Self-Management Interventions After an ICD Shock
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ClinicalTrials.gov Identifier: NCT06037785 |
Recruitment Status :
Not yet recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: SPSM intervention
Heart rate self monitoring Online shock management modules
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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
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- ICD Shock anxiety [ Time Frame: Baseline, 1, 6 months ]Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.
- 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.
- Depression [ Time Frame: Baseline, 1, 6 months ]PHQ-9, 0-27. Higher is higher depression.
- PTSD Symptoms [ Time Frame: Baseline, 1, 6 months ]Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
- Quality of Life-Physical and Mental [ Time Frame: Baseline, 1, 6 months ]PROMIS Global v 2.0, 0-50. Higher is higher qol.
- Self-Efficacy Expectation [ Time Frame: Baseline, 1, 6 months ]Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
- Outcome expectation, 0-90. Higher is higher OE. [ Time Frame: Baseline, 1, 6 months ]OE Scale
- Salivary cortisol [ Time Frame: Baseline, 1, 6 months ]Cortisol in saliva, the range in humans varies. measured in pg/ml.
- 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.
- 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.
- Safety [ Time Frame: 2 years ]Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no.
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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06037785
Contact: Cynthia M Dougherty, ARNP, PhD | 206 221-7927 | cindyd@uw.edu |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Cynthia M Dougherty, ARNP, PhD | University of Washington |
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 Key Record Dates |
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 |
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