Alzheimer's DiseaseTRACNCT00721383
Telephone Resources and Assistance for Caregivers (TRAC)
A study testing Enhancing Physical Activity Intervention and CSBI in people with Alzheimer's Disease, run by Rush University Medical Center at 2 sites in United States.
Trial summary
The purpose of this randomized clinical trial is to test a 12-month multi-component health promotion intervention with home-based family caregivers of persons with Alzheimer's Disease and other related dementias. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Enhancing Physical Activity Intervention and CSBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Feb 2013
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Care recipient:
- Diagnosis of probable AD or related dementia (using NINCDS/ADA criteria)
- Reside in the community
- Receive assistance from a primary caregiver
- Caregiver:
- Are a spouse or other close family member of the person with AD/dementia
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- Age ≥ 40 years
- English-speaking
- Live with the care recipient (or close as in 5-10 miles)
- Provide ≥ 10 hours of care per week
- Caregiver for at least 6 months
- Are physically inactive, defined as accumulating ≤ 60 minutes of regular PA on a weekly basis for the past 6 months
- Reporting some to moderate levels of strain
- Are cognitively intact
- Have no major debilitating health problems that would prevent intervention participation
- Must have a telephone
- Willing to increase levels of physical activity
- Agree to assignment of treatment condition
Who cannot join
- Care receiver:
- Other dementias such as stroke or Parkinson's
- Terminal illness with life expectancy of less than six months
- Bedfast or confined to a bed or chair at least 22 hours a day for at least 3 of the previous 7 days
- ≥ 3 acute or medical or psychiatric hospitalizations in last year
- Caregiver:
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- Are involved in another caregiver clinical trial
- Have a terminal illness with life expectancy of less than 6 months
- Receiving active treatment for cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Clinical Trial to Enhance Caregiver Physical Activity
The purpose of this randomized clinical trial is to test a 12-month multi-component health promotion intervention with home-based family caregivers of persons with Alzheimer's Disease and other related dementias. Specific aims are to: 1) Test the primary hypothesis: The Enhancing Physical Activity treatment intervention will be more effective in increasing caregiver lifestyle physical activity than the Standard Care Intervention; 2) Test secondary hypotheses: The Enhancing Physical Activity treatment intervention will be more effective than the Standard Care Intervention in improving the following caregiver secondary outcomes: mental health, physical health and physical function; and 3) Evaluate the process of implementing a lifestyle physical activity intervention with family caregivers. The Standard Care Intervention focuses on well-established care-related education and support needs. The Enhancing Physical Activity treatment intervention focuses on two areas: increasing lifestyle physical activity and addressing well-established care-related concerns that are likely to interfere with increasing physical activity. A total of 190 middle-age to older community-based primary caregivers of persons with Alzheimer's disease or other related dementias who report some to moderate strain with caregiving activities will be randomly assigned to either the Enhancing Physical Activity or Standard Care Intervention. Data will be collected at baseline, 3, 6, 9, 12 and 18 months and include self-report and direct observational methods. Data will be analyzed by using repeated measures models using the generalized estimating equation approach. Family caregivers are a stressed population who experience changes in their mental and physical health. However, effect sizes have been minimal for interventions designed to only affect caregiver mental health. No study known to us, has tested the added value of physical activity adoption in conjunction with more traditional caregiver support and skill building. Study findings will enable us to evaluate the behavioral , physical, and health-related quality of life effects achieved by the combined intervention; and will add knowledge about the most effective ways of intervening with family caregivers and other chronically stressed middle-age and older adult populations.
