Chronic Kidney DiseaseMyHeart&CKDNCT06920927
Feasibility and Pilot Testing of "My Heart and CKD" Online Shared Decision Aid
A study testing Decision aid in people with Chronic Kidney Disease and Coronary Artery Disease, run by University of Calgary at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Coronary Artery Disease
- What is being tested?
- Decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Bryan Har, MD, MSc.
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 0M9
Michelle Graham, MD
About this study
Official title: Feasibility and Pilot Testing of the "My Heart and CKD" Online Shared Decision Aid
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.
Read the detailed description
Heart disease is a common comorbidity in individuals with chronic kidney disease (CKD). However, patients with CKD are 20-50% less likely to receive heart tests and treatments for acute coronary syndromes and there is also substantial variability in management for patient with CKD and stable coronary disease. The variability and disparities in care for people with CKD are attributed to three common obstacles: concern over potential kidney function deterioration from procedures, limited understanding of the benefits and risks of invasive versus medical treatment approaches for individual patients with CKD, and inadequate strategies to align treatment decisions with patient values and preferences. Addressing these barriers necessitates a shift towards patient-centered care and informed decision-making in cardiovascular and kidney care. Offering personalized risk information and decision support to patients with CKD and their care providers could help surmount these obstacles. These patient-oriented approaches to heart disease care require weighing treatment decisions' risks and benefits through informed discussions between patients and providers.
Shared decision-making (SDM), a collaborative approach between patients and healthcare providers, integrates clinical knowledge with patient values, preferences, and risk tolerance to personalize care decisions. SDM, when integrated into care practices, enhances patient satisfaction and experiences. However, despite its benefits, only a minority of Canadian patients report experiencing SDM, highlighting the need for its broader implementation.
Patient decision aids (PDAs) are tools for facilitating collaborative medical decisions, particularly when multiple treatment options exist. PDAs equip patients with information on treatment choices, associated risks, and benefits, and help them clarify their values in the decision-making process. A Cochrane Systematic Review highlighted that when utilized, PDAs enhance patient knowledge, ensure informed decision-making, and foster active patient involvement in the decision process. Guideline frameworks like the International Patient Decision Aid Standards (IPDAS) and Ottawa Framework ensure the rigor and standardization of PDA development.
Trial Objectives:
This study will implement and evaluate a decision aid for use by patients with CKD and heart disease and their healthcare providers when making treatment decisions for coronary artery disease, including with acute coronary syndrome and stable coronary artery disease.
Specific objectives are:
- To measure the effectiveness of delivery of personalized information for patients with CKD and heart disease and their health care providers within clinical care. The investigators will measure use and completion of the decision-aid during clinical care encounters for management of heart disease within an implementation pilot trial. Quantitative and qualitative methods will be used to measure how effectively the decision aid conveys personalized information. The investigators will also examine how closely management decisions correlate with risk estimates for patients who received the decision aid. Measures from patients with and without use of the decision aid will be compared using a cluster randomized, pre- versus post-implementation, design, to evaluate effectiveness.
- To work towards better recognition of patient preferences and their incorporation into decision making, the investigators will measure the knowledge, experience, and satisfaction of patients who receive the decision-aid within the implementation pilot trial. The investigators will compare the expressed preferences of patients to the management approach that patients received and determine whether greater concordance is achieved using the decision aid than observed in the absence of a decision aid.
- To examine the decision aid's effects on awareness, understanding, and incorporation of shared decision-making practices, the investigators will survey and interview health care providers on knowledge and confidence with shared decision-making before and after use of the decision aid. The investigators will also measure the decisional conflict of patients who received the decision aid and those who did not, which is an outcome measure that has been shown to improve with interventions that support shared decision-making.
Primary objective: Conduct an implementation pilot study in Canada, deploying the decision aid accompanied by implementation training and resources for culturally sensitive shared decision-making within clinical care.
Secondary objective: To document and evaluate the feasibility, acceptability, and satisfaction with use of the decision aid.
