Traumas, BrainCOACHNCT03123224
The COACH Project: Combined Online Assistance for Caregiver Health
A study testing Combined Aerobic and Resistance Exercise + Caregiver Skills Training and Stretching Balance and Flexibility + Caregiver Skills Training in people with Traumas, Brain and Alzheimer Disease, run by Palo Alto Veterans Institute for Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumas, Brain, Alzheimer Disease, Dementia
- What is being tested?
- Combined Aerobic and Resistance Exercise + Caregiver Skills Training and Stretching Balance and Flexibility + Caregiver Skills Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Jennifer Fairchild, PhD contact
Marisol Hernandez contact
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Amerah Hashmi, 650-493-5000 ext. 65992
Jennifer K Fairchild, PhD
About this study
Official title: 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.
- Conditions
- Traumas, Brain, Alzheimer Disease, Dementia, Head Injury, Concussion, Brain, TBI
- Being tested
- Combined Aerobic and Resistance Exercise + Caregiver Skills Training, Stretching Balance and Flexibility + Caregiver Skills Training
- Keywords
- Caregiver, Caregiving, TBI, dementia, Alzheimer's disease, physical exercise, physical activity, psychosocial, caregiver skills training
- Medical subject headings
- Brain Injuries, Traumatic, Alzheimer Disease, Dementia, Craniocerebral Trauma, Brain Concussion, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Aerobic and Resistance Exercise + Caregiver Skills TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Aerobic and Resistance Exercise | Experimental | 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. Receives: Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training |
| Balance and Flexibility | Active comparator | Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry. Receives: Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden using Zarit Burden Inventory
Zarit Burden Inventory
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startAug 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumas, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, J. Kaci Fairchild, PhD, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123224
- Sponsor's protocol ID
- FAI0003AGG
- Other IDs
- W81XWH-15-1-0246
- Acronym
- COACH
- Status last verified
- Jan 2018
- First submitted
- 3 Apr 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Online Assistance for Caregiver Health (COACH): The Efficacy of a Combined Physical Activity and Coping Skills Training Intervention for Caregivers
- ClinicalTrials.gov ID
- NCT03123224
- Acronym / sponsor ID
- COACH / FAI0003AGG
- Conditions
- Traumas, Brain, Alzheimer Disease, Dementia, Head Injury, Concussion, Brain, TBI
- Keywords
- Caregiver, Caregiving, TBI, dementia, Alzheimer's disease, physical exercise, physical activity, psychosocial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Aug 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Aerobic and Resistance Exercise | Experimental | Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills TrainingParticipants 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. |
| Balance and Flexibility | Active comparator | Behavioral: Stretching Balance and Flexibility + Caregiver Skills TrainingParticipants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Aerobic and Resistance Exercise + Caregiver Skills TrainingThe 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. | Behavioural | Combined Aerobic and Resistance Exercise |
| Stretching Balance and Flexibility + Caregiver Skills TrainingThe 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. | Behavioural | Balance and Flexibility |
Primary outcome
Caregiver Burden using Zarit Burden Inventory
Time frame: Six Months
Zarit Burden Inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Fairchild, PhD contact
Marisol Hernandez contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Aerobic and Resistance Exercise + Caregiver Skills Training and Stretching Balance and Flexibility + Caregiver Skills Training in people with Traumas, Brain and Alzheimer Disease, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Fairchild, PhD (650-493-5000 ext. 63432), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden using Zarit Burden Inventory (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.