Results Summary
What was the research about?
The risk of heart disease in rural Appalachian Kentucky is among the highest in the country. Risk factors for heart disease include having high blood pressure, eating unhealthy foods, being overweight, not exercising, smoking, and feeling depressed. Many people here have more than one risk factor. The chance of developing heart disease is higher in this part of the country, in part because many people don’t know much about these risks. They also have limited access to health care.
This study compared two ways to help people reduce their risk of heart disease. All people in the study got referrals to doctors they could see regularly. Half of the people also went to small-group classes taught by trained health workers from the community. The classes focused on healthy choices that people can make to reduce their risk for heart disease. The research team wanted to learn whether providing these classes was better at helping people reduce their risk for heart disease than only referring people to a doctor.
What were the results?
People who went to classes and got a referral to a doctor reduced their risk for heart disease more than people who got only a referral to a doctor. Those who went to classes had greater reductions in
- Blood pressure
- Cholesterol
- Weight
- Smoking
- Feelings of depression
- Overall risk of heart disease
Attending group classes didn’t change people’s reports on their quality of life.
In both groups, satisfaction with health care increased from the start to the end of the year-long study.
Who was in the study?
The study included 352 men and women who were at least 21 years old. The people in the study lived in rural Appalachian Kentucky. They didn’t see a doctor regularly before the study. They had more than one of the following risk factors for heart disease: high blood pressure, high cholesterol, type 2 diabetes, overweight or obesity, depression, and not enough exercise.
What did the research team do?
The team assigned people to one of two groups by chance. The team referred people in both groups to doctors to get advice for reducing their chances of developing heart disease. One group also attended six classes taught by trained health workers from their community. Health workers talked about eating a healthy diet, getting more exercise, reducing stress, quitting smoking, and managing other health problems.
At the start of the study and again 4 and 12 months later, people filled out surveys. The surveys asked about people’s quality of life, their overall risk for developing heart disease, and their satisfaction with their health care. The team also looked at peoples’ health records for blood pressure levels, cholesterol levels, weight, reports of depression, amount of exercise, and smoking status. The team compared the results from the two groups.
Community members, business owners, church leaders, and healthcare providers from Appalachian Kentucky helped plan the study. This group also helped find people to join the study.
What were the limits of the study?
The research team followed people in the study for only one year. People may have returned to unhealthy lifestyles after the study was over. The study included only people who were at risk for heart disease in rural Appalachian Kentucky. Results may vary in other areas.
Future research could follow people for more than one year. Studies could also look at offering classes taught by trained health workers in other rural and low-income communities.
How can people use the results?
Communities in rural areas may consider having trained health workers from the community provide health classes like those used in this study to help people reduce their risk of heart disease.
Professional Abstract
Objective
To compare the effect of a self-care cardiovascular disease (CVD) risk-reduction intervention with usual care for management of CVD risk factors among rural Appalachian community members
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 352 individuals living in rural Appalachian Kentucky who had ≥2 CVD risk factors |
| Interventions/ Comparators |
|
| Outcomes |
Primary: CVD risk factors, including blood pressure, lipid profile, body mass index, tobacco use, overall risk, depressive symptoms, and physical activity levels; quality of life Secondary: patient satisfaction |
| Timeframe | 12-month follow-up for primary outcomes |
In this randomized controlled trial, researchers examined whether HeartHealth, a self-care intervention, in combination with referral to a primary care provider, was more effective at reducing CVD risk factors than usual care involving only referral to a primary care provider. Researchers designed HeartHealth with input from the community, including members of the target population, business owners, local government officials, church leaders, and healthcare providers. HeartHealth provided intervention participants with information and support for lifestyle changes that reduce CVD risk. Intervention participants also attended six biweekly small-group classes. These classes, led by community health workers, focused on healthy eating, exercise, reducing stress, smoking cessation, and managing other health problems.
The study included 352 participants from rural eastern Appalachian Kentucky. Participants were at least 21 years old, had no primary care provider, and had more than one modifiable CVD risk factor, such as hypertension, hyperlipidemia, type 2 diabetes, body mass index ≥25, depressive symptoms, or a sedentary lifestyle.
Researchers randomized 184 participants to receive the HeartHealth intervention and 168 to receive only usual care. At baseline and again 4 and 12 months postintervention, researchers assessed CVD risk factors, quality of life, and patient satisfaction via patient surveys and medical record review. They also recorded gender, depression, and health literacy. Health literacy describes a person’s ability to obtain and understand basic health information for informed health decision making. For a year, researchers compared the effects of the HeartHealth intervention to the effects of usual care.
Results
After 12 months, the study found improvement in the following CVD risk factors in the HeartHealth group compared with the usual care group:
- Systolic blood pressure (p=0.002)
- Diastolic blood pressure (p=0.001)
- Total cholesterol (p=0.026)
- High-density lipoprotein (p=0.022)
- Body mass index (p=0.017)
- Smoking cessation (p<0.01)
- Framingham risk score (p=0.001)
- Depressive symptoms (p=0.01)
The two groups did not differ significantly after 12 months with respect to low-density lipoprotein or triglyceride levels or in the mental or physical health components of the quality-of-life measures.
The effectiveness of HeartHealth on overall risk did not differ with respect to gender, presence or absence of depression, and adequate or inadequate health literacy.
Patient satisfaction in both groups improved significantly from baseline to 12 months (p<0.001); there was no difference between the groups at 12 months.
Limitations
The study followed participants for only 12 months after enrollment. Findings do not indicate whether the observed risk-factor reductions can be maintained beyond 12 months or whether the reductions result in a delay or prevention of CVD. This study took place in rural Appalachian Kentucky; results may not be generalizable to other communities.
Conclusions and Relevance
This study demonstrated that a community-based intervention developed collaboratively with the community of interest and focused on self-care was better than usual care for reducing CVD risk factors in a rural Appalachian Kentucky population. HeartHealth was effective for individuals of both genders, with and without depressive symptoms and with and without adequate health literacy. With appropriate education and support, people with multiple CVD risk factors can reduce their risk of CVD.
Future Research Needs
Future studies involving a longer follow-up period could examine the long-term benefits of this type of intervention.
Final Research Report
View this project's final research report.
Stories and Videos
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
The awardee made the following revisions in response to peer review:
- The awardee added information about patient and stakeholder engagement and details about the intervention. The awardee also elaborated on usual-care conditions.
- The awardee noted the lack of information about the content of usual care as a study limitation. Further, the awardee revised the report’s conclusion to indicate that the intervention condition was superior to a referral to a primary care physician.
- The awardee provided the rationale for subgroup analyses based on gender, depressive symptoms, and health literacy. The investigator explained that the addition of these analyses came after completion of primary analyses. The awardee therefore described the analyses as exploratory.
- The awardee explained that recruitment focused on patients who lacked a regular primary care physician because such a lack is typical in the rural Appalachian region where the study took place. Also, the awardee explained that including participants who did have a regular physician would have introduced too much heterogeneity to test for treatment differences.