- Conditions
- Chronic Kidney Disease, Coronary Artery Disease
- Being tested
- Decision aid
- Keywords
- Decision aid, Shared decision making
- Medical subject headings
- Renal Insufficiency, Chronic, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid intervention | Experimental | Patients in this group will receive care from their physician incorporating the use of the decision aid. Receives: Other: Decision aid |
| Usual Care | No intervention | Patients in this group will receive usual care from their physician without the use of the decision aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (O'Connor -8 question)
Patient's perceptions of modifiable factors contributing to uncertainty with their decision such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
Measured: Following patient-physician encounter (within 2 weeks)
Patient Nine-item Shared Decision-Making Questionnaire (SDM-Q-9)
Assessment of patient's perceived level of involvement in decision-making related to their own treatment.
Measured: Following patient-physician encounter (within 2 weeks)
Knowledge of Treatment Risks
Patient's knowledge of the risks of kidney failure versus a heart attack in the future associated with the treatment choices of invasive versus optimal medical management presented in the decision aid
Measured: Following patient-physician encounter (within 2 weeks)
Accuracy of Risk Perception
Whether a patient's perception of risk of the risk of kidney failure corresponds to the estimated risk of this outcome for a similar person receiving invasive management as presented in the decision aid
Measured: Following patient-physician encounter (within 2 weeks)
Value-Choice Congruence
Whether a patient's choice of invasive versus optimal medical management is consistent with their most important stated values
Measured: Following patient-physician encounter (within 2 weeks)
Secondary outcomes (6)
Preferred Choice
The patient's inclination towards a preferred choice of treatment with invasive versus conservative management
Measured: Following patient physician encounter (within 2 weeks) and 3 months later
Actual Choice
Whether invasive or optimal medical therapy was actually chosen by the patient and physician.
Measured: Following patient-physician encounter (within 2 weeks)
Adherence to Chosen Option
Whether the treatment received (invasive or medical therapy) remained the same as the initially chosen option
Measured: Three months following the patient-physician encounter
Decisional Regret Scale (O-Connor - 5 question)
Evaluation of feelings of dissatisfaction or disappointment following the decision, reflecting on whether the individual would make the same decision given the chance again
Measured: Three months following the patient-physician encounter
Acceptability Scale (O'Connor - 10 question)
Patient's rating of the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.
Measured: Following patient-physician encounter (within 2 weeks)
Physician Nine-item Shared Decision-Making Questionnaire (SDM-Q-9)
Assessment of physician's perceived level of patient involvement in decision-making related to their own treatment.
Measured: Following patient-physician encounter (within 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Dec 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster randomized stepped wedge design
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Matthew T James, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920927
- Sponsor's protocol ID
- REB22-0289
- Acronym
- MyHeart&CKD
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Maintenance of data privacy and security .
Publications
Wilson T, Javaheri P, Finlay J, Hazlewood G, Wilton SB, Sajobi T, Levin A, Pearson W, Connolly C, James MT. Treatment Preferences for Cardiac Procedures of Patients With Chronic Kidney Disease in Acute Coronary Syndrome: Design and Pilot Testing of a Discrete Choice Experiment. Can J Kidney Health Dis. 2021 Jan 27;8:2054358120985375. doi: 10.1177/2054358120985375. eCollection 2021.
PubMed 33552527Finlay J, Wilson T, Javaheri PA, Pearson W, Connolly C, Elliott MJ, Graham MM, Norris CM, Wilton SB, James MT. Patient and physician perspectives on shared decision-making for coronary procedures in people with chronic kidney disease: a patient-oriented qualitative study. CMAJ Open. 2020 Dec 10;8(4):E860-E868. doi: 10.9778/cmajo.20200039. Print 2020 Oct-Dec.
PubMed 33303572Wilson TA, Hazlewood GS, Sajobi TT, Wilton SB, Pearson WE, Connolly C, Javaheri PA, Finlay JL, Levin A, Graham MM, Tonelli M, James MT. Preferences of Patients With Chronic Kidney Disease for Invasive Versus Conservative Treatment of Acute Coronary Syndrome: A Discrete Choice Experiment. J Am Heart Assoc. 2023 Mar 21;12(6):e028492. doi: 10.1161/JAHA.122.028492. Epub 2023 Mar 9.
