Cardiac Implantable Electronic DeviceNCT05688540
Efficiency of Electronic Multimedia Intervention With the Cardiac Implantable Electronic Device.
A study testing e book and traditional education booklet in people with Cardiac Implantable Electronic Device, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 93 years
- Conditions the study is for
- Cardiac Implantable Electronic Device
- What is being tested?
- e book and traditional education booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Feb 2019to 18 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- TDS > score 19 (Severely depressed patient)
- Patient of terminal stage cancer.
- Patient with delirium during hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Electronic Multimedia Intervention on Quality of Life, Psychological Adjustment and Depression in Patients With the Cardiac Implantable Electronic Device
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.
Read the detailed description
Arrhythmia is defined an abnormality in the heart transmission system related to heartbeat or heart rhythm problem (Li et al., 2017). Most of arrhythmia could diagnosed and treated effectively, including medication, cardiac implantable electronic device (CIED) and operation. Many patients have uncertainty about the implantation process, the results and possible complications after CIED, the lack of understanding about further progress of their disease, the change of lifestyle and the accident of electronic shock. Those causes are the physical and mental negative impacts on patient which makes anxiety or depressed and turn affects the quality of life.
At present, there are few clinical models for CIED utilizing electronic multi-media in Taiwan. The use of multi-media models may integrate clinical care and health education for helping patients to learn disease and care, also through vivid video and multi-media, we may make a clear education of disease causes, treatment and relevant care knowledges which are alleviate the uncertainty factors from patients (Hsueh et al., 2016). Therefore, the more overall understanding before CIED intervention, the more helpful to quality of living and psychological adjustment of the patient.
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.
keywords：Cardiac Implantable Electronic Device、arrhythmia、electronic multimedia、quality of life、psychological adjustment、depression
- Conditions
- Cardiac Implantable Electronic Device
- Being tested
- e book, traditional education booklet
- Keywords
- cardiac implantable electronic device, quality of life, electronic multimedia, psychological adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e bookOther
e book
traditional education bookletOther
traditional education booklet
| Study group | Role | What they receive |
|---|---|---|
| e book | Experimental | a multi-media model through e-book for preoperative care of CIED intervention. Receives: Other: e book |
| traditional education booklet | Experimental | traditional education booklet of CIED intervention. Receives: Other: traditional education booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20mins
Chinese 14-item PSS
14 questions totally for measuring the stress of patient in a month.
Measured: 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.
Measured: 10mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start19 Feb 2019
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Implantable Electronic DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Responsible party
- Principal investigator, Miao Yen Chen, National Taipei University of Nursing and Health Sciences
- Investigators
- Yen Chen CHEN, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688540
- Sponsor's protocol ID
- 18MMHIS006e
- Status last verified
- Nov 2023
- First submitted
- 7 Jan 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28180011
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Electronic Multimedia Intervention on Quality of Life, Psychological Adjustment and Depression in Patients With the Cardiac Implantable Electronic Device
- ClinicalTrials.gov ID
- NCT05688540
- Acronym / sponsor ID
- 18MMHIS006e
- Conditions
- Cardiac Implantable Electronic Device
- Keywords
- cardiac implantable electronic device, quality of life, electronic multimedia, psychological adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Arrhythmia is defined an abnormality in the heart transmission system related to heartbeat or heart rhythm problem (Li et al., 2017). Most of arrhythmia could diagnosed and treated effectively, including medication, cardiac implantable electronic device (CIED) and operation. Many patients have uncertainty about the implantation process, the results and possible complications after CIED, the lack of understanding about further progress of their disease, the change of lifestyle and the accident of electronic shock. Those causes are the physical and mental negative impacts on patient which makes anxiety or depressed and turn affects the quality of life.
At present, there are few clinical models for CIED utilizing electronic multi-media in Taiwan. The use of multi-media models may integrate clinical care and health education for helping patients to learn disease and care, also through vivid video and multi-media, we may make a clear education of disease causes, treatment and relevant care knowledges which are alleviate the uncertainty factors from patients (Hsueh et al., 2016). Therefore, the more overall understanding before CIED intervention, the more helpful to quality of living and psychological adjustment of the patient.
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.
keywords：Cardiac Implantable Electronic Device、arrhythmia、electronic multimedia、quality of life、psychological adjustment、depression
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e book | Experimental | Other: e booka multi-media model through e-book for preoperative care of CIED intervention. |
| traditional education booklet | Experimental | Other: traditional education booklettraditional education booklet of CIED intervention. |
Who may qualify
- Ages
- 20 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- TDS > score 19 (Severely depressed patient)
- Patient of terminal stage cancer.
- Patient with delirium during hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e booke book | Other | e book |
| traditional education booklettraditional education booklet | Other | traditional education booklet |
Primary outcome
WHOQOL-BREF(TW)
Time frame: 20mins
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.
Chinese 14-item PSS
Time frame: 10mins
14 questions totally for measuring the stress of patient in a month.
Taiwan Depression Scale
Time frame: 10mins
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 28180011Abbasi 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.
- Individual participant dataSharing planned: No
Related trials for Cardiac Implantable Electronic Device
Active, not recruitingObservational study
EValuation of prognostIc and Cost reDuction by tElemonitoring iN CIEDs Usual carE: an Updated Analysis Using 2019-2023 Data
Cardiovascular Diseases (CVD), Cardiac Implantable Electronic Device (CIED)
RecruitingObservational study
Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation
RecruitingPhase 3
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
Endocarditis, Bacterial
Not yet recruiting
Cardiac Anodal Biphasic Pacing
Cardiac Pacing
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Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
Postoperative Care After Cardiac Implantable Electronic Device Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen Chen CHEN, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e book and traditional education booklet in people with Cardiac Implantable Electronic Device, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHOQOL-BREF(TW) (time frame: 20mins). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05688540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.