Alzheimer's DiseaseNCT00182897
PACT: Providers and Alzheimer's Caregivers Together
A study testing Skills Building for Caregiver Health and Care-recipient in people with Alzheimer's Disease and Dementia, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The primary goal of the study is documentation of effectiveness of a home-based intervention to reduce caregiver burden related to dementia caregiving, improve caregiver health status, and reduce caregiver and care recipient resource utilization. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Skills Building for Caregiver Health and Care-recipient
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Nov 2005
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Care Recipient - Inclusion Criteria (must have all)
- Documented diagnosis of dementia or Mini-Mental State Exam score <23
- Functional impairment: presence of two IADL (Instrumental Activities of Daily Living) impairment (transportation, shopping) or one Activities of Daily Living (ADL) impairment (bathing, toileting)
- Caregiver - Inclusion Criteria (must have all)
- At least 21 years old
- A family member of the care recipient
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- Must have a telephone
- Must plan to remain in the area for the duration of the intervention and follow-up
- Must have been a caregiver for more than 6 months
- Must provide at least 4 hours of supervision or direct assistance per day for the care recipient
Who cannot join
- Care Recipient
- Any terminal illness with life expectancy of less than 6 months
- Active treatment (chemotherapy or radiation therapy) for cancer
- More than three acute medical hospitalizations in the past year (other than psychiatric or Alzheimer's Disease related admissions)
- Schizophrenia
- Dementia secondary to head trauma
Show all 14Show fewer
- Blindness or deafness if either disability prohibits them from data collection or participation in the interventions
- Caregiver
- Any terminal illness with life expectancy of less than 6 months
- Active treatment (chemotherapy or radiation therapy) for cancer
- More than three acute medical hospitalizations in the past year
- Imminent placement of care recipient into a nursing home (within 6 months)
- Involvement in another clinical trial for caregivers, including REACH
- Miscellaneous barriers such as transportation, commitment, hesitancy, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
Official title: Providers and Alzheimer's Caregivers Together
The primary goal of the study is documentation of effectiveness of a home-based intervention to reduce caregiver burden related to dementia caregiving, improve caregiver health status, and reduce caregiver and care recipient resource utilization.
Read the detailed description
This study focuses on an underserved, understudied population: African American and White homebound persons with dementia and their caregivers (CGs). Severe dementia, frailty, multiple disabling co-morbid diseases, lack of transportation, inability to afford or obtain a sitter for the care recipient (CR), and lack of time in a CG's burdened daily schedule may prevent care dyads (caregivers and their family member with dementia) from receiving services in primary care settings and from participating in clinical studies. Homebound issues may be particularly important for African American CGs, yet the minority CG literature has not addressed relevant issues for homebound dyads. Nor are the chronic needs of homebound dementia care dyads adequately attended by the current home health care system, which now focuses on skilled nursing care. This study has been designed to address these research deficits. The study will examine the benefit (through improving depression, anxiety, and health perception) and the cost-effectiveness of home-based dementia caregiving interventions, with attention to both the informal care provided by the CG and the use of formal care services.
Care dyads will be randomized to either Usual Care or Enhanced Care. Both Usual Care and Enhanced Care caregivers will receive usual home health care delivered by home health nurses on the schedule determined by the patient's needs and set by the home care agency. For the Enhanced Care caregivers, to ensure protocol adherence, using the same schedule as the home health visits, trained interventionists from the research staff will deliver the intervention. The interventionists will teach dementia family caregivers to cope with difficult care recipient behaviors and challenges to caregiving and will teach caregivers how to cope with their own responses to caregiving. Following established protocols and using fifth grade level pamphlets and educational material, the interventionists will tailor the intervention sessions to meet the individual needs of each care dyad in their own home environment. Enhanced Care sessions will not exceed 60 minutes. Research specialists will perform data collection visits in the care dyads' homes at baseline, within 2 weeks of home care ending and six months.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Skills Building for Caregiver Health and Care-recipient
- Keywords
- caregiver, home health care, coping
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills Building for Caregiver Health and Care-recipientBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
General well-being, measured with the revised Rand General Well-Being Scale
caregiver's level of distress with care recipient behaviors, measured with the Revised Memory and Behavior Problems Checklist at Baseline, within 2 weeks of home care ending and six months.
Secondary outcomes (1)
Determine the cost-effectiveness of home-based intervention; data will be collected at Baseline, within 2 weeks of home care ending and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2000
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Linda Nichols, PhD, Principal investigator, Program Director, Interprofessional Team Training & Development, Veterans Affairs Medical Center; Associate Professor, Preventive Medicine and Medicine, University of Tennessee Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182897
- Sponsor's protocol ID
- IA0081
- Other IDs
- 5R01AG016328
- Status last verified
- Nov 2006
- First submitted
- 12 Sep 2005
- Last updated
- 14 Nov 2006
- Results posted
- No
Publications
Burns R, Nichols LO, Martindale-Adams J, Graney MJ, Lummus A. Primary care interventions for dementia caregivers: 2-year outcomes from the REACH study. Gerontologist. 2003 Aug;43(4):547-55. doi: 10.1093/geront/43.4.547.
PubMed 12937333Connell CM, Gibson GD. Racial, ethnic, and cultural differences in dementia caregiving: review and analysis. Gerontologist. 1997 Jun;37(3):355-64. doi: 10.1093/geront/37.3.355.
PubMed 9203759Haley WE, Roth DL, Coleton MI, Ford GR, West CA, Collins RP, Isobe TL. Appraisal, coping, and social support as mediators of well-being in black and white family caregivers of patients with Alzheimer's disease. J Consult Clin Psychol. 1996 Feb;64(1):121-9. doi: 10.1037//0022-006x.64.1.121.
