is a critical need to develop and test CVD risk reducing interventions that are appropriate and effective in Appalachia. In the absence of such interventions, the dramatic CVD disparities seen in this area will continue to rise.
Lifestyle interventions reduce CVD risk by 44%. The investigators and others have demonstrated that lifestyle change is most effective when patients are given the tools to engage in effective self-care, and that interventions individualized to patients' specific needs and barriers are more effective than interventions that are not. The central hypothesis is that to be successful in Appalachia, CVD risk reducing interventions must focus on patient-centered lifestyle change that increase individuals' abilities to engage in self-care, must be culturally appropriate, and must have components that overcome barriers faced by individuals living in Appalachia.
The investigators propose a randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider and who are at risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success with (2) referral of patients to a primary care provider for management of their CVD risk factors. The investigators propose the following specific aims to be tested at 4 months and 1 year after baseline. To compare the short and long-term impact of the interventions on:
- the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile, hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction measures, and retention of recruited individuals. The investigators hypothesize that in comparison to the referral strategy, the multifaceted patient-centered, self-care intervention will engender more favorable outcomes across all measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-care CVD risk reduction | Experimental | Behavioral: Self-care CVD risk reduction, Other: Referral to primary care provider for CVD risk managementA patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients. |
| Referral to primary care provider | Active comparator | Other: Referral to primary care provider for CVD risk managementThe study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- residents of eastern Appalachian Kentucky
- do not have a primary care provider
- at risk for CVD as reflected by having two or more of the following modifiable risk factors
Key exclusion criteria (7 listed)
- known coronary artery disease, cerebrovascular disease, history of acute coronary syndrome or peripheral arterial disease;
- taking medications (e.g., protease inhibitors) that interfere with lipid metabolism;
- cognitive impairment that precludes an individual from understanding the consent process, answering questionnaires, or participating in the intervention;
- chronic drug abuse;
- end-stage renal or liver or pulmonary disease;
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 |
|---|---|---|
| Self-care CVD risk reductionAlso: HeartHealthA patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients. | Behavioural | Self-care CVD risk reduction |
| Referral to primary care provider for CVD risk managementThe study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider. | Other | Referral to primary care provider, Self-care CVD risk reduction |
Primary outcome
cardiovascular risk factor selected by patient
Time frame: 4 months
Patient selects their own risk reduction goal from the following: smoking, blood pressure, lipid profile, body mass index, hemoglobin-A1c for diabetics, depression, physical activity level, waist circumference
cardiovascular risk factor selected by patient
Time frame: 12 months
Patient selects their own risk reduction goal from the following: smoking, blood pressure, lipid profile, body mass index, hemoglobin-A1c for diabetics, depression, physical activity level, waist circumference
2 secondary outcomes
all CVD risk factors of each patient
Time frame: 4 months
all CVD risk factors of each patient
Time frame: 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 10 Mar 2017.
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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.
Debra K Moser, DNSc, RN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-care CVD risk reduction and Referral to primary care provider for CVD risk management in people with Obesity and Hypertension, run by Debra Moser 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 10 inclusion and 7 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 10 Mar 2017. 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?
cardiovascular risk factor selected by patient (time frame: 4 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?
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 10 Mar 2017.