ACTRN12622001583730尚未招募未知
Transforming blood pressure control in primary care through a novel remote decision support strategy based on a wearable blood pressure monitoring device plus a decision support strategy for GPs on medication prescription: The NEXTGEN-BP randomised trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Provided signed or electronic consent to participate in the trial
- •2. Males and females
- •3. Aged greater than or equal to 18 years
- •4. Average clinic attended seated mean BP greater than or equal to 140 and/or 90 mmHg, treated or untreated; or documented high BP in the last 3 months (clinic or home)
- •5. Willing to self-monitor BP
- •6. Own a compatible smartphone (iPhones running iOS 11 or newer and Android devices running 8.0 or newer) and ability to use it;
- •7. Access to an internet connection to allow GP telehealth consultations
- •8. The patient is deemed eligible for the treatment protocol by the GP.
排除标准
- •1. Taking 3 or more BP-lowering drugs.
- •2. Participant’s responsible primary care or other responsible physician deems not suitable for remote management – including use of wearable BP device, reporting of symptoms, and following electronic script-based titration steps.
- •3. Unable to complete trial procedures including cuffless BP monitoring.
- •4. Planned overseas travel in the first 30 days of joining the trial and if planning to travel for longer than 6 months during the trial period.
- •5. GP deems participant unsuitable to switch current antihypertensive therapy or a definite indication for combination therapy.
- •6. Pregnant or had a positive pregnancy test or unwilling to undertake a pregnancy test during the trial, or breastfeeding.
- •7. Of childbearing age and not using an acceptable method of contraception. Acceptable methods of birth control include hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g. condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization. Contraception should be used for at least 1 month before the screening visit and until the end of trial participation. Note: Females who are not at risk for pregnancy (i.e. in non-heterosexual relationships, single or who otherwise do not have male partners) are still eligible for the trial if they do not use contraception.
- •8. Evidence of secondary cause of hypertension e.g. renal artery stenosis
- •9. History of significant renal impairment (estimated glomerular filtration rate [eGFR] less than 50 ml/min/1.73 m squared), raised serum potassium (above lab normal limit).
- •10. Participation in a concurrent clinical trial of an investigational medicinal product. (Participants in observational, natural history and/or epidemiological studies not involving an intervention are eligible.)
- •11. Concomitant illness, physical impairment or mental condition which in the opinion of the trial team/primary care physician could interfere with the conduct of the trial including outcome assessments.
- •12. Inability or unwillingness to provide written informed consent.
研究者
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