Decision Aid in Chronic Total Occlusion (CTO) Patients | NCT02963584

Studies
Decision Aid in Chronic Total Occlusion (CTO) Patients

NCT02963584

Sponsor

The First Affiliated Hospital of Dalian Medical University

Status

Unknown status

Last Update Posted

Nov 15, 2016Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Coronary Occlusion

Interventions

decision aid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Oct 27, 2016

First Submission Date that Met QC Criteria

Nov 14, 2016

First Posted Date

Nov 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2016

Last Update Posted Date

Nov 15, 2016Estimated

Name	Class
Beijing Anzhen Hospital	OTHER
First Hospital of China Medical University	OTHER
Guangdong Provincial People's Hospital	OTHER
Nanfang Hospital, Southern Medical University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental	Patients in this group will receive CTO Choice (decision aid).	Other: decision aid
control group	No Intervention	Patients in this group will receive usual primary care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
decision aid	Other	The related information about CTO and PCI procedures will be told to the patients thoroughly.	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient knowledge regarding CTO of PCI or medication (risk and benefit)		within the first 3 days after survey

Secondary Outcomes

Measure	Description	Time Frame
quality of the decision making process for both the study subjects		within the first 3 days after survey
subjects acceptability with the decision aid		within the first 3 days after survey

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patient:

Inclusion Criteria:

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.

Exclusion Criteria:

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:

Inclusion Criteria:

Doctors who work in the department of Cardiology for more than 1 years.
No major barriers to provide written consent.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rongchong Huang, M.D.	Contact	+86 411 83635963	7127	rchuang@dlmedu.edu.cn

Overall Officials

Name	Affiliation	Role
Rongchong Huang, M.D.	The First Affiliated Hospital of Dalian Medical University	Principal Investigator

Locations

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases