E-ICD: Implementing Exercise After an (ICD)

Sponsor

University of Washington (Other)

Overall Status

Unknown status

CT.gov ID

NCT03544489

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is the first feasibility test of a highly portable home-based exercise intervention after an ICD, using technology monitoring (rather than self-report) of intervention progress and outcomes. Evidence for intervention effectiveness will inform algorithms for initiating exercise post-ICD more broadly in clinical practice. This study aligns directly with recent scientific statements that recommend testing behavioral interventions for ICD patients that are based on participant engagement, use cognitive behavioral approaches, and are readily available when most needed.

Condition or Disease	Intervention/Treatment	Phase
Heart Arrest Implantable Defibrillator User Physical Activity	Behavioral: E-ICD Intervention	Phase 2

Detailed Description

The goal of this study is to test an exercise intervention that we developed in previous RCTS for feasibility in routine clinical practice. Based on results from our two completed randomized trials of exercise after an ICD, the investigators created a home based exercise program called (E-ICD) for use in routine practice that assists individuals to start and monitor exercise safely after an ICD. The study uses a randomized, two group parallel mixed-methods intervention trial, to determine the feasibility of the home-based E-ICD exercise program in routine clinical care. Ninety patients in 3 study sites (30/site) will participate in this 2 year study. The study sites are in the greater Seattle, WA area. This intervention study is guided by the Reach-Efficacy-Adoption-Implementation-Maintenance (RE-AIM) model. The E-ICD intervention consists of 12 weeks of home walking exercise after an ICD using the E-ICD program, with an exercise prescription and protocols validated in our previous work. The primary outcome of the study is total physical activity (steps/day) at 3 months. Measures will be taken at baseline, after the intervention at 3 months, and at 6 months. The specific aims of the study are to: 1) determine the reach, adoption and implementation of E-ICD into the clinical setting, 2) compare intervention efficacy for patient total daily activity (primary outcome) for E-ICD vs. usual care from baseline to intervention completion at 3 months, and 3) describe exercise maintenance for patient outcomes in E-ICD vs. usual care at 6 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

home walking exercisehome walking exercise

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Translation of Exercise Interventions Into Practice After an ICD

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E-ICD Intervention E-ICD Intervention over 3 months, consists of home walking to achieve the goal of 30 minutes on all or most of the days at moderate level intensity. E-ICD elements are: 1) exercise instructional DVD and manual, 2) exercise monitoring tools (Polar HR monitor, Digi-walker, Borg scale, and exercise logs), and 3) telephone coaching by clinic RNs. Each participant receives an exercise prescription based on the ICD information using HR cut-offs, a minimum of 4 walking sessions/week will be prescribed. Exercise maintenance: At the 3 month conclusion of the E-ICD intervention, each patient will receive an exercise prescription based on the level they were able to achieve, with guidelines about increasing exercise to reach the target of 30 minutes/walking on all or most days over the ensuing 3 months. Participants will record walking sessions each week in the exercise logs that will be collected again at 6 months.	Behavioral: E-ICD Intervention Home walking 3 days/week x 12 weeks
No Intervention: Usual Care Usual Care will receive treatment "as usual" from their health care clinicians with outcomes measured at baseline, 3 and 6 months. Participants will not be discouraged from physical activity, but will be asked not to change their current level of activity for 6 months while in the study. Usual care involves ICD interrogation and follow-up every 3 months, measured either in-person or with home telephonic transmissions. Because participants in usual care may choose to participate in another exercise program, we will monitor those who participate in exercise programs and use the StepWatch monitor to quantify the amount and timing of physical activity. To control for group differences in attention, investigators will telephone usual care participants requesting information about health care utilization twice during the study at 3 and 6 months.

Arm

Intervention/Treatment

Experimental: E-ICD Intervention

E-ICD Intervention over 3 months, consists of home walking to achieve the goal of 30 minutes on all or most of the days at moderate level intensity. E-ICD elements are: 1) exercise instructional DVD and manual, 2) exercise monitoring tools (Polar HR monitor, Digi-walker, Borg scale, and exercise logs), and 3) telephone coaching by clinic RNs. Each participant receives an exercise prescription based on the ICD information using HR cut-offs, a minimum of 4 walking sessions/week will be prescribed. Exercise maintenance: At the 3 month conclusion of the E-ICD intervention, each patient will receive an exercise prescription based on the level they were able to achieve, with guidelines about increasing exercise to reach the target of 30 minutes/walking on all or most days over the ensuing 3 months. Participants will record walking sessions each week in the exercise logs that will be collected again at 6 months.

Behavioral: E-ICD Intervention

Home walking 3 days/week x 12 weeks

No Intervention: Usual Care

Usual Care will receive treatment "as usual" from their health care clinicians with outcomes measured at baseline, 3 and 6 months. Participants will not be discouraged from physical activity, but will be asked not to change their current level of activity for 6 months while in the study. Usual care involves ICD interrogation and follow-up every 3 months, measured either in-person or with home telephonic transmissions. Because participants in usual care may choose to participate in another exercise program, we will monitor those who participate in exercise programs and use the StepWatch monitor to quantify the amount and timing of physical activity. To control for group differences in attention, investigators will telephone usual care participants requesting information about health care utilization twice during the study at 3 and 6 months.

Outcome Measures

Primary Outcome Measures

Daily activity [average of steps/day over 5 days after 12 weeks]
average steps/day measured on Step Watch activity monitor

Secondary Outcome Measures

General Health [after 12 weeks]
Short Form Health Survey (SF-36) [Physical Composite Score (PCS)]. Scores range from 0-100 with higher scores representing higher functioning. The PCS score is created using weighted averages from the 8 subscales of the SF-36.
General Health [after 12 weeks]
Short Form Health Survey (SF-36) [Mental Composite Score (MCS)]. Scores range from 0-100 with higher scores representing higher functioning. The MCS score is created using weighted averages from the 8 subscales of the SF-36.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

University of Washington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cynthia M. Dougherty, Professor, University of Washington

ClinicalTrials.gov Identifier:

NCT03544489

Other Study ID Numbers:

STUDY00002057

First Posted:

Jun 1, 2018

Last Update Posted:

Jun 13, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Arrest

Study Results

No Results Posted as of Jun 13, 2018