The COACH Project: Combined Online Assistance for Caregiver Health

Alzheimer Disease Clinical Trial

— COACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03123224
• Other study ID #: FAI0003AGG
• Secondary ID: W81XWH-15-1-0246
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2017
• Last updated: January 16, 2018
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Palo Alto Veterans Institute for Research
• Contact: Jennifer Fairchild, PhD
• Phone: 650-493-5000
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Concussion
• Brain Injuries, Traumatic
• Concussion, Brain
• Craniocerebral Trauma
• Dementia
• Head Injury
• TBI
• Traumas, Brain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Burden using Zarit Burden Inventory	Zarit Burden Inventory	Six Months