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

T

Taipei Medical University

Status

Unknown

Conditions

Haemostatic Adverse Reaction

Treatments

Other: Decision aids

Study type

Interventional

Funder types

Other

Identifiers

NCT03995381
N201902036

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

DAs group
Experimental group
Description:
Shared decision making using decision aids
Treatment:
Other: Decision aids
Control group
No Intervention group
Description:
Standard oral explanation guided with booklets

Trial contacts and locations

1

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Central trial contact

Yi-Chun Huang

Data sourced from clinicaltrials.gov

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