PubMed 8907091Hall GR, Buckwalter KC, Stolley JM, Gerdner LA, Garand L, Ridgeway S, Crump S. Standardized care plan. Managing Alzheimer's patients at home. J Gerontol Nurs. 1995 Jan;21(1):37-47. doi: 10.3928/0098-9134-19950101-08.
PubMed 7852717
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providers and Alzheimer's Caregivers Together
- ClinicalTrials.gov ID
- NCT00182897
- Acronym / sponsor ID
- IA0081
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- caregiver, home health care, coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2000
- Study completion
- Nov 2005
- First posted
- 16 Sep 2005 (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 primary goal of the study is documentation of effectiveness of a home-based intervention to reduce caregiver burden related to dementia caregiving, improve caregiver health status, and reduce caregiver and care recipient resource utilization.
Detailed description
This study focuses on an underserved, understudied population: African American and White homebound persons with dementia and their caregivers (CGs). Severe dementia, frailty, multiple disabling co-morbid diseases, lack of transportation, inability to afford or obtain a sitter for the care recipient (CR), and lack of time in a CG's burdened daily schedule may prevent care dyads (caregivers and their family member with dementia) from receiving services in primary care settings and from participating in clinical studies. Homebound issues may be particularly important for African American CGs, yet the minority CG literature has not addressed relevant issues for homebound dyads. Nor are the chronic needs of homebound dementia care dyads adequately attended by the current home health care system, which now focuses on skilled nursing care. This study has been designed to address these research deficits. The study will examine the benefit (through improving depression, anxiety, and health perception) and the cost-effectiveness of home-based dementia caregiving interventions, with attention to both the informal care provided by the CG and the use of formal care services.
Care dyads will be randomized to either Usual Care or Enhanced Care. Both Usual Care and Enhanced Care caregivers will receive usual home health care delivered by home health nurses on the schedule determined by the patient's needs and set by the home care agency. For the Enhanced Care caregivers, to ensure protocol adherence, using the same schedule as the home health visits, trained interventionists from the research staff will deliver the intervention. The interventionists will teach dementia family caregivers to cope with difficult care recipient behaviors and challenges to caregiving and will teach caregivers how to cope with their own responses to caregiving. Following established protocols and using fifth grade level pamphlets and educational material, the interventionists will tailor the intervention sessions to meet the individual needs of each care dyad in their own home environment. Enhanced Care sessions will not exceed 60 minutes. Research specialists will perform data collection visits in the care dyads' homes at baseline, within 2 weeks of home care ending and six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Care Recipient - Inclusion Criteria (must have all)
- Documented diagnosis of dementia or Mini-Mental State Exam score <23
- Functional impairment: presence of two IADL (Instrumental Activities of Daily Living) impairment (transportation, shopping) or one Activities of Daily Living (ADL) impairment (bathing, toileting)
- Caregiver - Inclusion Criteria (must have all)
- At least 21 years old
Key exclusion criteria (14 listed)
- Care Recipient
- Any terminal illness with life expectancy of less than 6 months
- Active treatment (chemotherapy or radiation therapy) for cancer
- More than three acute medical hospitalizations in the past year (other than psychiatric or Alzheimer's Disease related admissions)
- Schizophrenia
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 |
|---|---|---|
| Skills Building for Caregiver Health and Care-recipient | Behavioural | – |
Primary outcome
General well-being, measured with the revised Rand General Well-Being Scale
caregiver's level of distress with care recipient behaviors, measured with the Revised Memory and Behavior Problems Checklist at Baseline, within 2 weeks of home care ending and six months.
1 secondary outcome
Determine the cost-effectiveness of home-based intervention; data will be collected at Baseline, within 2 weeks of home care ending and six 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 14 Nov 2006.
- Background: PubMed 12937333Burns R, Nichols LO, Martindale-Adams J, Graney MJ, Lummus A. Primary care interventions for dementia caregivers: 2-year outcomes from the REACH study. Gerontologist. 2003 Aug;43(4):547-55. doi: 10.1093/geront/43.4.547.
- Background: PubMed 9203759Connell CM, Gibson GD. Racial, ethnic, and cultural differences in dementia caregiving: review and analysis. Gerontologist. 1997 Jun;37(3):355-64. doi: 10.1093/geront/37.3.355.
- Background: PubMed 8907091Haley WE, Roth DL, Coleton MI, Ford GR, West CA, Collins RP, Isobe TL. Appraisal, coping, and social support as mediators of well-being in black and white family caregivers of patients with Alzheimer's disease. J Consult Clin Psychol. 1996 Feb;64(1):121-9. doi: 10.1037//0022-006x.64.1.121.
- Background: PubMed 7852717Hall GR, Buckwalter KC, Stolley JM, Gerdner LA, Garand L, Ridgeway S, Crump S. Standardized care plan. Managing Alzheimer's patients at home. J Gerontol Nurs. 1995 Jan;21(1):37-47. doi: 10.3928/0098-9134-19950101-08.
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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.
Linda Nichols, PhD principal investigator
Program Director, Interprofessional Team Training & Development, Veterans Affairs Medical Center; Associate Professor, Preventive Medicine and Medicine, University of Tennessee Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills Building for Caregiver Health and Care-recipient in people with Alzheimer's Disease and Dementia, run by National Institute on Aging (NIA) 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 10 inclusion and 14 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 14 Nov 2006. 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?
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?
General well-being, measured with the revised Rand General Well-Being Scale. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182897, which also lists 4 linked publications.
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 14 Nov 2006.