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

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ClinicalTrials.gov Identifier: NCT03123224
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
J. Kaci Fairchild, PhD, Palo Alto Veterans Institute for Research

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.

Condition or disease Intervention/treatment Phase
Traumas, Brain Alzheimer Disease Dementia Head Injury Concussion, Brain TBI Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Online Assistance for Caregiver Health (COACH): The Efficacy of a Combined Physical Activity and Coping Skills Training Intervention for Caregivers
Study Start Date : August 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


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.




Primary Outcome Measures :
  1. Caregiver Burden using Zarit Burden Inventory [ Time Frame: Six Months ]
    Zarit Burden Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123224


Contacts
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Contact: Jennifer Fairchild, PhD 650-493-5000 ext 63432
Contact: Marisol Hernandez 650-493-5000 ext 65992

Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Amerah Hashmi    650-493-5000 ext 65992      
Principal Investigator: Jennifer K Fairchild, PhD         
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
United States Department of Defense

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Responsible Party: J. Kaci Fairchild, PhD, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT03123224     History of Changes
Other Study ID Numbers: FAI0003AGG
W81XWH-15-1-0246 ( Other Grant/Funding Number: Department of Defense )
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by J. Kaci Fairchild, PhD, Palo Alto Veterans Institute for Research:
Caregiver
Caregiving
TBI
dementia
Alzheimer's disease
physical exercise
physical activity
psychosocial
caregiver skills training

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Craniocerebral Trauma
Brain Concussion
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Trauma, Nervous System
Wounds and Injuries
Brain Injuries
Head Injuries, Closed
Wounds, Nonpenetrating