PubMed 36892063
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Pilot Testing of the "My Heart and CKD" Online Shared Decision Aid
- ClinicalTrials.gov ID
- NCT06920927
- Acronym / sponsor ID
- MyHeart&CKD / REB22-0289
- Conditions
- Chronic Kidney Disease, Coronary Artery Disease
- Keywords
- Decision aid, Shared decision making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta, Alberta Health services
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart disease is a common comorbidity in individuals with chronic kidney disease (CKD). However, patients with CKD are 20-50% less likely to receive heart tests and treatments for acute coronary syndromes and there is also substantial variability in management for patient with CKD and stable coronary disease. The variability and disparities in care for people with CKD are attributed to three common obstacles: concern over potential kidney function deterioration from procedures, limited understanding of the benefits and risks of invasive versus medical treatment approaches for individual patients with CKD, and inadequate strategies to align treatment decisions with patient values and preferences. Addressing these barriers necessitates a shift towards patient-centered care and informed decision-making in cardiovascular and kidney care. Offering personalized risk information and decision support to patients with CKD and their care providers could help surmount these obstacles. These patient-oriented approaches to heart disease care require weighing treatment decisions' risks and benefits through informed discussions between patients and providers.
Shared decision-making (SDM), a collaborative approach between patients and healthcare providers, integrates clinical knowledge with patient values, preferences, and risk tolerance to personalize care decisions. SDM, when integrated into care practices, enhances patient satisfaction and experiences. However, despite its benefits, only a minority of Canadian patients report experiencing SDM, highlighting the need for its broader implementation.
Patient decision aids (PDAs) are tools for facilitating collaborative medical decisions, particularly when multiple treatment options exist. PDAs equip patients with information on treatment choices, associated risks, and benefits, and help them clarify their values in the decision-making process. A Cochrane Systematic Review highlighted that when utilized, PDAs enhance patient knowledge, ensure informed decision-making, and foster active patient involvement in the decision process. Guideline frameworks like the International Patient Decision Aid Standards (IPDAS) and Ottawa Framework ensure the rigor and standardization of PDA development.
Trial Objectives:
This study will implement and evaluate a decision aid for use by patients with CKD and heart disease and their healthcare providers when making treatment decisions for coronary artery disease, including with acute coronary syndrome and stable coronary artery disease.
Specific objectives are:
- To measure the effectiveness of delivery of personalized information for patients with CKD and heart disease and their health care providers within clinical care. The investigators will measure use and completion of the decision-aid during clinical care encounters for management of heart disease within an implementation pilot trial. Quantitative and qualitative methods will be used to measure how effectively the decision aid conveys personalized information. The investigators will also examine how closely management decisions correlate with risk estimates for patients who received the decision aid. Measures from patients with and without use of the decision aid will be compared using a cluster randomized, pre- versus post-implementation, design, to evaluate effectiveness.
- To work towards better recognition of patient preferences and their incorporation into decision making, the investigators will measure the knowledge, experience, and satisfaction of patients who receive the decision-aid within the implementation pilot trial. The investigators will compare the expressed preferences of patients to the management approach that patients received and determine whether greater concordance is achieved using the decision aid than observed in the absence of a decision aid.
- To examine the decision aid's effects on awareness, understanding, and incorporation of shared decision-making practices, the investigators will survey and interview health care providers on knowledge and confidence with shared decision-making before and after use of the decision aid. The investigators will also measure the decisional conflict of patients who received the decision aid and those who did not, which is an outcome measure that has been shown to improve with interventions that support shared decision-making.
Primary objective: Conduct an implementation pilot study in Canada, deploying the decision aid accompanied by implementation training and resources for culturally sensitive shared decision-making within clinical care.
