The COACH Project: Combined Online Assistance for Caregiver Health
Status unconfirmed · Not applicable
Conditions studied: Traumas, Brain, Alzheimer Disease, Dementia, Head Injury, Concussion, Brain, TBI
In brief
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.
Key facts
- Study ID
- NCT03123224
- Run by
- Palo Alto Veterans Institute for Research
- People needed
- 200
- Starts
- 2015-08-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2018-01-18
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- VA Palo Alto Health Care System — Palo Alto, California, United States (enrolling)
Full record on ClinicalTrials.gov
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