Addressing Hypertension Control in Africa (ADHINCRA) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Change in Blood Pressure levels from Baseline
研究概览
简要总结
A pilot cluster randomized control trial to test the feasibility of a multilevel, nurse-led, mobile health enhanced intervention in patients with uncontrolled hypertension in Ghana
详细描述
This is a two-arm pilot cluster randomized controlled trial (RCT) involving 240 participants with uncontrolled hypertension (HTN) with the healthcare setting as the unit of randomization and patients as the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. A statistician will generate the randomization using a computer-generated random sequence program with an allocation ratio of 1:1 and a block size of 6 (to assure equal numbers in each arm). After having met study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to the patients' healthcare setting's intervention assignment by the study coordinator. A cluster RCT has been chosen to avoid potential treatment contamination in which physicians within healthcare settings might unintentionally provide patients with different degrees of attention or blending of treatment protocols. The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.
The investigators will use quota sampling to over sample socioeconomically deprived persons to ensure that socioeconomically deprived persons comprise 50% of the sample. Poverty will be defined by (1) Household income, based on Ghana minimum monthly wage of 210 Ghana cedis (equivalent of $55). After screening eligible participants, the investigators will assign four clusters of 60 patients to the intervention or control arms. The investigators will require 30 patients in each cluster to be male and 30 to be female since in the investigators' previous work, men have been underrepresented potentially due to gender-differences in healthcare seeking behaviors. Men have also had inferior treatment and control rates in previous studies.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Other staff will conduct the evaluations using established protocols. They will remain blinded as to patients' group status throughout the study (i.e., pre-intervention, 1, 3, 6 & 9-month evaluations).
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included if they are 18-70 years old;
- •Male or female
- •Uncontrolled hypertension (SBP ≥140 mm Hg) based upon last outpatient encounter within the previous three months
- •Patients with previous strokes, coronary artery disease, up to stage three kidney disease and diabetes mellitus meeting BP cut-off criteria will be eligible for enrollment.
排除标准
- •Patients will be excluded if they fail to meet any of the above inclusion criteria
- •Severe cognitive impairment/dementia (Modified Mini-Mental State Examination (MMSE) score ≤24)
- •Severe global disability (modified Rankin Scale (mRS) score ≥3)
- •Not able to independently follow blood pressure measurement protocol or use of Smartphone for study protocol or without a care-giver to assist with BP monitoring at home
- •Patients with estimated glomerular filtration rate (eGFR) <30ml/min
研究组 & 干预措施
Usual Care
Patients in this arm of the study will receive usual care as determined by their providers. Usual care in the region typically involves at least one visit every 2-3 months for review of adherence to treatment, blood pressure control, and prescriptions for medication refills. Similar to the intervention group, participants will have a total of three follow-up visits which will be separate from their regular appointments during which study outcomes will be assessed.
干预措施: Usual Care Group (Other)
Enhanced Usual Care Group
All participants in the enhanced usual care arm must own a cell phone with at least short message service (SMS) and voicemail. To control for attention exposure, they will receive SMS messages daily dealing with healthy lifestyle behaviors (smoking, diet, physical activity) but not with medication adherence or hypertension-specific issues. Every three days (comparable to intervention group monitoring) they will receive an automated SMS directing them to a different 2-3 min video/YouTube™ clips on healthy lifestyles. Patients in this arm of the study will also receive usual care as determined by their providers. Usual care is described in the next section.
干预措施: Enhanced Usual Care Group (Behavioral)
结局指标
主要结局
Change in Blood Pressure levels from Baseline
时间窗: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Changes in Blood pressure levels, measured in mmHg, will be assessed at the baseline, 1-month, 3-month, 6-month, 9-month, and 12-month visits.
Change in Blood Pressure control by poverty status from Baseline
时间窗: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Blood pressure control - defined as systolic blood pressure (SBP) \< 140 mm Hg SBP reduction will be compared by deprivation status defined by monthly income \< 210 Ghana cedis determined at the enrollment visit.
次要结局
- Change in glycohemoglobin (A1C) between arms(Baseline, 1 month , 3 months, 6 months, 9 months, 12 months)
- Difference in Hypertensive Urgencies and Emergencies between arms(Baseline, 1 month , 3 months, 6 months, 9 months, 12 months)
- Difference in Cardiovascular Disease (CVD) Events between study arms(Baseline, 1 month , 3 months, 6 months, 9 months, 12 months)
- Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale(At 12 months)
- Change in the acceptability and usability of the Akoma pa app score as assessed by the Marshfield System Usability Survey(At 1 month , 3 months, 6 months, 9 months, 12 months)