Clinical trial NCT03123224: The COACH Project: Combined Online Assistance for Caregiver Health
Official title: Combined Online Assistance for Caregiver Health (COACH): The Efficacy of a Combined Physical Activity and Coping Skills Training Intervention for Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumas, Brain
Alzheimer Disease
Dementia
Head Injury
Concussion, Brain
TBI
Keywords: Caregiver
Caregiving
TBI
dementia
Alzheimer's disease
physical exercise
physical activity
psychosocial
caregiver skills training
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-04-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. individuals aged 18 - 85
2. distress associated with being the primary caregiver of a person with TBI or dementia
3. 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
4. provide at least one hour of care (supervision or direct assistance) per week over the past three months
5. approval by Primary Care Provider to participate in physical exercise
6. be proficient in spoken and written English

Exclusion Criteria:

1. current or lifetime history of any psychiatric disorder with psychotic features
2. prominent suicidal or homicidal ideation
3. current alcohol or substance abuse
4. diagnosis of probable or possible dementia
5. a Short Portable Mental Status score of ≥ 8
6. participation in another caregiver intervention within the past year
7. lack of regular access to the internet
8. 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)
9. inability to participate in an exercise stress test
10. morbid obesity (BMI \> 39)
11. 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.

Primary outcomes:
measure: Caregiver Burden using Zarit Burden Inventory
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References: