Nursing Interventions Following Sudden Cardiac Arrest

NCT ID: NCT04462887

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-01

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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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

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ICD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nursing intervention program

The nursing intervention program consisting of 3 parts: (1) Structural Informational (SI) booklet, (2) Nursing Telephone Support (NTS) protocol, and (3) Nurse Pager 24/7.

Group Type EXPERIMENTAL

Nursing intervention program

Intervention Type BEHAVIORAL

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.

Usual Care Group

Usual care participants received treatment as usual from their health care providers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nursing intervention program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Cynthia M. Dougherty

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia M. Dougherty, PhD, ARNP

Role: PRINCIPAL_INVESTIGATOR

University of Washington

References

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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.

Reference Type BACKGROUND
PMID: 11554535 (View on PubMed)

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.

Reference Type RESULT
PMID: 16359281 (View on PubMed)

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.

Reference Type RESULT
PMID: 15613121 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35948889 (View on PubMed)

Other Identifiers

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R01NR004766

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13730

Identifier Type: -

Identifier Source: org_study_id

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