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

Primary Purpose

Traumas, Brain, Alzheimer Disease, Dementia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Aerobic and Resistance Exercise + Caregiver Skills Training
Stretching Balance and Flexibility + Caregiver Skills Training
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumas, Brain focused on measuring Caregiver, Caregiving, TBI, dementia, Alzheimer's disease, physical exercise, physical activity, psychosocial, caregiver skills training

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • VA Palo Alto Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined Aerobic and Resistance Exercise

Balance and Flexibility

Arm 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.

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

Outcomes

Primary Outcome Measures

Caregiver Burden using Zarit Burden Inventory
Zarit Burden Inventory

Secondary Outcome Measures

Full Information

First Posted
April 3, 2017
Last Updated
January 16, 2018
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03123224
Brief Title
The COACH Project: Combined Online Assistance for Caregiver Health
Acronym
COACH
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined Aerobic and Resistance Exercise
Arm Type
Experimental
Arm 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.
Arm Title
Balance and Flexibility
Arm Type
Active Comparator
Arm Description
Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry.
Intervention Type
Behavioral
Intervention Name(s)
Combined Aerobic and Resistance Exercise + Caregiver Skills Training
Intervention Description
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
Intervention Name(s)
Stretching Balance and Flexibility + Caregiver Skills Training
Intervention Description
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 Measure Information:
Title
Caregiver Burden using Zarit Burden Inventory
Description
Zarit Burden Inventory
Time Frame
Six Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: individuals aged 18 - 85 distress associated with being the primary caregiver of a person with TBI or dementia 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 provide at least one hour of care (supervision or direct assistance) per week over the past three months approval by Primary Care Provider to participate in physical exercise be proficient in spoken and written English Exclusion Criteria: current or lifetime history of any psychiatric disorder with psychotic features prominent suicidal or homicidal ideation current alcohol or substance abuse diagnosis of probable or possible dementia a Short Portable Mental Status score of ≥ 8 participation in another caregiver intervention within the past year lack of regular access to the internet 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) inability to participate in an exercise stress test morbid obesity (BMI > 39) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Fairchild, PhD
Phone
650-493-5000
Ext
63432
First Name & Middle Initial & Last Name or Official Title & Degree
Marisol Hernandez
Phone
650-493-5000
Ext
65992
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amerah Hashmi
Phone
650-493-5000
Ext
65992
First Name & Middle Initial & Last Name & Degree
Jennifer K Fairchild, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The COACH Project: Combined Online Assistance for Caregiver Health

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