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ICDNCT04462887

Nursing Interventions Following Sudden Cardiac Arrest

A study testing Nursing intervention program in people with ICD, run by University of Washington.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Determine the benefits of implantable cardioverter defibrillator (ICD) patients participating in a structured, 8-week educational telephone intervention delivered by expert cardiovascular nurses post-ICD. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
ICD
What is being tested?
Nursing intervention program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
No sites listed yet
Study dates
1 Jan 1998to 31 Dec 2003
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • the ability to read, speak, and write English,
  • having telephone access,
  • willingness to be followed for 1 year.

Who cannot join

  • significant clinical comorbidities that prevented their return home after hospitalization,
  • younger than 21 years of age,
  • Short BLESSED cognitive screening tool scores ≥10.

About this study

Official title: Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest

Determine the benefits of implantable cardioverter defibrillator (ICD) patients participating in a structured, 8-week educational telephone intervention delivered by expert cardiovascular nurses post-ICD. To determine if individuals participating in a post-hospital telephone nursing intervention would demonstrate (1) increased physical functioning, (2) increased psychological adjustment, (3) improved self-efficacy in managing the challenges of ICD recovery, and (4) lower levels of health care utilization over usual care at 1, 3, 6 and 12 months post-ICD implantation.

Read the detailed description

The goal of the study was to determine if a short-term social cognitive theory intervention would improve physical functioning and enhance psychological adjustment after receiving a first time ICD. The central aim of this study was to determine if individuals participating in a telephone nursing intervention compared to usual care demonstrated (1) improved physical functioning, (2) improved psychological adjustment, 3) improved knowledge related to sudden cardiac arrest (SCA) and the ICD, and (4) lower levels of health care use over a 3-month period post-ICD.

Conditions
ICD
Being tested
Nursing intervention program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing intervention programBehavioural

    The intervention consisted of structured information (SI) provided in a booklet, nursing telephone support (NTS) and access to a nurse pager 24h/day. The SI booklet, Sudden Cardiac Arrest: A Survivor's Experience, contains 2 components: a descriptive component including individual verbatim statements about experiences of others during the first year of recovery and a management component outlining successful strategies used by others in dealing with issues in recovery. The NTS telephone calls included: check-in about current concerns, assessment of the topic for the week, review of common recovery experiences, discussion of behavioral strategies for dealing with the topic for the week, provision of positive feedback for strategies already working well, anxiety reduction statements, practice of new behaviors using role-playing and problem solving techniques, summarization, setting specific goals for the upcoming week, and collaborating on a learning assignment for the subsequent week.

Study groups in NCT04462887
Study groupRoleWhat they receive
Nursing intervention programExperimentalThe nursing intervention program consisting of 3 parts: (1) Structural Informational (SI) booklet, (2) Nursing Telephone Support (NTS) protocol, and (3) Nurse Pager 24/7.
Receives: Behavioral: Nursing intervention program
Usual Care GroupNo interventionUsual care participants received treatment as usual from their health care providers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Concerns Assessment (PCA)

    scores from 0 to 58 in which lower scores reflect fewer symptoms

    Measured: Change in patient concerns from baseline to 12 months

  2. SF-12 Short Form Health Survey (SF-12)

    scores from 0 to 100 with higher scores representing better self-reported health

    Measured: change in general health (SF-12) score from baseline to 12 months

  3. State-Trait Anxiety Inventory (STAI)

    Scores range from 20 to 80. Higher scores indicating greater anxiety.

    Measured: change in anxiety (STAI) score from baseline to 12 months

Secondary outcomes (9)

  1. Number of ICD shocks

    The number of ICD shocks (if any) that the patient received from the ICD

    Measured: change in number of ICD shocks from baseline to 12 months

  2. Center for Epidemiologic Studies Depression Scale (CES-D)

    Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

    Measured: change in depression (CES-D) score from baseline to 12 months

  3. Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)

    SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The first 8 items measure self-efficacy. Score for this sub-scale ranges from 0 to 8. higher the score greater is the self-efficacy.

    Measured: change in efficacy expectations from baseline to 12 months

  4. Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias

    The number of times a person went to the ER for evaluation over 12 months

    Measured: change in number of ER visits from baseline to 12 months

  5. Number of clinic visits related to the ICD

    The number of times a person had an outpatient clinic visit for the ICD

    Measured: change in number of clinic visits from baseline to 12 months

  6. Number of hospital admissions for ICD or cardiac related

    The number of times a person stayed overnight, at least 24 hours, in the hospital.

    Measured: change in number of hospital admission from baseline to 12 months

  7. Sudden Cardiac Arrest (SCA) Knowledge

    Score ranges from 0 to 25. Higher the score greater is the ICD knowledge.

    Measured: change in SCA knowledge from baseline to 12 months

  8. Heart rhythm stability

    self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits

    Measured: change in heart rhythm stability from baseline to 12 months

  9. Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)

    SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The items - to 16 measure self-management behavior. Score range from 0 to 8 for self-management behavior skills. Higher the score greater is the self-management behavior skills.

    Measured: change in self-management behavior from baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start1 Jan 1998
  3. Primary completion31 Dec 2003
  4. Study completion31 Dec 2003

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04462887
Sponsor's protocol ID
13730
Other IDs
R01NR004766
Status last verified
Jul 2020
First submitted
16 Jun 2020
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dougherty CM, Johnson-Crowley NR, Lewis FM, Thompson EA. Theoretical development of nursing interventions for sudden cardiac arrest survivors using social cognitive theory. ANS Adv Nurs Sci. 2001 Sep;24(1):78-86. doi: 10.1097/00012272-200109000-00009.

    PubMed 11554535

  • Dougherty CM, Thompson EA, Lewis FM. Long-term outcomes of a telephone intervention after an ICD. Pacing Clin Electrophysiol. 2005 Nov;28(11):1157-67. doi: 10.1111/j.1540-8159.2005.09500.x.

    PubMed 16359281

  • 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

  • Dougherty CM, Liberato ACS, Streur MM, Burr RL, Kwan KY, Zheng T, Auld JP, Thompson EA. Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial. BMC Cardiovasc Disord. 2022 Aug 10;22(1):369. doi: 10.1186/s12872-022-02782-8.

    PubMed 35948889

Questions about this trial

What is this clinical trial studying?

A study testing Nursing intervention program in people with ICD, run by University of Washington.

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 3 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 8 Jul 2020. 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?

Patient Concerns Assessment (PCA) (time frame: Change in patient concerns from baseline to 12 months). 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 NCT04462887, which also lists 4 linked publications.

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 8 Jul 2020.

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