Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot

NCT04752228 | Unknown

• 1 other identifier: 19-5967
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Adverse Childhood Experiences (ACEs) are potentially harmful events occurring during childhood that have been associated with chronic physical conditions in adulthood, including coronary artery disease (CAD). ACEs may constitute a portion of the remaining unexplained residual risk for CAD in adults. Identifying a means of addressing these experiences may mitigate their health consequences and result in improved cardiovascular outcomes. The primary objective of this study is to determine if patients who undergo ACE screening experience improved quality of life compared to patients who undergo conventional lifestyle assessment. This will be a single-centre, pragmatic, single-blinded (i.e. data analysts), 1:1, pilot randomized control trial.

Conditions

Adverse Childhood Experiences; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Patient-reported quality of life

  Degree of change in quality of life measured by the Short Form (36) Health Survey questionnaire

  3 and 6 months

Secondary Outcomes (5)

• Mortality

  6 months

• Cardiovascular hospitalization

  6 months

• Myocardial infarction

  6 months

• Stroke

  6 months

• Need for urgent repeat coronary revascularization

  6 months

Other Outcomes (7)

• Health behaviour

  3 and 6 months

• Depression

  3 and 6 months

• Anxiety

  3 and 6 months

Study Arms (2)

ACE Screen

EXPERIMENTAL

At the initial visit, the Philadelphia ACE Survey, a validated ACE questionnaire, will be administered by a research coordinator. A Lifestyle Assessment package will also be provided for self-completion, featuring General Demographics, Cardiovascular and Medication History, Health Behaviours, the Short Form (36) Health Survey, the Patient Health Questionnaire-9, the General Anxiety Disorder-7 questionnaire, the Seattle Angina Questionnaire-7, and the modified Perceived Need for Card Questionnaire. Patients who test positive for ACE will receive a 3-page printed ACE Resource Pack. At 3 months, the Lifestyle Assessment will be administered again. At 6 months, the Philadelphia ACE survey, Lifestyle Assessment, as well as a scale assessing their comfort level in being screened for ACE, disclosing their ACE status to their clinicians, and their confidence level in their clinicians' ability to help them manage their ACEs will be administered.

Other: Philadelphia ACE Survey; Other: Lifestyle Assessment

Lifestyle Assessment

OTHER

At the initial visit, no Philadelphia ACE Survey will be administered. The Lifestyle Assessment packaged will be provided for self-completion, featuring General Demographics, Cardiovascular and Medication History, Health Behaviours, the Short Form (36) Health Survey, the Patient Health Questionnaire-9, the General Anxiety Disorder-7 questionnaire, the Seattle Angina Questionnaire-7, and the modified Perceived Need for Card Questionnaire. At 3 months, the Lifestyle Assessment will be administered again. At 6 months, the Philadelphia ACE survey, Lifestyle Assessment, as well as a scale assessing their comfort level in being screened for ACE, disclosing their ACE status to their clinicians, and their confidence level in their clinicians' ability to help them manage their ACEs will be administered.

Other: Lifestyle Assessment

Interventions

Philadelphia ACE Survey OTHER

The Philadelphia ACE survey assesses the three major domains featured within the original ACE Study Questionnaire developed by Felitti et al. (abuse, neglect, and family dysfunction), in addition to five community-level stressors.

ACE Screen

Lifestyle Assessment OTHER

The Lifestyle Assessment questionnaire features the Short Form (36) Health Survey, Patient Health Questionnaire-9, General Anxiety Disorder-7 questionnaire, Seattle Angina Questionnaire-7, and modified Perceived Need for Card Questionnaire, which are validated questionnaires for the assessment of quality of life, depression, anxiety, angina, and perceived need for care, respectively.

ACE Screen; Lifestyle Assessment

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years at screening
• History of (1) acute coronary syndrome (ACS) OR (2) coronary artery disease (CAD) necessitating prior cardiovascular intervention. History of ACS determined by documentation of ST-elevation myocardial infarction or non-ST-segment elevation infarction 1-12 months prior to time of screening. History of CAD determined by documentation of percutaneous coronary intervention or coronary artery bypass surgery within the last 1-12 months.
• Able to complete a survey independently
• Access to a phone
• Willingness to participate as evidenced by signing of the study informed consent form

You may not qualify if:

• Inability to speak, read and write in English
• Cognitive impairment
• Severe physical or mental illness
• Limited life expectancy (projected to be less than 1 year)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Socar Research SA: collaborator

Study Sites (1)

Peter Munk Cardiac Centre - University Health Network

Toronto, Canada

RECRUITING

Related Publications (4)

• Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

  PMID: 9635069 BACKGROUND

• Godoy LC, Frankfurter C, Cooper M, Lay C, Maunder R, Farkouh ME. Association of Adverse Childhood Experiences With Cardiovascular Disease Later in Life: A Review. JAMA Cardiol. 2021 Feb 1;6(2):228-235. doi: 10.1001/jamacardio.2020.6050.

  PMID: 33263716 BACKGROUND

• Maunder RG, Hunter JJ, Tannenbaum DW, Le TL, Lay C. Physicians' knowledge and practices regarding screening adult patients for adverse childhood experiences: a survey. BMC Health Serv Res. 2020 Apr 15;20(1):314. doi: 10.1186/s12913-020-05124-6.

  PMID: 32293444 BACKGROUND

• Maunder RG, Tannenbaum DW, Permaul JA, Nutik M, Haber C, Mitri M, Costantini D, Hunter JJ. The prevalence and clinical correlates of adverse childhood experiences in a cross-sectional study of primary care patients with cardiometabolic disease or risk factors. BMC Cardiovasc Disord. 2019 Dec 19;19(1):304. doi: 10.1186/s12872-019-01277-3.

  PMID: 31881981 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Michael Farkouh, MD

  University Health Network-Toronto General Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Claudia Frankfurter, MD

  University Health Network-Toronto General Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Lucas C Godoy, MD

  University Health Network-Toronto General Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Christine Lay, MD

  Women's College Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Robert Maunder, MD

  Mount Sinai Hospital, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Farkouh, MD

CONTACT

416-340-3141; michael.farkouh@uhn.ca

Amanda Garrioch

CONTACT

416-340-4800; amanda.garrioch@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chair Research & Professor of Medicine, Department of Medicine, University of Toronto

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)