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The goal of this study is to compare a patient only to a patient+partner intervention on recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator (ICD) implantation.
The goal of this randomized trial is to test a patient+partner intervention against the patient only intervention on recovery outcomes of patients and partners after ICD implantation. By interventing with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. Over a five year period we will test the effects of a 12 week patient+partner intervention against a patient only intervention in the first year subsequent to ICD implantation, using a 2 group (N=150/group) randomized clinical trial design. Relevant data will be collected on ICD patients and intimate partners at hospital discharge, 1, 3, 6, 12 months post-ICD implantation. The four major outcomes are: physical functioning, psychological adjustment, health care utilization, and relationship impact. The primary analysis of treatment effect is the change in outcome variables from baseline to 3 months for the patient and partner. Secondarily, exploring long term effects of the intervention, theoretical elements, and the intervention effects by ICD implant reason will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient only | Experimental | Patient with the ICD is involved in the intervention |
|
| patient and partner | Experimental | patient with the ICD and intimate partner are involved in the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient only | Behavioral | education, behavioral strategies, psychological interventions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functioning | symptoms, health related quality of life, steps/day | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| psychological adjustment | anxiety, depression, ICD acceptance | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia M Dougherty, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cynthia M. Dougherty | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34302228 | Derived | Liberato ACS, Thompson EA, Dougherty CM. Intervention mediating effects of self-efficacy on patient physical and psychological health following ICD implantation. J Behav Med. 2021 Dec;44(6):842-852. doi: 10.1007/s10865-021-00244-8. Epub 2021 Jul 23. | |
| 30340060 | Derived | Dougherty CM, Thompson EA, Kudenchuk PJ. Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator. Heart Rhythm. 2019 Mar;16(3):453-459. doi: 10.1016/j.hrthm.2018.10.011. Epub 2018 Oct 16. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| patient and partner intervention |
| Behavioral |
education, psychological support, behavioral strategies |
|
| 26940383 | Derived | Lau ET, Thompson EA, Burr RL, Dougherty CM. Safety and Efficacy of an Early Home-Based Walking Program After Receipt of an Initial Implantable Cardioverter-Defibrillator. Arch Phys Med Rehabil. 2016 Aug;97(8):1228-36. doi: 10.1016/j.apmr.2016.02.007. Epub 2016 Mar 3. |
| 23107992 | Derived | Dougherty CM, Thompson EA, Kudenchuk PJ. Development and testing of an intervention to improve outcomes for partners following receipt of an implantable cardioverter defibrillator in the patient. ANS Adv Nurs Sci. 2012 Oct-Dec;35(4):359-77. doi: 10.1097/ANS.0b013e318271d2e8. |