An Interactive Technology Enhanced Coaching Intervention for Black Women With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Systolic and Diastolic Blood Pressure (BP)
研究概览
简要总结
Hypertension (HTN) is a global problem affecting 972 million adults and an important public health burden since it is the main cause of cardiovascular disease and death, and the second leading cause of disability. Disproportionately affected, Black women have the highest prevalence of HTN in the United States. This research will evaluate potential interventions for possible community-based strategies for controlling HTN using interactive self-care strategies with coaching and technology. We hypothesize that participants who receive the Chronic Disease Self-Management Program (CDSMP) workshop and Interactive Technology Enhanced Coaching (ITEC) will have lower systolic/diastolic blood pressure (BP) and better adherence to antihypertensive medication(s) and lifestyle recommendations (physical activity, diet, and weight management) post intervention compared to participants receiving self-care management alone.
详细描述
This study includes a sample of community dwelling Black women with uncontrolled HTN. All participants meeting study eligibility requirements will receive the Chronic Disease Self-Management Program (CDSMP) workshop for 6 weeks. Participants from this pool will be randomized to the treatment and control arm. All study participants will continue to receive usual care for their HTN.
The intervention will be divided into three steps. At Step 1 for 3 months, the treatment arm will receive electronic monitoring (of participants' BP, weight, physical activity, food diary, and medication-taking) with weekly Interactive Technology Enhanced Coaching (ITEC) while the control arm will receive usual care with manual BP measurements monthly. At Step 2 for three months, the treatment arm will receive electronic monitoring with ITEC biweekly, and the control arm will receive electronic monitoring only. At Step 3 for three months, both the treatment arm and the control arm will receive electronic monitoring only.
Our sample of n=45 participants per arm (N=90 in total), will be measured (electronic measurements, anthropometric measurements, and data collection tools) at baseline, 3 months, 6 months, and at 9 months post CDSMP. A hierarchical, mixed-effects repeated measures design will be used to analyze the data.
The project is a two-arm randomized controlled trial with specific aims to determine whether the effects of CDSMP combined with ITEC will maintain BP control, attain medication adherence, and achieve lifestyle modifications (physical activity, diet, and weight management) compared to the CDSMP alone. We will test the hypothesis that:
- More participants in the CDSMP/ITEC arm will have controlled BP less than 130/80 at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in CDSMP alone.
- More participants in the CDSMP/ITEC arm will have higher levels of adherence to antihypertensive medication(s) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone.
- More participants in the CDSMP/ITEC arm, will have higher levels of adherence to lifestyle modifications (physical activity, diet, and weight management) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-identified as Black or African American;
- •18-70 years of age
- •English speaking
- •Has to live in the study community, Charlotte or surrounding area
- •Systolic BP greater than or equal to 130 and/or diastolic BP greater than or equal to 80 at screening
- •Prescribed to take one or more antihypertensive medication(s)
- •Smartphone or device
- •Bluetooth 4.0 and Provider network or Wi-Fi connectivity
排除标准
- •Self-report of mental illness that interferes with daily functioning
- •Unable to be physically active
- •Current pregnancy
- •Plans to move from the study area during the project
- •Systolic BP greater than or equal to 160 and/or diastolic BP greater than or equal to 100
- •Uncontrolled diabetes (HbA1c >8.5), hemodialysis, stroke (within past year with residual effects such as weakness, paralysis, speech difficulty, etc.), cancer treatment (for spread of cancer to other places in the body), or a heart attack (within the past year)
- •Concurrent participation in another research study and/or taken any Stanford self-management program
结局指标
主要结局
Change in Systolic and Diastolic Blood Pressure (BP)
时间窗: Baseline to 3 months, 6 months, and 9 months.
To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.
次要结局
- Medication Adherence by Proportion of Days Covered(Month 1 to Month 3, Month 6, and Month 9.)
- Change in Dietary Intake (Calories)(Month 1 to Month 3, Month 6, and Month 9.)
- Change in Dietary Intake (Sodium)(Month 1 to Month 3, Month 6, and Month 9.)
- Physical Activity (Change in Daily Steps)(Month 1 to Month 3, Month 6, and Month 9.)
- Change in Weight(Baseline to 3 months, 6 months, and 9 months.)
研究者
Willie Abel
Assistant Professor
University of North Carolina, Charlotte