Coronary OcclusionNCT02963584
Decision Aid in Chronic Total Occlusion (CTO) Patients
A study testing decision aid in people with Coronary Occlusion, run by The First Affiliated Hospital of Dalian Medical University.
Trial summary
The aim of this study is to assess the feasibility and validity of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Occlusion
- What is being tested?
- decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least one lesion occluding the coronary artery detected by angiography or MSCTA.
- left ventricular ejection fraction ≥ 40% on transthoracic echocardiography measurement.
- No major barriers to provide written consent.
- Doctors who work in the department of Cardiology for more than 1 years.
- No major barriers to provide written consent.
Who cannot join
- Severe coexisting conditions, such as severe renal insufficiency (GFR < 30 ml/min•1.73m2), severe hepatic dysfunction [elevated glutamic-pyruvic transaminase or glutamic-oxal acetic transaminase level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
- Patients with cognitive impairment, severe hearing loss, or visual impairment who could not complete the survey.
- Cardiologist:
- None.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Randomized Trial of a Decision Aid in CTO Patients
The aim of this study is to assess the feasibility and validity of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.
Read the detailed description
This is a parallel, 2-arm, randomized trial to compare an intervention group receiving CTO Choice (decision aid) to a control group receiving usual primary care. 100 patients and 60 cardiologists will be randomize by computer. The investigators will measure the effect of CTO Choice on five outcomes: (a) patient knowledge regarding CTO of PCI or medication (risk and benefit); (b) quality of the decision making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of percutaneous coronary intervention (PCI) or medication; and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, the investigators will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians exposed to the decision aid were able to recreate elements of the decision aid which control patients.
- Conditions
- Coronary Occlusion
- Being tested
- decision aid
- Keywords
- chronic total occlusion, decision aid
- Medical subject headings
- Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decision aidOther
The related information about CTO and PCI procedures will be told to the patients thoroughly.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Patients in this group will receive CTO Choice (decision aid). Receives: Other: decision aid |
| control group | No intervention | Patients in this group will receive usual primary care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient knowledge regarding CTO of PCI or medication (risk and benefit)
Measured: within the first 3 days after survey
Secondary outcomes (4)
quality of the decision making process for both the study subjects
Measured: within the first 3 days after survey
subjects acceptability with the decision aid
Measured: within the first 3 days after survey
rate of PCI or medication
Measured: within the first 3 days after survey
ability to recruit participants
Measured: within the first 3 days after survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary OcclusionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, First Hospital of China Medical University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Rongchong Huang, M.D., Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963584
- Sponsor's protocol ID
- LCKY2015-22-2
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of a Decision Aid in CTO Patients
- ClinicalTrials.gov ID
- NCT02963584
- Acronym / sponsor ID
- LCKY2015-22-2
- Conditions
- Coronary Occlusion
- Keywords
- chronic total occlusion, decision aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, First Hospital of China Medical University, Guangdong Provincial People's Hospital, Nanfang Hospital, Southern Medical University
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Nov 2016 (estimated)
- 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.
The aim of this study is to assess the feasibility and validity of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.
Detailed description
This is a parallel, 2-arm, randomized trial to compare an intervention group receiving CTO Choice (decision aid) to a control group receiving usual primary care. 100 patients and 60 cardiologists will be randomize by computer. The investigators will measure the effect of CTO Choice on five outcomes: (a) patient knowledge regarding CTO of PCI or medication (risk and benefit); (b) quality of the decision making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of percutaneous coronary intervention (PCI) or medication; and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, the investigators will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians exposed to the decision aid were able to recreate elements of the decision aid which control patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: decision aidPatients in this group will receive CTO Choice (decision aid). |
| control group | No intervention | –Patients in this group will receive usual primary care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least one lesion occluding the coronary artery detected by angiography or MSCTA.
- left ventricular ejection fraction ≥ 40% on transthoracic echocardiography measurement.
- No major barriers to provide written consent.
- Doctors who work in the department of Cardiology for more than 1 years.
- No major barriers to provide written consent.
Key exclusion criteria (4 listed)
- Severe coexisting conditions, such as severe renal insufficiency (GFR < 30 ml/min•1.73m2), severe hepatic dysfunction [elevated glutamic-pyruvic transaminase or glutamic-oxal acetic transaminase level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
- Patients with cognitive impairment, severe hearing loss, or visual impairment who could not complete the survey.
- None.
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 aidThe related information about CTO and PCI procedures will be told to the patients thoroughly. | Other | intervention group |
Primary outcome
patient knowledge regarding CTO of PCI or medication (risk and benefit)
Time frame: within the first 3 days after survey
4 secondary outcomes
quality of the decision making process for both the study subjects
Time frame: within the first 3 days after survey
subjects acceptability with the decision aid
Time frame: within the first 3 days after survey
rate of PCI or medication
Time frame: within the first 3 days after survey
ability to recruit participants
Time frame: within the first 3 days after survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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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. This study is not recruiting at the moment.
Rongchong Huang, M.D. principal investigator
The First Affiliated Hospital of Dalian Medical University
Questions about this trial
What is this clinical trial studying?
A study testing decision aid in people with Coronary Occlusion, run by The First Affiliated Hospital of Dalian Medical University.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongchong Huang, M.D. (+86 411 83635963 ext. 7127, rchuang@dlmedu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient knowledge regarding CTO of PCI or medication (risk and benefit) (time frame: within the first 3 days after survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2016.