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Self-Management Interventions After an ICD Shock

Primary Purpose

Implantable Defibrillator User, Stress Reaction, Ptsd

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Paced Self-Management (SPSM)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Implantable Defibrillator User focused on measuring implantable cardioverter defibrillator, ptsd, stress management

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1) ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA), 2) receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment; 3) able to read, speak and write English; 4) access to online resources and telephone for study duration. Exclusion Criteria: 1) current diagnosis of PTSD, schizophrenia or bipolar disorder; 2) Short BLESSED score >6 indicating cognitive dysfunction [73]; 3) age <18 years; 4) AUDIT-C score ≥4 for alcohol use [74]; and 5) regular non-medical use of illicit drugs

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SPSM intervention

usual care

Arm Description

Heart rate self monitoring Online shock management modules

standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor

Outcomes

Primary Outcome Measures

ICD Shock anxiety
Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.

Secondary Outcome Measures

Total daily physical activity(steps/day)
Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.
Depression
PHQ-9, 0-27. Higher is higher depression.
PTSD Symptoms
Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
Quality of Life-Physical and Mental
PROMIS Global v 2.0, 0-50. Higher is higher qol.
Self-Efficacy Expectation
Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
Outcome expectation, 0-90. Higher is higher OE.
OE Scale
Salivary cortisol
Cortisol in saliva, the range in humans varies. measured in pg/ml.
Feasibility
Feasibility will be measured using patient recruitment and contact rates (reach within 1-3 days of shock, number screened, eligible & enrolled, proportion eligible vs agree to participate). Each of these variables creates a number for the total study.
Acceptability
Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires & data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.
Safety
Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no.

Full Information

First Posted
September 1, 2023
Last Updated
September 7, 2023
Sponsor
University of Washington
Collaborators
East Carolina University, National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT06037785
Brief Title
Self-Management Interventions After an ICD Shock
Official Title
Biobehavioral Intervention to Reduce PTSD After ICD Shock
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
East Carolina University, National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implantable Defibrillator User, Stress Reaction, Ptsd, Stress Management, Social Cognitive Theory
Keywords
implantable cardioverter defibrillator, ptsd, stress management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPSM intervention
Arm Type
Experimental
Arm Description
Heart rate self monitoring Online shock management modules
Arm Title
usual care
Arm Type
No Intervention
Arm Description
standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor
Intervention Type
Behavioral
Intervention Name(s)
Self-Paced Self-Management (SPSM)
Intervention Description
(SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month.
Primary Outcome Measure Information:
Title
ICD Shock anxiety
Description
Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.
Time Frame
Baseline, 1, 6 months
Secondary Outcome Measure Information:
Title
Total daily physical activity(steps/day)
Description
Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.
Time Frame
Baseline, 1, 6 months
Title
Depression
Description
PHQ-9, 0-27. Higher is higher depression.
Time Frame
Baseline, 1, 6 months
Title
PTSD Symptoms
Description
Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
Time Frame
Baseline, 1, 6 months
Title
Quality of Life-Physical and Mental
Description
PROMIS Global v 2.0, 0-50. Higher is higher qol.
Time Frame
Baseline, 1, 6 months
Title
Self-Efficacy Expectation
Description
Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
Time Frame
Baseline, 1, 6 months
Title
Outcome expectation, 0-90. Higher is higher OE.
Description
OE Scale
Time Frame
Baseline, 1, 6 months
Title
Salivary cortisol
Description
Cortisol in saliva, the range in humans varies. measured in pg/ml.
Time Frame
Baseline, 1, 6 months
Title
Feasibility
Description
Feasibility will be measured using patient recruitment and contact rates (reach within 1-3 days of shock, number screened, eligible & enrolled, proportion eligible vs agree to participate). Each of these variables creates a number for the total study.
Time Frame
6 months
Title
Acceptability
Description
Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires & data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.
Time Frame
6 months
Title
Safety
Description
Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA), 2) receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment; 3) able to read, speak and write English; 4) access to online resources and telephone for study duration. Exclusion Criteria: 1) current diagnosis of PTSD, schizophrenia or bipolar disorder; 2) Short BLESSED score >6 indicating cognitive dysfunction [73]; 3) age <18 years; 4) AUDIT-C score ≥4 for alcohol use [74]; and 5) regular non-medical use of illicit drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia M Dougherty, ARNP, PhD
Phone
206 221-7927
Email
cindyd@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia M Dougherty, ARNP, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
To support efforts by other researchers in replicating this study, and clinicians and healthcare systems to implement the interventions, we will 1) share the detailed study protocol, patient provider intervention materials, measures, and tools; 2) share a de-identified dataset.
IPD Sharing Time Frame
1 year after trial completion, available for up to 5 years after trial completion
IPD Sharing Access Criteria
Contact PI
IPD Sharing URL
https://nursing.uw.edu/person/cynthia-dougherty/

Learn more about this trial

Self-Management Interventions After an ICD Shock

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