Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial

NCT03302260 | Unknown

• 1 other identifier: REB17-1264
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pre-Eclampsia

Keywords

maternal health; pregnancy; pre-eclampsia

Outcome Measures

Primary Outcomes (6)

• Study feasibility - recruitment

  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).

  2 years

• Study feasibility - adherence

  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).

  2 years

• Study feasibility - study completion

  Acceptance of the study by women with HDP (i.e., feasibility) measured by overall study completion rate of ≥ 75% of participants.

  2 years

• Study feasibility - participant satisfaction

  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.

  2 years

• Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - audits

  Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by standardized audits.

  2 years

• Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - clinical outcomes

  Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by similar clinical outcomes between sites.

  2 years

Secondary Outcomes (20)

• Weight

  2 years

• Body mass index (BMI)

  2 years

• Waist-to-hip ratio

  2 years

• Smoking status

  2 years

• Postpartum depression

  2 years

Study Arms (2)

Control

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: CardioPrevent® Program

Interventions

CardioPrevent® Program BEHAVIORAL

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.

CardioPrevent® Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Kara Nerenberg

CONTACT

(403) 220-6376; kara.nerenberg@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 5, 2017
• Study Start: September 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share