Phone-based Intervention Under Nurse Guidance After Stroke 2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
The overall objective of Phone-based Intervention under Nurse Guidance after Stroke II (PINGS-2) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to substantially improve longer term BP control among 500 recent stroke patients encountered at 10 hospitals in Ghana. Secondly, PINGS II seeks to develop an implementation strategy for routine integration and policy adoption of mhealth for post-stroke BP control in a LMIC setting. The investigators will leverage experience gained from the NIH Global Brain Disorders funded R21 pilot study (NS094033) to test efficacy of a refined, culturally-tailored, and potentially implementable intervention aimed at addressing the premier modifiable risk for stroke & other key variables in an under-resourced system burdened by suboptimal care & outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years (stroke is commoner above this age cut-off)
- •male or females (sex is a biologic variable of interest)
- •recent stroke (within one month of symptom onset)- stroke may be ischemic or hemorrhagic based on brain imaging or diagnosed clinically using the locally validated version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when neuroimaging is not feasible
- •uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and the eligibility screening visit) - SBP is used as the selection variable since most African hypertensives <60 years have systolic or combination systolic/ diastolic HTN and for most patients, controlling SBP also results in DBP control
- •patients or family carers should own a basic mobile phone that can receive text/audio messages.
排除标准
- •- Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).
研究组 & 干预措施
PINGS 2
Participants received a 12-month, multicomponent, nurse-led intervention in addition to usual post-stroke care. The intervention included:
Home blood pressure monitoring at least weekly with nurse follow-up for threshold breaches.
Mobile phone medication reminders (daily alarms set on the participant's own device).
Weekly audio health education messages in local dialects emphasizing stroke risk factor control and medication adherence.
Nurse navigators provided case management, coordinated clinic visits as needed, and tracked blood pressure readings and adherence.
干预措施: PINGS 2 (Behavioral)
Standard of Care
Participants received standard secondary prevention after stroke according to local guidelines. This typically included periodic physician follow-up, antihypertensive therapy, antiplatelets, and statins prescribed at the clinician's discretion.
To maintain contact frequency similar to the intervention group, participants received neutral lifestyle text messages unrelated to hypertension or stroke prevention.
干预措施: Standard of Care (Other)
结局指标
主要结局
Systolic Blood Pressure
时间窗: 12 months
Target goal of \<140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.
次要结局
- Number of Major Adverse Cardiovascular Events(12 months)
- Self-management(12 months)
- Number of Cardiovascular ED Encounters and Re-hospitalizations(12 months)
- Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire(12 months)
- Medication Adherence: Hill-Bone Compliance Scale(12 months)
- Medication Adherence: Medication Possession Ratio (MPR)(12 months)
研究者
Bruce Ovbiagele
Chief of Staff
Northern California Institute of Research and Education