Health BehaviorNCT01720121
Digital Videos Disc and Printed Guidelines and Improve the Knowledge of Patients Undergoing Cardiac Catheterization
A study testing Printed, digital video disc in people with Health Behavior, run by Instituto de Cardiologia do Rio Grande do Sul.
Trial summary
This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure: printed, digital video disc (DVD) conventional guidelines provide by nursing team Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Behavior
- What is being tested?
- Printed, digital video disc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Oct 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing the procedure were included, with age equal or superior to 18 years
Who cannot join
- patients who had already undergone previous procedures similar severe comorbidities, illiterate and who came to the facility to urgently
About this study
This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:
- printed,
- digital video disc (DVD)
- conventional guidelines provide by nursing team
Read the detailed description
This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:
- guidelines printed, (GOI) with informative material
- guidelines through a digital video disc (GDVD) six minutes
- conventional guidelines provide by nursing team
- Conditions
- Health Behavior
- Being tested
- Printed, digital video disc
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Printed, digital video discOther
The three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group received the guidelines orientation provide by nursing team |
| Guidelines printed group | Experimental | The patient received the informative material in details about the cardiac catheterization provide by the researchers Receives: Other: Printed, digital video disc |
| Guidelines digital video disc group | Experimental | Guidelines digital video disc group: The patient received the informative provide by digital video disc in details about the cardiac catheterization Receives: Other: Printed, digital video disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of knowledge about the procedure after orientation
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eneida R Rabelo da Silva, Professor, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720121
- Sponsor's protocol ID
- UP 4250.08
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Videos Disc and Printed Guidelines and Improve the Knowledge of Patients Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT01720121
- Acronym / sponsor ID
- UP 4250.08
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 2 Nov 2012 (estimated)
- 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.
This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:
- printed,
- digital video disc (DVD)
- conventional guidelines provide by nursing team
Detailed description
This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:
- guidelines printed, (GOI) with informative material
- guidelines through a digital video disc (GDVD) six minutes
- conventional guidelines provide by nursing team
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group received the guidelines orientation provide by nursing team |
| Guidelines printed group | Experimental | Other: Printed, digital video discThe patient received the informative material in details about the cardiac catheterization provide by the researchers |
| Guidelines digital video disc group | Experimental | Other: Printed, digital video discGuidelines digital video disc group: The patient received the informative provide by digital video disc in details about the cardiac catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing the procedure were included, with age equal or superior to 18 years
Key exclusion criteria (1 listed)
- patients who had already undergone previous procedures similar severe comorbidities, illiterate and who came to the facility to urgently
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 |
|---|---|---|
| Printed, digital video discThe three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team. | Other | Guidelines digital video disc group, Guidelines printed group |
Primary outcome
improvement of knowledge about the procedure after orientation
Time frame: four months
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 2 Nov 2012.
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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.
Eneida R Rabelo da Silva, Professor principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Printed, digital video disc in people with Health Behavior, run by Instituto de Cardiologia do Rio Grande do Sul.
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 1 inclusion and 1 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 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
improvement of knowledge about the procedure after orientation (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2012.