Decision Aid in Chronic Total Occlusion (CTO) Patients

NCT02963584 | Unknown

• 1 other identifier: LCKY2015-22-2
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Occlusion

Keywords

chronic total occlusion; decision aid

Outcome Measures

Primary Outcomes (1)

• patient knowledge regarding CTO of PCI or medication (risk and benefit)

  within the first 3 days after survey

Secondary Outcomes (4)

• 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

• rate of PCI or medication

  within the first 3 days after survey

• ability to recruit participants

  within the first 3 days after survey

Study Arms (2)

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

decision aid OTHER

The related information about CTO and PCI procedures will be told to the patients thoroughly.

intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Doctors who work in the department of Cardiology for more than 1 years.
• No major barriers to provide written consent.
• None.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead
• Beijing Anzhen Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

MeSH Terms

Conditions

Coronary Occlusion

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Rongchong Huang, M.D.

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongchong Huang, M.D.

CONTACT

+86 411 83635963; rchuang@dlmedu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 15, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-10