IMPROVE (Identifying Methods for Postpartum Reduction of Vascular Events): Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 主要终点
- Study feasibility - adherence
研究概览
简要总结
IMPROVE is a pilot RCT with a behavioral intervention component (CardioPrevent program). The primary objectives of this pilot study are to assess the feasibility of the implementation of a postpartum CVD prevention lifestyle program in women with a HDP as well as the transferability and fidelity of the Ottawa-based CardioPrevent® program to a centre in Calgary (following a "Train the Trainer" model). Secondary objectives include an initial evaluation of the effectiveness of this intervention on clinical outcomes and measures of microvascular function between study arms at one year.
详细描述
- Background and Rationale
Cardiovascular disease (CVD) (i.e., coronary artery disease, stroke, and peripheral arterial disease) is one of the leading causes of morbidity and mortality in Canada, particularly amongst women. Women with hypertensive disorders of pregnancy (HDP) represent one of the highest-risk populations for premature CVD and CVD mortality. The 2011 American Heart Association (AHA) Guidelines on the prevention of CVD in women now include HDP as an independent CVD risk factor in the evaluation of CVD risk. To achieve "ideal cardiovascular health" targets, healthy lifestyle modifications are suggested as first-line therapy, with pharmacotherapy as second line. The immediate postpartum period may be an early window of opportunity for early upstream CVD prevention, capitalizing on a woman's increased motivation to improve her health. Despite these recommendations and opportunity for early CVD prevention, there is little published data, and, in particular, there are no randomized controlled trials (RCT) assessing the short-term or long-term effectiveness of lifestyle interventions in women with HDP.
To address this important clinical problem and knowledge gap, the interdisciplinary IMPROVE team adapted the evidence-based University of Ottawa Heart Institute CardioPrevent® Lifestyle program to proactively address the unique barriers to, and facilitators of behaviour change in early postpartum women with HDP. Prior to undertaking a widespread evaluation of CardioPrevent® in a CVD prevention study for women with HDP, a pre-assessment of the feasibility of this postpartum lifestyle program using this research approach through a pilot study is essential. In addition, this pilot study will provide important information on CardioPrevent®'s effectiveness on modifying clinically-important cardiovascular-related clinical outcomes and novel, non-invasive measures of microvascular function in early postpartum women with HDP to inform the design of a larger CVD prevention study. This pilot RCT will be the first to assess the feasibility and effects of a one-year postpartum-specific CVD prevention lifestyle program in women with a HDP. 2. Research Questions & Objectives
The primary objectives of this pilot study are to assess the feasibility of the implementation of a postpartum CVD prevention lifestyle program in women with a HDP as well as the transferability and fidelity of the Ottawa-based CardioPrevent® program to a centre in Calgary (following a "Train the Trainer" model). Secondary objectives include: an initial evaluation of the effectiveness of this intervention on clinical outcomes and measures of microvascular function between study arms at one year. 3. Methods
Study Design: A 2-year, single centre, single-blind, pilot randomized controlled trial (RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The nature of the intervention (i.e., the CardioPrevent® cognitive-behavioural lifestyle counsellor) does not lend itself to blinding of the participant. However, the research assistant responsible for the outcome assessments will be blinded to each participant's group allocation and will be instructed not to ask any questions pertaining to the study intervention. The study statistician will also be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult women aged 18 years or older;
- •diagnosis of a HDP (i.e., preeclampsia, eclampsia or gestational hypertension);
- •delivering at The Foothills Medical Centre (FMC) in Calgary, Alberta;
- •ability to read, write, understand, and provide informed consent in English; and
- •have telephone access.
排除标准
- •pre-existing vascular disease (coronary artery disease [i.e., stable angina, unstable angina,
- •myocardial infarction, percutaneous coronary intervention or coronary artery bypass surgery],
- •cerebrovascular disease [i.e., ischemic stroke or transient ischemic attack], or peripheral arterial
- •disease [i.e., known abnormal ankle-brachial indices, symptoms of intermittent claudication, or
- •bypass surgery to the extremities]);
- •chronic hypertension;
- •diabetes (type 1 or type 2);
- •pre-pregnancy kidney disease;
- •planning another pregnancy within one year;
- •counselling may not be appropriate (i.e., impaired cognition);
- •live more than 200 km outside the Calgary region; and
- •planning to move outside the Calgary region within one year of randomization.
研究组 & 干预措施
Control
Participants in the control arm will receive standard postpartum clinical care through the participants' usual healthcare providers. No intervention will be administered. Participants in both arms will receive educational material about the risk of CVD, and CVD prevention for women with HDP from the Preeclampsia Foundation.
CardioPrevent® Program
In addition to standard care, participants randomized to the intervention arm will also receive the CardioPrevent® Program. This is a 1-year, evidence-based behaviour change lifestyle program that consists of 25 contacts (in person, by phone and in groups) with a trained lifestyle counsellor to facilitate desired lifestyle behaviours within the participants' own social context. Participants in both arms will receive educational material about the risk of CVD, and CVD prevention for women with HDP from the Preeclampsia Foundation.
干预措施: CardioPrevent® Program (Behavioral)
结局指标
主要结局
Study feasibility - adherence
时间窗: 2 years
Acceptance of the study by women with HDP (i.e., feasibility) measured by participant adherence of ≥ 80% to the lifestyle program (i.e., 20/25 contacts with counsellor completed).
Study feasibility - recruitment
时间窗: 2 years
Acceptance of the study by women with HDP (i.e., feasibility) measured by recruitment rate of ≥ 20% over a 6-month time period (as per weekly recruitment logs).
Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - audits
时间窗: 2 years
Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by standardized audits.
Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - clinical outcomes
时间窗: 2 years
Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by similar clinical outcomes between sites.
Study feasibility - study completion
时间窗: 2 years
Acceptance of the study by women with HDP (i.e., feasibility) measured by overall study completion rate of ≥ 75% of participants.
Study feasibility - participant satisfaction
时间窗: 2 years
Acceptance of the study by women with HDP (i.e., feasibility) measured by participant satisfaction score of ≥ fair on the Client Satisfaction Questionnaire at the end of study.
次要结局
- Body mass index (BMI)(2 years)
- Microvascular function - brachial artery hyperemic velocity(2 years)
- Changes in amount of physical activity recorded in questionnaire(2 years)
- Changes in nutrient status(2 years)
- Weight(2 years)
- Urine albumin to creatinine ratio(2 years)
- CVD risk(2 years)
- Waist-to-hip ratio(2 years)
- Smoking status(2 years)
- Blood pressure(2 years)
- Fasting lipids(2 years)
- HbA1C(2 years)
- Changes in amount of physical activity recorded in activity logs(2 years)
- Changes in amount of physical activity captured by accelerometer(2 years)
- Postpartum depression(2 years)
- Fasting glucose(2 years)
- Metabolic syndrome(2 years)
- Microvascular function - flow mediated dilation (FMD)(2 years)
- Microvascular function - peripheral arterial tonometry (PAT)(2 years)
- Changes in dietary behavior(2 years)