Alzheimer's DiseasePhase 1NCT00259467
Project TAP: Tailored Activities Project
A Phase 1 study testing Home-Based Behavorial Intervention in people with Alzheimer's Disease, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Specific Aims 1. Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months 2. Evaluate acceptance of and engagement in activities in persons with dementia 3. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Home-Based Behavorial Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jan 2007
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Care Recipient
- English Speaking
- NINCDS-ADRDA diagnosis[physician generated of dementia or mini-mental state examination score of less than or equal to 23;3] Able to feel self; and participates in at least 2 other activities of daily living[ADLs-Bathing, Dressing, Grooming, Toileting, Transferring from bed to chair] As reported by caregiver.
- Caregiver
- English Speaking
- Family member 21 years of age or older [male or female]
Show all 11Show fewer
- Lives with Care Recipient
- Has telephone in the home
- Plans to live in area for 8 months
- Indicated willingness to learn new approaches by which to engage care recipient in meaningful activities
- Provides 4 or more hours a day directly caring or providing for care recipient
Who cannot join
- Care Recipient
- Has Schizophrenia or Bi-Polar Disorder
- Their Dementia is secondary to probable head trauma
- Their MMSE score is equal to zero and they are bed bound, defined as confinement to bed or chair for at least 22 hours a day for at least 4 of 7 days
- They are not responsive to their environment
- Caregiver
- Are currently involved in another clinical trial of psycho-social or educational interventions for caregivers
- Are planning to place their family member in a nursing home within the next 8 months. Also, the care recipient/caregiver dyad will be excluded if either caregiver or care recipient: 1) has a terminal illness with life expectancy less than 8 months 2)is in active treatment for cancer or 3) has had greater than 3 acute medical hospitalizations within the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Tailored Activity to Improve Affect in Dementia
Specific Aims
- Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months
- Evaluate acceptance of and engagement in activities in persons with dementia
- Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months.
- Evaluate caregiver skills acquisition, acceptance of and compliance to intervention techniques.
- Conditions
- Alzheimer's Disease
- Being tested
- Home-Based Behavorial Intervention
- Keywords
- Activity, Dementia, Caregiving
- Medical subject headings
- Alzheimer Disease, Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Behavorial InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral occurrence
Care recipient depressive mood
Caregiver upset
Secondary outcomes (1)
Activity engagement and vigilance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startFeb 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Investigators
- Laura N Gitlin, Ph.D, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259467
- Sponsor's protocol ID
- R21MH069425
- Status last verified
- Aug 2010
- First submitted
- 28 Nov 2005
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Gitlin LN, Winter L, Vause Earland T, Adel Herge E, Chernett NL, Piersol CV, Burke JP. The Tailored Activity Program to reduce behavioral symptoms in individuals with dementia: feasibility, acceptability, and replication potential. Gerontologist. 2009 Jun;49(3):428-39. doi: 10.1093/geront/gnp087. Epub 2009 May 6.
PubMed 19420314
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Activity to Improve Affect in Dementia
- ClinicalTrials.gov ID
- NCT00259467
- Acronym / sponsor ID
- R21MH069425
- Conditions
- Alzheimer's Disease
- Keywords
- Activity, Dementia, Caregiving
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Jan 2007
- First posted
- 29 Nov 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.
Specific Aims
- Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months
- Evaluate acceptance of and engagement in activities in persons with dementia
- Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months.
- Evaluate caregiver skills acquisition, acceptance of and compliance to intervention techniques.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Care Recipient
- English Speaking
- NINCDS-ADRDA diagnosis[physician generated of dementia or mini-mental state examination score of less than or equal to 23;3] Able to feel self; and participates in at least 2 other activities of daily living[ADLs-Bathing, Dressing, Grooming, Toileting, Transferring from bed to chair] As reported by caregiver.
- Caregiver
- English Speaking
Key exclusion criteria (8 listed)
- Care Recipient
- Has Schizophrenia or Bi-Polar Disorder
- Their Dementia is secondary to probable head trauma
- Their MMSE score is equal to zero and they are bed bound, defined as confinement to bed or chair for at least 22 hours a day for at least 4 of 7 days
- They are not responsive to their environment
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 |
|---|---|---|
| Home-Based Behavorial Intervention | Behavioural | – |
Primary outcome
Behavioral occurrence
Care recipient depressive mood
Caregiver upset
1 secondary outcome
Activity engagement and vigilance
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 Aug 2010.
- Derived from this study: PubMed 19420314Gitlin LN, Winter L, Vause Earland T, Adel Herge E, Chernett NL, Piersol CV, Burke JP. The Tailored Activity Program to reduce behavioral symptoms in individuals with dementia: feasibility, acceptability, and replication potential. Gerontologist. 2009 Jun;49(3):428-39. doi: 10.1093/geront/gnp087. Epub 2009 May 6.
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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.
Laura N Gitlin, Ph.D principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Home-Based Behavorial Intervention in people with Alzheimer's Disease, run by Thomas Jefferson University 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 11 inclusion and 8 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 Aug 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Behavioral occurrence. The study lists 3 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 NCT00259467, which also lists 1 linked publication.
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 Aug 2010.