- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995381
Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis (N201902036)
September 17, 2019 updated by: Taipei Medical University Shuang Ho Hospital
Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis: A Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi-Chun Huang
- Phone Number: 1304 886-2-88490088
- Email: 12020@s.tmu.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan
- Shuang Ho Hospital, Taipei Medical University
-
Contact:
- Yi-Chun Huang
- Phone Number: 1304 886-2-22490088
- Email: 12020@s.tmu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DAs group
Shared decision making using decision aids
|
Shared decision making with decision aids
|
No Intervention: Control group
Standard oral explanation guided with booklets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional conflict
Time Frame: 1 hour before Angiography
|
Total score of decisional conflict scale
|
1 hour before Angiography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2019
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
June 21, 2019
First Submitted That Met QC Criteria
June 21, 2019
First Posted (Actual)
June 24, 2019
Study Record Updates
Last Update Posted (Actual)
September 19, 2019
Last Update Submitted That Met QC Criteria
September 17, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N201902036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Haemostatic Adverse Reaction
-
Galeno Desenvolvimento de Pesquisas ClínicasBiolab Sanus FarmaceuticaCompletedLidocaine Adverse Reaction | Prilocaine Adverse ReactionBrazil
-
University of Texas Southwestern Medical CenterRecruitingAnesthesia | Anesthesia; Reaction | Anesthesia Complication | Anesthesia; Adverse Effect | Propofol Adverse Reaction | Etomidate Adverse ReactionUnited States
-
Clinical Hospital Center ZemunWithdrawnBisoprolol Adverse Reaction | Nebivolol Adverse ReactionSerbia
-
The Leeds Teaching Hospitals NHS TrustLeeds Clinical Commissioning GroupRecruitingAdherence, Medication | Statin Adverse Reaction | Anticoagulant Adverse ReactionUnited Kingdom
-
Rigshospitalet, DenmarkUnknownAnalgesic Adverse Reaction | Gonad Regulating Hormone Adverse ReactionDenmark
-
PT Bio FarmaCenter for Child Health Universitas Gadjah Mada (CCH-PRO UGM; Cipto Mangunkusumo... and other collaboratorsRecruitingVaccine Adverse Reaction | Vaccine ReactionIndonesia
-
University of AberdeenRecruitingAnticholinergic Adverse ReactionUnited Kingdom
-
Alexandria UniversityCompleted
-
Seoul National University HospitalCompletedSedative Adverse ReactionKorea, Republic of
-
Universiti Kebangsaan Malaysia Medical CentreUnknownKetamine Adverse ReactionMalaysia
Clinical Trials on Decision aids
-
Taipei Medical University Shuang Ho HospitalCompleted
-
Taipei Medical University Shuang Ho HospitalUnknown
-
Taipei Medical University Shuang Ho HospitalCompleted
-
University of AarhusTrygFonden, DenmarkCompletedCardiovascular Disease | High Cholesterol
-
Shenzhen Maternity & Child Healthcare HospitalRecruitingLeiomyoma, Uterine | High-Intensity Focused Ultrasound Ablation | Patients Decision AidsChina
-
University of Colorado, DenverNational Institute on Aging (NIA)CompletedHospice | Hospice Decision Making | End-of-life Decision MakingUnited States
-
University of Massachusetts, BostonMassachusetts General Hospital; Foundation for Informed Medical Decision MakingCompleted
-
Taipei Medical University Shuang Ho HospitalUnknownRotavirus VaccinesTaiwan
-
University of California, Los AngelesFoundation for Informed Medical Decision MakingCompleted
-
University of Massachusetts, BostonMassachusetts General Hospital; Foundation for Informed Medical Decision MakingCompleted