The COACH Project: Combined Online Assistance for Caregiver Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Traumas, Brain, Alzheimer Disease, Dementia, Head Injury, Concussion, Brain, TBI

Intervention / Treatment
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* Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training
* Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training


Participation Criteria
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Eligibility Criteria
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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) inability to read, verbalize understanding and voluntarily sign the Informed Consent. Caregivers meeting any of these exclusion criteria will be excluded from all aspects of this project.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Aerobic and Resistance Exercise<br>Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry. Exercises will focus on increasing the heart rate to a point at which participants will breathe more heavily and may sweat. | Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training<br>* The combined moderate to high intensity combined aerobic and resistance exercise training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.<br>|
| Active Comparator: Balance and Flexibility<br>Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry. | Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training<br>* The stretching, balance and flexibility training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Burden using Zarit Burden Inventory | Zarit Burden Inventory | Six Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Caregiving, TBI, dementia, Alzheimer's disease, physical exercise, physical activity, psychosocial, caregiver skills training