Telemonitoring and Case Management for Hypertensive and Remote-dwelling Patients With Chronic Kidney Disease - The Telemonitoring for Improved Kidney Outcomes Study (TIKO): A Clinical Research Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Effectiveness of telemonitoring and protocol-based case management versus usual care:
研究概览
简要总结
Background:
Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control.
Objective:
The primary aim of this study is to assess the mean difference in systolic BP (SBP) at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease (CKD) in Northern Alberta, Canada, comparing HBPT + usual care versus HBPT + a case manager. Other secondary objectives, including cost-effectiveness and acceptability of HBPT as well as occurrence of adverse events will also be assessed.
Methods
Design:
This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinical case management compared to HBPT with usual care.
Setting:
Peace River region in Northern Alberta Region, Canada.
Patients:
Primary care patients with CKD and hypertension.
Measurements:
Eligible patients will be randomized 1:1 to HBPT + BP case management versus HBPT + usual care. In the intervention arm, BP will be measured 4 times daily for 1 week, with medications titrated up or down by the study case manager until guideline targets (systolic BP [SBP]: <130mmHg) are achieved. Once BP is controlled, (i.e., to guideline-concordant targets), this 1-week protocol will be repeated every 3 months for 1 year. Patients in the control arm will also follow the same BP measurement protocol, however, there will be no interactions with the case manager; they will share their BP readings with their primary care physicians or nurse practitioners at scheduled visits.
Limitations:
Potential limitations of this study include the relatively short duration of follow-up, possible technological pitfalls, and need for patients to own a smartphone and have access to the internet to participate.
Conclusions:
As this study will focus on a high-risk population that has been characterized by a large care gap, it will generate important evidence that would allow targeted and effective population-level strategies to be implemented to improve health outcomes for high-risk hypertensive CKD patients in Canada's remote communities.
详细描述
Introduction:
Poorly controlled blood pressure (BP) is a risk factor for rapid progression of chronic kidney disease (CKD) to kidney failure and is also associated with cardiovascular (CV) morbidity and mortality.Poorly controlled BP is common and often associated with a higher rate of adverse clinical outcomes among remote/rural dwellers due to limited access to and lower quality of chronic disease care. Recent data have demonstrated that remote dwellers with CKD have less access to specialist care, receive poorer clinical care in all aspects of the care process, and exhibit worse clinical outcomes compared to their counterparts living in urban centres. Notably, among remote dwellers with CKD, a lack of BP control is the most important identified element of evidence-based care that is amenable to intervention.
Several studies have demonstrated the feasibility and accuracy of home BP telemonitoring (HBPT) and increased patient satisfaction compared to the usual care among those with some chronic conditions. In one study, when compared to usual care, the adjusted mean SBP differences with HBPT was -4•7 mm Hg [-7•0 to -2•4; P<0.0001] and when HBPT was combined with additional care (e.g. counselling, education, behavioural management, etc) the mean reduction in SBP and DBP was of a larger magnitude, suggesting that HBPT can be more efficacious when proactive additional support is provided. Findings from recent reviews and meta-analyses also show the positive impact of telemonitoring on patient outcomes for those with chronic conditions such as diabetes, asthma, and heart failure. One systematic review and meta-analysis on the effects of HBPT on blood pressure and kidney function in CKD patients reported significant reduction of SBP (-8.8 mmHg; [95% CI: -16.2, -1.4]; P=0.02) and DBP (-2.4 mmHg; [-3.8, -1.0]; P<0.001), and significant improvement in estimated glomerular filtration rate (5.35 mL/min/1.73m2; [2.49, 8.21]; P<0.001). Canadians living in remote communities continue to experience various challenges in accessing healthcare; lack of access to healthcare services and treatments in such settings is often compounded by geographical isolation from mainstream health services. Hence, the use of HBPT technologies could prove to be advantageous for improving control of hypertension and reducing associated target organ damage in populations in remote regions. However, the clinical efficacy, safety, acceptability, and cost-effectiveness of HBPT among CKD patients living in remote/rural communities with limited access to care is unknown.
Therefore, the primary aim of this study is to assess the mean difference in SBP at 12 months, from baseline in remote communities in Northern Alberta through a pragmatic RCT, comparing HBPT + usual care versus HBPT + a case manager.
Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to and more than 18 years with documented diagnosis of established CKD (not on dialysis with eGFR < 60 mL/min/1.73m2 and/or proteinuria > 1 g/day)
- •Remote dwelling patients in the Peace River region of Alberta, Canada
- •Patients known with hypertension (physician diagnosed / self reported and currently taking antihypertensive medications)
- •Owning a smartphone (iOS or Android) with access to wireless internet connection.
- •Proficiency in English language (both verbal and written); and ability and willingness to provide informed consent for participation.
- •Ability and willingness to use the HBPT device (≥ 80% recordings sent in the training period)
排除标准
- •Patients with hypertensive urgency or emergency identified during the training period (immediate consultation will be initiated with the patient's PCP or with a hypertension specialist)
- •Patients with stage 5 CKD (eGFR ≤ 15 ml/min/1.73m2) or patients receiving kidney replacement therapy
- •Heart failure with reduced ejection fraction
- •Presence of any terminal illness (life expectancy < 1 year)
- •Participation in any ongoing clinical drug trial
- •Pregnancy, lactation / breastfeeding
- •Planning to relocate out of the Peace River region or residence in an area without mobile phone coverage.
结局指标
主要结局
Effectiveness of telemonitoring and protocol-based case management versus usual care:
时间窗: Upto 12 months
The primary outcome will be the mean difference (MD) in home SBP at 12 months, from baseline values.
次要结局
- Proportion of patients with systolic blood pressure within guideline target, user acceptability, adverse events, cost-effectiveness and utility.(upto 12 months)