Heart Arrest, Implantable Defibrillator User, Physical Activity
Conditions
Brief summary
This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.
Detailed description
The goal of this study is to test the effectiveness and describe implementation of a home based exercise intervention for persons with an implantable cardioverter defibrillator (ICD). This study is based on the NIH stage model of behavioral interventions (stage III effectiveness) that aligns with the strategic mission of the NHLBI, to optimize clinical and implementation research to improve health and reduce disease (Obj #6). The study intervention is based on the protocol and monitoring components that were developed in prior RCTs and a pilot study conducted by our team. From these studies, we created a home based exercise program called Exercise-ICD (E-ICD) for testing in a broader range of ICD patients, that assists individuals to start and monitor exercise safely after an ICD. An randomized two group (E-ICD vs. usual care) pragmatic effectiveness mixed-methods study is proposed, to determine the effectiveness of the E-ICD intervention and describe implementation by cardiac rehabilitation (CR) clinical staff. Two hundred ten (N=210) patients in 3 local study sites (70/site) in the greater Seattle, WA area will participate. E-ICD is guided by the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) model. The E-ICD intervention consists of 12 weeks of home walking exercise using exercise prescriptions and protocols validated in our previous work. The primary effectiveness outcome is patient physical activity (steps/day) after the E-ICD intervention at 3 months. We will determine the number of patients who reach the public health walking goal of moderate level exercise of 150 minutes/week at the end of the study. Measures will be taken at baseline, after the intervention at 3 months, and at 6 and 12 months to determine maintenance. The specific aims are to: 1) Test the hypothesis that participants randomized to E-ICD vs. usual care (UC) will demonstrate increased physical activity (minutes walked/week) \[primary outcome\], health related quality of life, gait speed, mobility, exercise self-efficacy; and reduced ICD shock anxiety and depression at 3 months (E-ICD Effectiveness), 2) Assess longer term effects of E-ICD on participant and health care system Maintenance, captured by 1) participant retention, satisfaction, and adherence at 12 months (total minutes/week), and 2) clinician and institutional intent to sustain use of the E-ICD intervention after the study, and 3) Evaluate the reach, adoption, and implementation of E-ICD by CR clinical staff. Reach will be assessed by the diverse patient participation rate, representativeness, and reasons for non-interest. Adoption is the participation rate and representativeness of the settings and staff who participate, and factors related to adoption. Implementation will be assessed by delivery fidelity of E-ICD and workflow adaptations, implementation costs, and consistency of delivery across settings.
Interventions
BEHAVIORALE-ICD Intervention
Home walking 3 days/week x 12 weeks
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
home walking exercise
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ICD implantation for primary or secondary prevention of sudden cardiac arrest, -ability to read, speak and write English,- * access to a reliable phone for 6 months after study entry, * able to ambulate without assist devices for at least 5-10 minutes/day * greater than 18 years of age.
Exclusion criteria
* current diagnosis of serious mental disorder, * regular non-medical use of illicit drugs (opiates, cocaine, amphetamines, etc.), -unstable angina, myocardial infarction, ICD shock or heart surgery within previous 3 months * pregnancy * concurrent participation in an exercise program \> 5 days/week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily activity | Baseline, 3, 6, and 12 months | average steps/day measured on Step Watch activity monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Health | Baseline, 3, 6, and 12 months | PROMIS Global v1.2 measures 5 domains of global health and quality of life, including physical, mental, and social health. Two factors physical health (GPH) and mental health (GMH) are derived. |
| Mobility | Baseline, 3, 6, and 12 months | PROMIS Mobility V2.1 measures general mobility of lower extremities in adults, relating to overall physical functioning |
| Self-Efficacy for Walking | Baseline, 3, 6, and 12 months | Self-Efficacy for Exercise Scale (9-items, α=0.92) assesses self-efficacy expectations related to one's ability to walk in the face of barriers to exercise \[22\], was used in the pilot and found to be sensitive to change with the intervention. |
| ICD shock anxiety | Baseline, 3, 6, and 12 months | Florida Shock Anxiety Scale (FSAS), assesses anxiety about receiving an ICD shock \[23\], is sensitive to change across time. |
| Depression | Baseline, 3, 6, and 12 months | Patient Health Questionnaire-9 (PHQ-9) (9 items, α=0.83), measures depressive symptoms, as well as suicidality. |
Countries
United States
Contacts
CONTACTCynthia M Dougherty, ARNP, PhD
PRINCIPAL_INVESTIGATORCynthia M Dougherty, ARNP, PhD
University of Washington
Outcome results
None listed