Sudden Cardiac ArrestPhase 1NCT00226681
Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)
A Phase 1 study testing Nursing Telephone Support Protocol in people with Sudden Cardiac Arrest, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- Nursing Telephone Support Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Aug 2004
- Phase
- Phase 1
- 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 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First time sudden cardiac arrest with ICD implantation during hospitalization, over age 21 years, working telephone in the home, deliverable address for 1 year
Who cannot join
- Receiving an ICD for primary prevention of sudden cardiac arrest, inability to read, speak, or understand English, no telephone at home or no current address, cognitive or physical impairments that prohibited ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nursing Interventions Following Sudden Cardiac Arrest
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
Read the detailed description
This study is one of the first large randomized clinical trials of nursing interventions aimed at improving health outcomes after receiving an ICD. Written informed consent was used in the study.
- Conditions
- Sudden Cardiac Arrest
- Being tested
- Nursing Telephone Support Protocol, Usual Care
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Telephone Support ProtocolBehavioural
Usual CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Nursing Telephone Support Protocol |
| 2 | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
Measured: Baseline, 1- and 3-months from implantation
Secondary outcomes (4)
Improved physical functioning
Measured: Baseline, 1- and 3-months from implantation
Improved psychological adjustment
Measured: Baseline, 1- and 3-months from implantation
Improved self-efficacy
Measured: Baseline, 1- and 3-months from implantation
Lower health care use
Measured: Baseline, 1- and 3-months from implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startSep 1999
- Primary completionAug 2004
- Study completionAug 2004
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 Sudden Cardiac ArrestStudies 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 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Cynthia Dougherty, ARNP, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226681
- Sponsor's protocol ID
- 4766
- Other IDs
- R01NR004766
- Status last verified
- Sep 2008
- First submitted
- 23 Sep 2005
- Last updated
- 10 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dougherty CM, Lewis FM, Thompson EA, Baer JD, Kim W. Short-term efficacy of a telephone intervention by expert nurses after an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2004 Dec;27(12):1594-602. doi: 10.1111/j.1540-8159.2004.00691.x.
PubMed 15613121
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Interventions Following Sudden Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00226681
- Acronym / sponsor ID
- 4766
- Conditions
- Sudden Cardiac Arrest
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Sep 1999
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 27 Sep 2005 (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.
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
Detailed description
This study is one of the first large randomized clinical trials of nursing interventions aimed at improving health outcomes after receiving an ICD. Written informed consent was used in the study.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Nursing Telephone Support Protocol |
| 2 | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First time sudden cardiac arrest with ICD implantation during hospitalization, over age 21 years, working telephone in the home, deliverable address for 1 year
Key exclusion criteria (1 listed)
- Receiving an ICD for primary prevention of sudden cardiac arrest, inability to read, speak, or understand English, no telephone at home or no current address, cognitive or physical impairments that prohibited ability to give informed consent.
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 |
|---|---|---|
| Nursing Telephone Support Protocol | Behavioural | 1 |
| Usual Care | Behavioural | 2 |
Primary outcome
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
Time frame: Baseline, 1- and 3-months from implantation
4 secondary outcomes
Improved physical functioning
Time frame: Baseline, 1- and 3-months from implantation
Improved psychological adjustment
Time frame: Baseline, 1- and 3-months from implantation
Improved self-efficacy
Time frame: Baseline, 1- and 3-months from implantation
Lower health care use
Time frame: Baseline, 1- and 3-months from implantation
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 10 Sep 2008.
- Background: PubMed 15613121Dougherty CM, Lewis FM, Thompson EA, Baer JD, Kim W. Short-term efficacy of a telephone intervention by expert nurses after an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2004 Dec;27(12):1594-602. doi: 10.1111/j.1540-8159.2004.00691.x.
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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.
Cynthia Dougherty, ARNP, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nursing Telephone Support Protocol in people with Sudden Cardiac Arrest, run by National Institute of Nursing Research (NINR) at 1 site in United States.
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 10 Sep 2008. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD (time frame: Baseline, 1- and 3-months from implantation). 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 NCT00226681, 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 10 Sep 2008.