The COACH Project: Combined Online Assistance for Caregiver Health (COACH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Dementia; Alzheimer Disease; Head Injury; TBI; Concussion, Brain; Traumas, Brain
• Intervention / Treatment: Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training; Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • VA Palo Alto Health Care System
      • Contact: Amerah Hashmi; Phone Number: 65992 650-493-5000
      • Principal Investigator: Jennifer K Fairchild, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; dementia; Alzheimer's disease; Caregiver; TBI; psychosocial; physical exercise; Caregiving; caregiver skills training
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Neurodegenerative Diseases; Trauma, Nervous System; Tauopathies; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Dementia; Brain Injuries, Traumatic; Alzheimer Disease; Craniocerebral Trauma; Brain Concussion
• Other Study ID Numbers: FAI0003AGG; W81XWH-15-1-0246 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO