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Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis (N201902036)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03995381
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Taipei Medical University Shuang Ho Hospital

Brief Summary:
Vascular closure device, hemostatic bandage and manual compression can achieve hemostasis after angiographic examination. These three methods of hemostasis changed the rate of hemostasis, early ambulation, hematoma , hemostasis failure rate, and expense. Therefore, shared decision making (SDM) is necessary to aid patients to choose hemostasis.The investigators have developed a decision aids (DA) and planned a randomized controlled trial (RCT) to evaluate its impact on angiographic patients. The measurements include a battery of interview-based questionnaires and evaluations of decision conflicts. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and choice conflicts.during and after thier Hemostasis procedure.

Condition or disease Intervention/treatment Phase
Haemostatic Adverse Reaction Other: Decision aids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis: A Randomized Controlled Trial
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: DAs group
Shared decision making using decision aids
Other: Decision aids
Shared decision making with decision aids

No Intervention: Control group
Standard oral explanation guided with booklets

Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: 1 hour before Angiography ]
    Total score of decisional conflict scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who needs an angiographic examination or treatment.
  • Patients with angiographic indications
  • Patients who were able to give consent and complete the interview

Exclusion Criteria:

  • The angiographic procedure uses patients with a catheter size more than 7fr.
  • Patients in critical situations requiring urgent treatment
  • Patients had cognitive impairment
  • Patients were physically unfit to be interviewed
  • Patients were non-Mandarin or -Taiwanese

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03995381

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Contact: Yi-Chun Huang 886-2-88490088 ext 1304

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Shuang Ho Hospital, Taipei Medical University
New Taipei City, Taiwan
Contact: Yi-Chun Huang    886-2-22490088 ext 1304   
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
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Responsible Party: Taipei Medical University Shuang Ho Hospital Identifier: NCT03995381    
Other Study ID Numbers: N201902036
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University Shuang Ho Hospital: