Alzheimer's DiseaseNCT00182988
Alzheimer's Caregiver Communication Study
An observational study of Alzheimer's Disease, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The point of this research is to improve the communicative relationship between the caregiver and care receiver. It is input from the caregiver on these communicative behaviors that will inform the process of understanding how to reduce the caregiver burden that comes from this communicative relationship. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2007
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Couples including spouse or family member who spend at least 2-3 hours per day together
- Both must be cognitively intact
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 22057
About this study
Official title: Alzheimer's Caregiver Ratings of Communication & Coping Behavior
The point of this research is to improve the communicative relationship between the caregiver and care receiver. It is input from the caregiver on these communicative behaviors that will inform the process of understanding how to reduce the caregiver burden that comes from this communicative relationship.
Read the detailed description
This research study is developing a new checklist to measure communicative coping behaviors of persons with Alzheimer's Disease in the home environment. The Communicative Coping Behavior Checklist (CCBC) is an observation checklist to be completed by the caregiver or knowledgeable informant. The current version includes 23 behaviors to be rated for frequency and effectiveness. The behaviors that will be observed cover management of memory loss within three broad categories: humor, explanations, and general coping behaviors.
Two kinds of couples will participate in this study. One includes a person with Alzheimer's Disease and their caregiver. The second includes a cognitively intact participant and study partner, both over the age of 60, to serve as controls.
Study Visit 1 (3 hours long) During the first visit, the person with Alzheimer's Disease/control participant can expect to be asked questions about their memory, thinking and concentration, demographics, quality of life, and mood. The caregiver/study partner will be asked about their quality of life, mood, and daily activities.
At the end of the visit the caregiver/study partner will be given a copy of the CCBC and asked to take it home. S/he will be instructed to rate the person with Alzheimer's Disease/ control participant's communicative coping behavior over the course of the next two weeks. At the end of that time, a research assistant will call the caregiver/study partner and administer the CCBC over the telephone.
Study Visit 2 (3 hours long) The second visit will occur in the clinic approximately 12 months from the date of the first visit. As with the first study visit, again both the person with Alzheimer's Disease/control participant and the caregiver/study partner will answer questions about their memory, quality of life, mood, and daily activities. Once again, the caregiver/study partner will be given a copy of the CCBC and asked to take it home and complete.
Both visits will take about three hours for the caregiver/study partner and about two hours for the person with dementia or control subject.
- Conditions
- Alzheimer's Disease
- Keywords
- communication behavior, coping, functional ability, quality of life, caregiving
- Medical subject headings
- Alzheimer Disease
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 2004
- Study completionDec 2007
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.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Pamela Saunders, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182988
- Sponsor's protocol ID
- IA0082
- Other IDs
- 1R03AG022627
- Status last verified
- Nov 2009
- First submitted
- 13 Sep 2005
- Last updated
- 25 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Caregiver Ratings of Communication & Coping Behavior
- ClinicalTrials.gov ID
- NCT00182988
- Acronym / sponsor ID
- IA0082
- Conditions
- Alzheimer's Disease
- Keywords
- communication behavior, coping, functional ability, quality of life, caregiving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Oct 2004
- Study completion
- Dec 2007 (actual)
- 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 point of this research is to improve the communicative relationship between the caregiver and care receiver. It is input from the caregiver on these communicative behaviors that will inform the process of understanding how to reduce the caregiver burden that comes from this communicative relationship.
Detailed description
This research study is developing a new checklist to measure communicative coping behaviors of persons with Alzheimer's Disease in the home environment. The Communicative Coping Behavior Checklist (CCBC) is an observation checklist to be completed by the caregiver or knowledgeable informant. The current version includes 23 behaviors to be rated for frequency and effectiveness. The behaviors that will be observed cover management of memory loss within three broad categories: humor, explanations, and general coping behaviors.
Two kinds of couples will participate in this study. One includes a person with Alzheimer's Disease and their caregiver. The second includes a cognitively intact participant and study partner, both over the age of 60, to serve as controls.
Study Visit 1 (3 hours long) During the first visit, the person with Alzheimer's Disease/control participant can expect to be asked questions about their memory, thinking and concentration, demographics, quality of life, and mood. The caregiver/study partner will be asked about their quality of life, mood, and daily activities.
At the end of the visit the caregiver/study partner will be given a copy of the CCBC and asked to take it home. S/he will be instructed to rate the person with Alzheimer's Disease/ control participant's communicative coping behavior over the course of the next two weeks. At the end of that time, a research assistant will call the caregiver/study partner and administer the CCBC over the telephone.
Study Visit 2 (3 hours long) The second visit will occur in the clinic approximately 12 months from the date of the first visit. As with the first study visit, again both the person with Alzheimer's Disease/control participant and the caregiver/study partner will answer questions about their memory, quality of life, mood, and daily activities. Once again, the caregiver/study partner will be given a copy of the CCBC and asked to take it home and complete.
Both visits will take about three hours for the caregiver/study partner and about two hours for the person with dementia or control subject.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Couples including spouse or family member who spend at least 2-3 hours per day together
- Both must be cognitively intact
Key exclusion criteria (1 listed)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 25 Nov 2009.
Related trials for Alzheimer's Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
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.
Pamela Saunders, PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, 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 2 inclusion and 1 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 25 Nov 2009. 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.
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 25 Nov 2009.