Alzheimer's DiseaseI-careNCT02397980
Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
A study testing Behavioral intervention in people with Alzheimer's Disease and Dementia, run by Ewha Womans University Mokdong Hospital.
Trial summary
The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2016
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-80years old
- Caregivers who spend their own time with dementia patients over 4 hours a day
- caregiver distress scores >= 2
- caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10~26)
Who cannot join
- illiterate
- severe hearing/visual acuity difficulty
- cognitive impairment
About this study
Official title: A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).
Read the detailed description
This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The intervention program includes not only the knowledge of dementia and how to manage behavioral problems of patients with dementia but also individual psychological counselling about caregiver's distress. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS). Secondary outcomes are changes in scores of neuropsychiatric inventory and Korean -instrumental Activities of Daily Living of patients as well as depression scores of caregivers.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Behavioral intervention
- Keywords
- 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.
Behavioral interventionBehavioural
- What the dementia is
- How to deal with behavioral problems in patients with dementia
- How to manage caregiver's stress
- How to care dementic patients as well as caregivers themselves
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Basic information about dementia |
| Behavioral intervention | Active comparator | Individual, 90 min a day, with an interval of 2 weeks
* Education about dementia
* psychological counselling
* cognitive behavioral therapy Receives: Behavioral: Behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Zaret's Burden Inventory (ZBI)
Measured: baseline/10-12 week (after intervention)
Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
Philadelphia Geriatric Center for Moral Scale (PGCMS)
Measured: baseline/10-12 week (after intervention)
Secondary outcomes (2)
Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory
Neuropsychiatry inventory
Measured: baseline/10-12 week (after intervention)
Changes in Depression of caregivers as assessed by the geriatric depression scale
Geriatric depression scale
Measured: baseline/10-12 week (after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Jee Hyang, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397980
- Sponsor's protocol ID
- EUMC2014-12-028
- Acronym
- I-care
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2015
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia
- ClinicalTrials.gov ID
- NCT02397980
- Acronym / sponsor ID
- I-care / EUMC2014-12-028
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Caregivers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Mar 2015 (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 investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).
Detailed description
This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The intervention program includes not only the knowledge of dementia and how to manage behavioral problems of patients with dementia but also individual psychological counselling about caregiver's distress. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS). Secondary outcomes are changes in scores of neuropsychiatric inventory and Korean -instrumental Activities of Daily Living of patients as well as depression scores of caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Basic information about dementia |
| Behavioral intervention | Active comparator | Behavioral: Behavioral interventionIndividual, 90 min a day, with an interval of 2 weeks * Education about dementia * psychological counselling * cognitive behavioral therapy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 30-80years old
- Caregivers who spend their own time with dementia patients over 4 hours a day
- caregiver distress scores >= 2
- caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10~26)
Key exclusion criteria (3 listed)
- illiterate
- severe hearing/visual acuity difficulty
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral intervention* What the dementia is * How to deal with behavioral problems in patients with dementia * How to manage caregiver's stress * How to care dementic patients as well as caregivers themselves | Behavioural | Behavioral intervention |
Primary outcome
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Time frame: baseline/10-12 week (after intervention)
Zaret's Burden Inventory (ZBI)
Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
Time frame: baseline/10-12 week (after intervention)
Philadelphia Geriatric Center for Moral Scale (PGCMS)
2 secondary outcomes
Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory
Time frame: baseline/10-12 week (after intervention)
Changes in Depression of caregivers as assessed by the geriatric depression scale
Time frame: baseline/10-12 week (after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral intervention in people with Alzheimer's Disease and Dementia, run by Ewha Womans University Mokdong Hospital.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI) (time frame: baseline/10-12 week (after intervention)). 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?
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 Mar 2015.