Alzheimer DiseasePhase 2/3NCT00908492
Supporting Caregivers of Persons With Dementia: A Pilot Study
A Phase 2/3 study testing Environmental Skill Building in people with Alzheimer Disease and Dementia, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this study is to pilot the home Environmental Skill-Building Program (ESP) and an educational control intervention with persons with dementia and their caregivers (n=40) in preparation for a larger double-blind randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Environmental Skill Building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Sep 2011
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The caregiver must be the primary caregiver
- Caregiver reports that the care recipient has at least one limitation in basic activities of daily living (ADL) or two dependencies in instrumental activities of daily living (IADLs)
- The caregiver must:
- provide at least 2 hours of care per day
- be caregiving for at least 6 months and
- be at least 21 years of age
- The care recipients need to have a diagnosis of dementia
Who cannot join
- Caregiver:
- does not live with the care recipient
- has poor health (undergoing treatments for cancer, hospitalized more than three times in past year)
- planning to place care recipient in long term care within the next year
- Care recipients who are confined to bed most of the day or are minimally-responsive to touch or the environment are excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Environmental Skill Building Program for Dementia Caregivers
The purpose of this study is to pilot the home Environmental Skill-Building Program (ESP) and an educational control intervention with persons with dementia and their caregivers (n=40) in preparation for a larger double-blind randomized controlled trial. Caregivers of persons with dementia often deal with difficult behaviors. The ESP is an occupational therapy intervention that helps caregivers adapt to their environment and build care-giving skills. The areas addressed include changes to the home set-up, adaptive equipment, instruction in strategies of problem-solving, energy conservation, safe task performance, and fall recovery techniques. A trial is needed with methodological rigor and to determine if the intervention is feasible in the Canadian health care system. Results will contribute to understanding how caregivers and people with dementia can be supported in their home environments.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Education Control, Environmental Skill Building
- Keywords
- Randomized control trial, Dementia caregivers, Occupational Therapy, Caregivers
- 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.
Education ControlBehavioural
Caregiver participants are provided with information about caregiver stress and discuss it individually with an interventionist who visits the home. The control intervention involves 5 visits over 6 months.
Environmental Skill BuildingBehavioural
The ESP intervention addresses home modifications and training in their use, instruction in strategies of problem-solving, energy conservation, safe task performance, fall recovery techniques, and balance and muscle strength training. Intervention is individualized for target areas identified in the initial client assessment and caregiver interview. The intervention involves using a problem solving approach and client-centred focus and the intervention assessment tools are individualized measures which determine the goals identified by the caregiver. It involves 5 visits over 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Education Control | Active comparator | Not described Receives: Behavioral: Education Control |
| Environmental Skill Building | Experimental | Not described Receives: Behavioral: Environmental Skill Building |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Memory and Behavior Problem Checklist
Measured: 0, 6, 9 months
Secondary outcomes (5)
Disability Assessment for Dementia
Measured: 0, 6, 9 months
Number of caregiving assistance hours
Measured: 0, 6, 9 months
Short Zarit Burden Interview
Measured: 0, 6, 9 months
Task Management Strategy Index
Measured: 0, 6, 9 months
Perceived Change Scale
Measured: 0, 6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Responsible party
- Principal investigator, Lori Letts, McMaster University
- Investigators
- Lori Letts, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908492
- Sponsor's protocol ID
- ASC1050
- Status last verified
- Apr 2015
- First submitted
- 26 May 2009
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Environmental Skill Building Program for Dementia Caregivers
- ClinicalTrials.gov ID
- NCT00908492
- Acronym / sponsor ID
- ASC1050
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Randomized control trial, Dementia caregivers, Occupational Therapy, Caregivers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 May 2009 (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 pilot the home Environmental Skill-Building Program (ESP) and an educational control intervention with persons with dementia and their caregivers (n=40) in preparation for a larger double-blind randomized controlled trial. Caregivers of persons with dementia often deal with difficult behaviors. The ESP is an occupational therapy intervention that helps caregivers adapt to their environment and build care-giving skills. The areas addressed include changes to the home set-up, adaptive equipment, instruction in strategies of problem-solving, energy conservation, safe task performance, and fall recovery techniques. A trial is needed with methodological rigor and to determine if the intervention is feasible in the Canadian health care system. Results will contribute to understanding how caregivers and people with dementia can be supported in their home environments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Control | Active comparator | Behavioral: Education Control |
| Environmental Skill Building | Experimental | Behavioral: Environmental Skill Building |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The caregiver must be the primary caregiver
- Caregiver reports that the care recipient has at least one limitation in basic activities of daily living (ADL) or two dependencies in instrumental activities of daily living (IADLs)
- The caregiver must:
- The care recipients need to have a diagnosis of dementia
Key exclusion criteria (5 listed)
- Caregiver:
- Care recipients who are confined to bed most of the day or are minimally-responsive to touch or the environment are excluded
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 |
|---|---|---|
| Education ControlCaregiver participants are provided with information about caregiver stress and discuss it individually with an interventionist who visits the home. The control intervention involves 5 visits over 6 months. | Behavioural | Education Control |
| Environmental Skill BuildingThe ESP intervention addresses home modifications and training in their use, instruction in strategies of problem-solving, energy conservation, safe task performance, fall recovery techniques, and balance and muscle strength training. Intervention is individualized for target areas identified in the initial client assessment and caregiver interview. The intervention involves using a problem solving approach and client-centred focus and the intervention assessment tools are individualized measures which determine the goals identified by the caregiver. It involves 5 visits over 6 months. | Behavioural | Environmental Skill Building |
Primary outcome
Revised Memory and Behavior Problem Checklist
Time frame: 0, 6, 9 months
5 secondary outcomes
Disability Assessment for Dementia
Time frame: 0, 6, 9 months
Number of caregiving assistance hours
Time frame: 0, 6, 9 months
Short Zarit Burden Interview
Time frame: 0, 6, 9 months
Task Management Strategy Index
Time frame: 0, 6, 9 months
Perceived Change Scale
Time frame: 0, 6, 9 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 7 Apr 2015.
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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.
Lori Letts principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Environmental Skill Building in people with Alzheimer Disease and Dementia, run by McMaster University at 1 site in Canada.
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 7 inclusion and 5 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 7 Apr 2015. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Revised Memory and Behavior Problem Checklist (time frame: 0, 6, 9 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 7 Apr 2015.