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	HeartHealth intervention and referral to primary care provider Usual care involving referral to primary care provider
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.