- Conditions
- Alzheimer's Disease
- Being tested
- Enhancing Physical Activity Intervention, CSBI
- Keywords
- caregiving, Alzheimer's disease, physical activity
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing Physical Activity InterventionBehavioural
Also called EPAI
Physical activity and caregiver skill-building
CSBIBehavioural
Caregiver skill-building
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Physical activity and caregiver skill-building Receives: Behavioral: Enhancing Physical Activity Intervention |
| Control | Active comparator | caregiver skill-building Receives: Behavioral: CSBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported physical activity
Measured: 18 months
Secondary outcomes (4)
caregiving burden
Measured: 18 months
caregiver positive well-being
Measured: 18 months
self-reported physical health
Measured: 18 months
physical function
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startMay 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Carol J Farran, DNSc, RN, FAAN, Rush University Medical Center
- Investigators
- Carol J Farran, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721383
- Sponsor's protocol ID
- 04092307
- Acronym
- TRAC
- Status last verified
- Dec 2014
- First submitted
- 22 Jul 2008
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Enhance Caregiver Physical Activity
- ClinicalTrials.gov ID
- NCT00721383
- Acronym / sponsor ID
- TRAC / 04092307
- Conditions
- Alzheimer's Disease
- Keywords
- caregiving, Alzheimer's disease, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- May 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Jul 2008 (estimated)
- 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.
The purpose of this randomized clinical trial is to test a 12-month multi-component health promotion intervention with home-based family caregivers of persons with Alzheimer's Disease and other related dementias. Specific aims are to: 1) Test the primary hypothesis: The Enhancing Physical Activity treatment intervention will be more effective in increasing caregiver lifestyle physical activity than the Standard Care Intervention; 2) Test secondary hypotheses: The Enhancing Physical Activity treatment intervention will be more effective than the Standard Care Intervention in improving the following caregiver secondary outcomes: mental health, physical health and physical function; and 3) Evaluate the process of implementing a lifestyle physical activity intervention with family caregivers. The Standard Care Intervention focuses on well-established care-related education and support needs. The Enhancing Physical Activity treatment intervention focuses on two areas: increasing lifestyle physical activity and addressing well-established care-related concerns that are likely to interfere with increasing physical activity. A total of 190 middle-age to older community-based primary caregivers of persons with Alzheimer's disease or other related dementias who report some to moderate strain with caregiving activities will be randomly assigned to either the Enhancing Physical Activity or Standard Care Intervention. Data will be collected at baseline, 3, 6, 9, 12 and 18 months and include self-report and direct observational methods. Data will be analyzed by using repeated measures models using the generalized estimating equation approach. Family caregivers are a stressed population who experience changes in their mental and physical health. However, effect sizes have been minimal for interventions designed to only affect caregiver mental health. No study known to us, has tested the added value of physical activity adoption in conjunction with more traditional caregiver support and skill building. Study findings will enable us to evaluate the behavioral , physical, and health-related quality of life effects achieved by the combined intervention; and will add knowledge about the most effective ways of intervening with family caregivers and other chronically stressed middle-age and older adult populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Enhancing Physical Activity InterventionPhysical activity and caregiver skill-building |
| Control | Active comparator | Behavioral: CSBIcaregiver skill-building |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of probable AD or related dementia (using NINCDS/ADA criteria)
- Reside in the community
- Receive assistance from a primary caregiver
- Are a spouse or other close family member of the person with AD/dementia
- Age ≥ 40 years
Key exclusion criteria (9 listed)
- Other dementias such as stroke or Parkinson's
- Terminal illness with life expectancy of less than six months
- Bedfast or confined to a bed or chair at least 22 hours a day for at least 3 of the previous 7 days
- ≥ 3 acute or medical or psychiatric hospitalizations in last year
- Are involved in another caregiver clinical trial
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 |
|---|---|---|
| Enhancing Physical Activity InterventionAlso: EPAIPhysical activity and caregiver skill-building | Behavioural | Treatment |
| CSBICaregiver skill-building | Behavioural | Control |
Primary outcome
self-reported physical activity
Time frame: 18 months
4 secondary outcomes
caregiving burden
Time frame: 18 months
caregiver positive well-being
Time frame: 18 months
self-reported physical health
Time frame: 18 months
physical function
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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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.
Carol J Farran, PhD principal investigator
Rush University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing Physical Activity Intervention and CSBI in people with Alzheimer's Disease, run by Rush University Medical Center at 2 sites 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 18 inclusion and 9 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: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported physical activity (time frame: 18 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 31 Dec 2014.