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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

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:

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.

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

NCT ID

NCT03123224

First Posted

April 3, 2017

Last Updated

January 16, 2018

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

United States Department of Defense

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

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

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

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

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The COACH Project: Combined Online Assistance for Caregiver Health

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