Recruiting

My Heart Care

Sponsor:

University of Calgary

Code:

NCT06920927

Conditions

Chronic Kidney Disease

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decision aid

Study Details

Brief summary:

Many people with kidney disease also have heart disease. The procedures used to diagnose and treat heart disease (e.g., angiograms, angioplasty, or surgery) can improve symptoms and cardiovascular outcomes, but pose greater risks of kidney complications for people with chronic kidney disease. It's therefore important that patients with kidney disease and their health care providers understand the benefits versus risks of these procedures and use that information to make informed decisions regarding their health care.

Prior research done with patients with kidney disease and their health care providers has led to the develop of a decision aid designed to help doctors provide personalized information on the benefits versus risks of having a heart procedure, as well as help patients communicate their own values and preferences to their doctor. This information is crucial for shared decision making, as previous research has shown that preferences and values vary for individual patients with kidney diseases, and should be incorporated into the decision-making process for heart disease management. The decision aid, called "My Heart Care and CKD", supports shared decision-making between patients with kidney disease and heart their care providers. This trial will implement and evaluate this decision aid within cardiovascular care in a pilot trial in Canada.

Conditions

Chronic Kidney Disease

Coronary Artery Disease

Study ID

NCT06920927

Start date

Dec 1, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (18 years of age or older)
  • Chronic kidney disease
  • Coronary artery disease (non-ST elevation acute coronary syndrome (ACS) or symptoms or signs of stable coronary heart disease)
  • Able to communicate in English or French or through a support person who speaks English or French
  • Patient has the cognitive ability or has a surrogate decision maker capable of participating in shared decision making based on the discretion of the attending physician

Exclusion Criteria:

  • End stage kidney failure already being treated with dialysis or with an eGFR < 10mL/min/1.73m2
  • ST-elevation myocardial infarction
  • Patient is not expected to survive to hospital discharge

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Decision aid intervention

Patients in this group will receive care from their physician incorporating the use of the decision aid.

no intervention: Usual Care

Patients in this group will receive usual care from their physician without the use of the decision aid.

Interventions

Decision aid

Decision aid for use by physicians and patients with CKD when deciding upon an invasive vs a conservative approach to management of coronary artery disease.

Primary outcome measure

  • Decisional Conflict Scale (O'Connor -8 question) [ Time Frame: Following patient-physician encounter (within 2 weeks) ]
  • Patient Nine-item Shared Decision-Making Questionnaire (SDM-Q-9) [ Time Frame: Following patient-physician encounter (within 2 weeks) ]
  • Knowledge of Treatment Risks [ Time Frame: Following patient-physician encounter (within 2 weeks) ]
  • Accuracy of Risk Perception [ Time Frame: Following patient-physician encounter (within 2 weeks) ]
  • Value-Choice Congruence [ Time Frame: Following patient-physician encounter (within 2 weeks) ]

Central Contacts and Locations

Central contacts

Pantea Javaheri, MRSc

1 (403) 220 2465pantea.javaheri@ucalgary.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 0M9

More Information

Sponsor

University of Calgary

Last update posted

May 14, 2026

Last verified

Apr, 2026

Keywords

  • Decision aid
  • Shared decision making

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-14.