Alzheimer's DiseaseADMITNCT01314950
Alzheimer's Disease Multiple Intervention Trial
A study testing Home based occupational therapy and Best practices primary care in people with Alzheimer's Disease, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Home based occupational therapy and Best practices primary care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2015
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Not a current patient within Wishard Health Services
- Does not speak English
- Currently enrolled in another study
- Non-community dwelling, or residing in a skilled nursing facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Wishard Health Services
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.
Read the detailed description
The proposed study builds on our findings from a previous clinical trial that demonstrated the effectiveness of collaborative care for older adults with Alzheimer's disease cared for in primary care practices. In the prior trial, we demonstrated that guideline-level medical care resulted in improved quality of care and improved behavioral and psychological symptoms over one year among patients and their caregivers. However, despite finding significant differences among study groups on Neuropsychiatric Inventory scores, we did not find a significant difference between groups in functional decline. Both study groups experienced a significant decline in function over 18 months. The current study proposes to test a home-based intervention specifically designed to slow the rate of functional decline among older adults with Alzheimer's disease.
In addition to building on our past research, the study also builds from recently reported research which demonstrated the short-term efficacy of home-based occupational therapy interventions among older adults with dementia. These trials show that older adults with dementia, including Alzheimer's disease, can both participate in and benefit from occupational therapy-based interventions delivered in the home.
The specific aim of this study is to conduct a two-year, randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention. We will test the primary hypothesis that subjects with Alzheimer's disease in the intervention group will have improved function at two years compared with the best practice primary care control group.
- Conditions
- Alzheimer's Disease
- Being tested
- Home based occupational therapy, Best practices primary care
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based occupational therapyBehavioural
An occupational therapist (OT) will deliver the home-based intervention. There are three cycles of intervention over two years, with each cycle delivering eight 60-90 minute home sessions. Cycle one takes place over 16 weeks, cycle two over 32 weeks, and cycle three over one year. Telephone calls take place in intervening weeks, with additional phone calls allowed to assist with problem solving and interval problems. At minimum, the OT will perform an assessment at the beginning of each cycle in order to tailor the home based component for individual dyads at each cycle. The OT will collaborate with the patients and caregivers to develop client centered goals with "homework" each week in order to encourage carryover of strategies, home environmental modifications, or home exercise programs.
Best practices primary careBehavioural
Collaborative care is provided by an advanced practice nurse working in collaborations with a family caregiver, the primary care physician, and geriatric medicine specialists. Caregivers complete a formal assessment of problematic behaviors to assess current symptoms and stressors, and the care manager makes recommendations based on these results and using standardized protocols. Protocols focus first on non-pharmacologic interventions. If these interventions fail, the care manager collaborates with the primary care physician and/or specialists to institute protocol-based drug therapy or other strategies. Patients and caregivers are also offered access to support groups.
| Study group | Role | What they receive |
|---|---|---|
| Best practices primary care | Active comparator | Best practices primary care encompasses the collaborative care intervention tested in a prior clinical trial (Callahan CM et al. JAMA 2006). Receives: Behavioral: Best practices primary care |
| Home based occupational therapy | Experimental | The intervention group receives all of the components of best practice primary care in addition to a home-based intervention designed to slow functional decline. Receives: Behavioral: Home based occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI)
Measured: 24 months
Secondary outcomes (13)
Short Physical Performance Battery (SPPB)
Includes Side by Side Stand, Semi-Tandem Stand, Tandem Stand, Repeated Chair Stands, and 3 or 4 meter walk
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Tandem Stand, eyes closed
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
One Leg Stand, eyes open
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Mini Mental State Examination
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Word List Learning
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Delayed Word List Recall
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Grip Strength
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Neuropsychiatric Inventory (NPI)
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Alzheimer's Disease Cooperative Studies Resource Use Scale
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
PHQ - 9
Depression
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
GAD - 7
Anxiety
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Comorbid Conditions
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Adverse Events
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Regenstrief Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher M Callahan, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314950
- Sponsor's protocol ID
- R01AG034946-01A1
- Other IDs
- R01AG034946-01A1
- Acronym
- ADMIT
- Status last verified
- Mar 2016
- First submitted
- 10 Mar 2011
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57. doi: 10.1001/jama.295.18.2148.
PubMed 16684985Callahan CM, Boustani M, Sachs GA, Hendrie HC. Integrating care for older adults with cognitive impairment. Curr Alzheimer Res. 2009 Aug;6(4):368-74. doi: 10.2174/156720509788929228.
PubMed 19689236Guerriero Austrom M, Damush TM, Hartwell CW, Perkins T, Unverzagt F, Boustani M, Hendrie HC, Callahan CM. Development and implementation of nonpharmacologic protocols for the management of patients with Alzheimer's disease and their families in a multiracial primary care setting. Gerontologist. 2004 Aug;44(4):548-53. doi: 10.1093/geront/44.4.548.
PubMed 15331812Callahan CM, Boustani MA, Schmid AA, LaMantia MA, Austrom MG, Miller DK, Gao S, Ferguson DY, Lane KA, Hendrie HC. Targeting Functional Decline in Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2017 Feb 7;166(3):164-171. doi: 10.7326/M16-0830. Epub 2016 Nov 22.
PubMed 27893087Callahan CM, Boustani MA, Schmid AA, Austrom MG, Miller DK, Gao S, Morris CS, Vogel M, Hendrie HC. Alzheimer's disease multiple intervention trial (ADMIT): study protocol for a randomized controlled clinical trial. Trials. 2012 Jun 27;13:92. doi: 10.1186/1745-6215-13-92.
