Efficiency of Electronic Multimedia Intervention With the Cardiac Implantable Electronic Device.
1 other identifier
interventional
36
1 country
1
Brief Summary
In this study, we aim to design a multi-media model through e-book for preoperative care of CIED intervention, which can enhance the knowledges of patients, reducing the stresses and uncertainties before the intervention. Therefore, patient may reduce the psychological internalization after CIED intervention, also needs to track the impact of emotional depression, psychological adaption and life quality status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2022
CompletedFirst Submitted
Initial submission to the registry
January 7, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedNovember 9, 2023
November 1, 2023
3.1 years
January 7, 2023
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
WHOQOL-BREF(TW)
28 questions totally with four parts, including physical, mental, social-behavior related and environment aspects. The more score they get, means more quality of life they obtained.
20mins
Chinese 14-item PSS
14 questions totally for measuring the stress of patient in a month.
10mins
Taiwan Depression Scale
18 questions totally for testing how level of anxiety and depress of patient. The element of this scale are mental aspect, self-thought aspect and physical aspect.
10mins
Study Arms (2)
e book
EXPERIMENTALa multi-media model through e-book for preoperative care of CIED intervention.
traditional education booklet
EXPERIMENTALtraditional education booklet of CIED intervention.
Interventions
Eligibility Criteria
You may qualify if:
- Actual age \> 20 years-old adults.
- Patients are willing to participate in this research.
- Conscious clear, sanity, and be able to communicate with others in Mandarin or Taiwanese languages.
- Be able to operate mobile electronic device, such as mobile phone, iPAD or laptop; Families and healthcare provider allows to assist.
You may not qualify if:
- TDS \> score 19 (Severely depressed patient)
- Patient of terminal stage cancer.
- Patient with delirium during hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mackay Memorial Hospital
Taipei, 104, Taiwan
Related Publications (1)
Abbasi M, Negarandeh R, Norouzadeh R, Shojae Mogadam AR. The Challenges of Living With an Implantable Cardioverter Defibrillator: A Qualitative Study. Iran Red Crescent Med J. 2016 Jun 22;18(10):e25158. doi: 10.5812/ircmj.25158. eCollection 2016 Oct.
PMID: 28180011BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Yen Chen CHEN, PhD
National Taipei University of Nursing and Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN PhD Professor
Study Record Dates
First Submitted
January 7, 2023
First Posted
January 18, 2023
Study Start
February 19, 2019
Primary Completion
March 18, 2022
Study Completion
March 18, 2022
Last Updated
November 9, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share