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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, acceptability, and initial effect with grandparent caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified RICHH Intervention | Experimental | The investigators will employ a re-designed RICHH intervention and determine its feasibility and acceptability with custodial grandparents. |
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| Standard of Care | Active Comparator | The usual care control group will receive mini-iPads loaded with Caregiver and CVD risk reduction pamphlets in PDF format along with the associated links from the American Heart Association. Because the investigators may identify CVD risk factors in baseline testing in participants who do not know they have them, it would be unethical not to provide at least usual standard of care for these. Thus, all individuals enrolled in the study and in whom the investigators identify CVD risk factors will receive referral to a primary care provider for management of the CVD risk factors identified. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified RICHH | Behavioral | The RICHH intervention is an educational-behavioral and counseling intervention that promotes caregivers' knowledge, skills and motivation to engage in CVD risk reduction. The intervention is delivered individually to caregivers in their homes using video-conferencing technology on mini-iPads. The program consists of 12 weekly sessions [30-45 minutes] that will be held at the caregivers' preferred times. RICHH consists of 6 interactive modules (i.e., self-management for heart health, depressive symptom management, heart healthy eating, physical activity, co-morbid condition management, and adherence to medication and smoking cessation). The modified RICHH intervention utilizes focus group outcomes to employ modifications needed to target custodial grandparents from varied backgrounds (e.g., high ACEs, SDoH groups). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete the intervention and follow-up | Feasibility is measured by the count of participants who complete the intervention and follow-up components of the study | 4 months after baseline and 6 months after baseline |
| Percentage of participants who indicate acceptability of study intervention | Acceptability will be assessed in the domains of affective attitude, burden, opportunity costs, perceived effectiveness, and self-efficacy | 4 months after baseline |
| Physical activity | Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/day). Participants will wear the devices over 7-day periods at each data collection point. For each participant, the average proportion of time per day in moderate-to-vigorous physical activity (MVPA), out of total time wearing the monitors, will be calculated. | At baseline, 4 months after baseline, and 6 months after baseline |
| Food intake | Measured using the self-report Viocare Food Frequency Questionnaire. Data from Viocare will be used to generate Healthy Eating Index scores, which range from 0 to 100. Higher scores indicate better dietary quality. | At baseline, 4 months after baseline, and 6 months after baseline |
| Body mass index | BMI (kg/m2) will be calculated from height and body weight measured | At baseline, 4 months after baseline, and 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Measured by the average of three consecutive resting blood pressure measurements (both systolic and diastolic pressures). | At baseline, 4 months after baseline, and 6 months after baseline |
| Lipids |
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Grandparent (inclusion):
Grandparent (exclusion)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MinKyoung Song, PhD, RN | Contact | 503-418-2518 | songm@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| MinKyoung Song, PhD, RN | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care (SOC) | Behavioral | Referral to primary care provider |
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Measured using non-fasting total cholesterol obtained via finger stick
| At baseline, 4 months after baseline, and 6 months after baseline |
| Hemoglobin A1c (HbA1c) | Measured using non-fasting HbA1c obtained via finger stick | At baseline, 4 months after baseline, and 6 months after baseline |
| Nicotine exposure | Assessed via self-report of cigarette use/inhaled nicotine use, or secondhand smoke exposure. AHA Life's Essential 8 algorithm will generate a score (0-100), with lower scores indicating greater risk. | At baseline, 4 months after baseline, and 6 months after baseline |
| Depressive symptoms | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. | At baseline, 4 months after baseline, and 6 months after baseline |
| Waist circumference | Waist circumference will be measured using a nonextensible tape. At least two independent measurements will be taken and averaged. | At baseline, 4 months after baseline, and 6 months after baseline |