PubMed 22737979
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease Multiple Intervention Trial
- ClinicalTrials.gov ID
- NCT01314950
- Acronym / sponsor ID
- ADMIT / R01AG034946-01A1
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Regenstrief Institute, Inc.
- Study start
- Jul 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Mar 2011 (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 study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.
Detailed description
The proposed study builds on our findings from a previous clinical trial that demonstrated the effectiveness of collaborative care for older adults with Alzheimer's disease cared for in primary care practices. In the prior trial, we demonstrated that guideline-level medical care resulted in improved quality of care and improved behavioral and psychological symptoms over one year among patients and their caregivers. However, despite finding significant differences among study groups on Neuropsychiatric Inventory scores, we did not find a significant difference between groups in functional decline. Both study groups experienced a significant decline in function over 18 months. The current study proposes to test a home-based intervention specifically designed to slow the rate of functional decline among older adults with Alzheimer's disease.
In addition to building on our past research, the study also builds from recently reported research which demonstrated the short-term efficacy of home-based occupational therapy interventions among older adults with dementia. These trials show that older adults with dementia, including Alzheimer's disease, can both participate in and benefit from occupational therapy-based interventions delivered in the home.
The specific aim of this study is to conduct a two-year, randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention. We will test the primary hypothesis that subjects with Alzheimer's disease in the intervention group will have improved function at two years compared with the best practice primary care control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best practices primary care | Active comparator | Behavioral: Best practices primary careBest practices primary care encompasses the collaborative care intervention tested in a prior clinical trial (Callahan CM et al. JAMA 2006). |
| Home based occupational therapy | Experimental | Behavioral: Home based occupational therapyThe intervention group receives all of the components of best practice primary care in addition to a home-based intervention designed to slow functional decline. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Not a current patient within Wishard Health Services
- Does not speak English
- Currently enrolled in another study
- Non-community dwelling, or residing in a skilled nursing facility
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 occupational therapyAn occupational therapist (OT) will deliver the home-based intervention. There are three cycles of intervention over two years, with each cycle delivering eight 60-90 minute home sessions. Cycle one takes place over 16 weeks, cycle two over 32 weeks, and cycle three over one year. Telephone calls take place in intervening weeks, with additional phone calls allowed to assist with problem solving and interval problems. At minimum, the OT will perform an assessment at the beginning of each cycle in order to tailor the home based component for individual dyads at each cycle. The OT will collaborate with the patients and caregivers to develop client centered goals with "homework" each week in order to encourage carryover of strategies, home environmental modifications, or home exercise programs. | Behavioural | Home based occupational therapy |
| Best practices primary careCollaborative care is provided by an advanced practice nurse working in collaborations with a family caregiver, the primary care physician, and geriatric medicine specialists. Caregivers complete a formal assessment of problematic behaviors to assess current symptoms and stressors, and the care manager makes recommendations based on these results and using standardized protocols. Protocols focus first on non-pharmacologic interventions. If these interventions fail, the care manager collaborates with the primary care physician and/or specialists to institute protocol-based drug therapy or other strategies. Patients and caregivers are also offered access to support groups. | Behavioural | Best practices primary care |
Primary outcome
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI)
Time frame: 24 months
13 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Tandem Stand, eyes closed
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
One Leg Stand, eyes open
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Mini Mental State Examination
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Word List Learning
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Delayed Word List Recall
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Grip Strength
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Neuropsychiatric Inventory (NPI)
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Alzheimer's Disease Cooperative Studies Resource Use Scale
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
PHQ - 9
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
GAD - 7
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Comorbid Conditions
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Adverse Events
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 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 8 Mar 2016.
- Background: PubMed 16684985Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57. doi: 10.1001/jama.295.18.2148.
- Background: PubMed 19689236Callahan CM, Boustani M, Sachs GA, Hendrie HC. Integrating care for older adults with cognitive impairment. Curr Alzheimer Res. 2009 Aug;6(4):368-74. doi: 10.2174/156720509788929228.
- Background: PubMed 15331812Guerriero Austrom M, Damush TM, Hartwell CW, Perkins T, Unverzagt F, Boustani M, Hendrie HC, Callahan CM. Development and implementation of nonpharmacologic protocols for the management of patients with Alzheimer's disease and their families in a multiracial primary care setting. Gerontologist. 2004 Aug;44(4):548-53. doi: 10.1093/geront/44.4.548.
- Derived from this study: PubMed 27893087Callahan CM, Boustani MA, Schmid AA, LaMantia MA, Austrom MG, Miller DK, Gao S, Ferguson DY, Lane KA, Hendrie HC. Targeting Functional Decline in Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2017 Feb 7;166(3):164-171. doi: 10.7326/M16-0830. Epub 2016 Nov 22.
- Derived from this study: PubMed 22737979Callahan CM, Boustani MA, Schmid AA, Austrom MG, Miller DK, Gao S, Morris CS, Vogel M, Hendrie HC. Alzheimer's disease multiple intervention trial (ADMIT): study protocol for a randomized controlled clinical trial. Trials. 2012 Jun 27;13:92. doi: 10.1186/1745-6215-13-92.
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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.
Christopher M Callahan, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based occupational therapy and Best practices primary care in people with Alzheimer's Disease, run by Indiana 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 0 inclusion and 4 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 8 Mar 2016. 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?
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (time frame: 24 months). 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 NCT01314950, which also lists 5 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 8 Mar 2016.