The COACH Project: Combined Online Assistance for Caregiver Health

Palo Alto Veterans Institute for Research

Status: Unknown

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

Treatments: Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training; Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03123224

W81XWH-15-1-0246 (Other Grant/Funding Number)

FAI0003AGG

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Combined Aerobic and Resistance Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training

Balance and Flexibility

Active Comparator group

Description:

Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry.

Treatment:

Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training