Self-Management Interventions After an ICD Shock

• ClinicalTrials.gov Identifier: NCT06037785
• Recruitment Status: Not yet recruiting
• First Posted: September 14, 2023
• Last Update Posted: September 14, 2023
• Sponsor: University of Washington
• Collaborators: East Carolina University; National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Cynthia M. Dougherty, University of Washington

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.

Condition or disease	Intervention/treatment	Phase
Implantable Defibrillator User; Stress Reaction; Ptsd; Stress Management; Social Cognitive Theory	Behavioral: Self-Paced Self-Management (SPSM)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Biobehavioral Intervention to Reduce PTSD After ICD Shock
• Estimated Study Start Date: December 1, 2023
• Estimated Primary Completion Date: July 31, 2025
• Estimated Study Completion Date: July 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: SPSM intervention; Heart rate self monitoring Online shock management modules	Behavioral: Self-Paced Self-Management (SPSM); (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.
No Intervention: usual care; standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor

Outcome Measures

Primary Outcome Measures :

1. ICD Shock anxiety [ Time Frame: Baseline, 1, 6 months ]
   Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.

Secondary Outcome Measures :

1. Total daily physical activity(steps/day) [ Time Frame: Baseline, 1, 6 months ]
   Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.
2. Depression [ Time Frame: Baseline, 1, 6 months ]
   PHQ-9, 0-27. Higher is higher depression.
3. PTSD Symptoms [ Time Frame: Baseline, 1, 6 months ]
   Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
4. Quality of Life-Physical and Mental [ Time Frame: Baseline, 1, 6 months ]
   PROMIS Global v 2.0, 0-50. Higher is higher qol.
5. Self-Efficacy Expectation [ Time Frame: Baseline, 1, 6 months ]
   Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
6. Outcome expectation, 0-90. Higher is higher OE. [ Time Frame: Baseline, 1, 6 months ]
   OE Scale
7. Salivary cortisol [ Time Frame: Baseline, 1, 6 months ]
   Cortisol in saliva, the range in humans varies. measured in pg/ml.
8. Feasibility [ Time Frame: 6 months ]
   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.
9. Acceptability [ Time Frame: 6 months ]
   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.
10. Safety [ Time Frame: 2 years ]
    Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Cynthia M Dougherty, ARNP, PhD; 206 221-7927; cindyd@uw.edu

Locations

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

East Carolina University

National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Cynthia M Dougherty, ARNP, PhD; University of Washington

More Information

• Responsible Party: Cynthia M. Dougherty, Adjunct Associate Professor: School of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT06037785
• Other Study ID Numbers: STUDY00007840; 1R21NR020967-01 ( U.S. NIH Grant/Contract )
• First Posted: September 14, 2023
• Last Update Posted: September 14, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Time Frame: 1 year after trial completion, available for up to 5 years after trial completion
• Access Criteria: Contact PI
• URL: https://nursing.uw.edu/person/cynthia-dougherty/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cynthia M. Dougherty, University of Washington:

implantable cardioverter defibrillator; ptsd; stress management

Additional relevant MeSH terms:

Fractures, Stress; Fractures, Bone; Wounds and Injuries