Combined Online Assistance for Caregiver Health (COACH): The Efficacy of a Combined Physical Activity and Coping Skills Training Intervention for Caregivers

Palo Alto Veterans Institute for Research1 site in 1 country200 target enrollmentAugust 2015

ConditionsTraumas, Brain Alzheimer Disease Dementia Head Injury Concussion, Brain TBI

Overview

Phase: N/A
Intervention: Not specified
Conditions: Traumas, Brain
Sponsor: Palo Alto Veterans Institute for Research
Enrollment: 200
Locations: 1
Primary Endpoint: Caregiver Burden using Zarit Burden Inventory
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

July 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Palo Alto Veterans Institute for Research

Responsible Party

Principal Investigator

J. Kaci Fairchild, PhD

Principal Investigator

Palo Alto Veterans Institute for Research

Eligibility Criteria

Inclusion Criteria

•individuals aged 18 - 85
•distress associated with being the primary caregiver of a person with TBI or dementia
•endorsement of at least two of the following items: felt overwhelmed, felt like needed to cry, angry or frustrated, distant or cut of from family or friends, moderate to high levels of stress, felt their health had declined
•provide at least one hour of care (supervision or direct assistance) per week over the past three months
•approval by Primary Care Provider to participate in physical exercise
•be proficient in spoken and written English

Exclusion Criteria

•current or lifetime history of any psychiatric disorder with psychotic features
•prominent suicidal or homicidal ideation
•current alcohol or substance abuse
•diagnosis of probable or possible dementia
•a Short Portable Mental Status score of ≥ 8
•participation in another caregiver intervention within the past year
•lack of regular access to the internet
•planned transfer of care recipient to another caregiver or nursing home within 12 months; 8) current severe cardiac disease (e.g., uncontrolled atrial fibrillation, defined as mean 24 hour heart rate \>85 beats/min, or 24 hour maximal ventricular rate \>150 beats/min; uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia \>3 beats in succession, or 24 hour PVC count \>20%; active pericarditis or myocarditis; Class III/IV heart failure and / or ejection fraction \< 20%; thrombophlebitis; pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen; embolism within past 6 months)
•inability to participate in an exercise stress test
•morbid obesity (BMI \> 39)