Secondary objective: To document and evaluate the feasibility, acceptability, and satisfaction with use of the decision aid.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized stepped wedge design
| Arm | Type | Receives |
|---|---|---|
| Decision aid intervention | Experimental | Other: Decision aidPatients in this group will receive care from their physician incorporating the use of the decision aid. |
| Usual Care | No intervention | –Patients in this group will receive usual care from their physician without the use of the decision aid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidDecision aid for use by physicians and patients with CKD when deciding upon an invasive vs a conservative approach to management of coronary artery disease. | Other | Decision aid intervention |
Primary outcome
Decisional Conflict Scale (O'Connor -8 question)
Time frame: Following patient-physician encounter (within 2 weeks)
Patient's perceptions of modifiable factors contributing to uncertainty with their decision such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
Patient Nine-item Shared Decision-Making Questionnaire (SDM-Q-9)
Time frame: Following patient-physician encounter (within 2 weeks)
Assessment of patient's perceived level of involvement in decision-making related to their own treatment.
Knowledge of Treatment Risks
Time frame: Following patient-physician encounter (within 2 weeks)
Patient's knowledge of the risks of kidney failure versus a heart attack in the future associated with the treatment choices of invasive versus optimal medical management presented in the decision aid
Accuracy of Risk Perception
Time frame: Following patient-physician encounter (within 2 weeks)
Whether a patient's perception of risk of the risk of kidney failure corresponds to the estimated risk of this outcome for a similar person receiving invasive management as presented in the decision aid
Value-Choice Congruence
Time frame: Following patient-physician encounter (within 2 weeks)
Whether a patient's choice of invasive versus optimal medical management is consistent with their most important stated values
6 secondary outcomes
Preferred Choice
Time frame: Following patient physician encounter (within 2 weeks) and 3 months later
Actual Choice
Time frame: Following patient-physician encounter (within 2 weeks)
Adherence to Chosen Option
Time frame: Three months following the patient-physician encounter
Decisional Regret Scale (O-Connor - 5 question)
Time frame: Three months following the patient-physician encounter
Acceptability Scale (O'Connor - 10 question)
Time frame: Following patient-physician encounter (within 2 weeks)
Physician Nine-item Shared Decision-Making Questionnaire (SDM-Q-9)
Time frame: Following patient-physician encounter (within 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 33552527Wilson T, Javaheri P, Finlay J, Hazlewood G, Wilton SB, Sajobi T, Levin A, Pearson W, Connolly C, James MT. Treatment Preferences for Cardiac Procedures of Patients With Chronic Kidney Disease in Acute Coronary Syndrome: Design and Pilot Testing of a Discrete Choice Experiment. Can J Kidney Health Dis. 2021 Jan 27;8:2054358120985375. doi: 10.1177/2054358120985375. eCollection 2021.
- Background: PubMed 33303572Finlay J, Wilson T, Javaheri PA, Pearson W, Connolly C, Elliott MJ, Graham MM, Norris CM, Wilton SB, James MT. Patient and physician perspectives on shared decision-making for coronary procedures in people with chronic kidney disease: a patient-oriented qualitative study. CMAJ Open. 2020 Dec 10;8(4):E860-E868. doi: 10.9778/cmajo.20200039. Print 2020 Oct-Dec.
- Background: PubMed 36892063Wilson TA, Hazlewood GS, Sajobi TT, Wilton SB, Pearson WE, Connolly C, Javaheri PA, Finlay JL, Levin A, Graham MM, Tonelli M, James MT. Preferences of Patients With Chronic Kidney Disease for Invasive Versus Conservative Treatment of Acute Coronary Syndrome: A Discrete Choice Experiment. J Am Heart Assoc. 2023 Mar 21;12(6):e028492. doi: 10.1161/JAHA.122.028492. Epub 2023 Mar 9.
- Shared Decision-Making for Heart and Kidney DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No. Maintenance of data privacy and security .
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew T James, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Chronic Kidney Disease and Coronary Artery Disease, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pantea Javaheri, MRSc (1 (403) 220 2465, pantea.javaheri@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (O'Connor -8 question) (time frame: Following patient-physician encounter (within 2 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920927, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.