The COACH Project: Combined Online Assistance for Caregiver Health

NCT ID: NCT03123224

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined Aerobic and Resistance Exercise

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.

Group Type: EXPERIMENTAL

Combined Aerobic and Resistance Exercise + Caregiver Skills Training

Intervention Type: BEHAVIORAL

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.

Balance and Flexibility

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

Group Type: ACTIVE_COMPARATOR

Stretching Balance and Flexibility + Caregiver Skills Training

Intervention Type: BEHAVIORAL

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.

Interventions

Combined Aerobic and Resistance Exercise + Caregiver Skills Training

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.

Intervention Type: BEHAVIORAL

Stretching Balance and Flexibility + Caregiver Skills Training

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

J. Kaci Fairchild, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Fairchild, PhD

Role: CONTACT

650-493-5000 ext. 63432

Marisol Hernandez

Role: CONTACT

650-493-5000 ext. 65992

Facility Contacts

Amerah Hashmi

Role: primary

650-493-5000 ext. 65992

Other Identifiers

W81XWH-15-1-0246

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FAI0003AGG

Identifier Type: -

Identifier Source: org_study_id