CaregiversPTC-dementiaNCT02697721
Powerful Tools for Caregivers of Dementia Patients
A study testing Powerful Tools for Caregivers in people with Caregivers and Dementia, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study is to examine if a psycho-educational intervention for caregivers of patients with dementia will decrease caregiver burden, increase caregiver physical activity, and decrease the reporting of behavioral and psychological symptoms of the person with dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Dementia, Alzheimer Disease
- What is being tested?
- Powerful Tools for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregiver lives with or provides care for the care recipient for an average of at least 4 hours per day.
- Care for an individual with a physician diagnosis of dementia (mild to moderate stage of dementia).
- Care for a care recipient who experiences behavioral symptoms that bother or upset the caregiver moderately, very much, or extremely. The occurrence of problematic behaviors and caregivers' reactions will be assessed with 6-items adapted from the Revised Memory and Behavior Problems Checklist (Teri et al 1992).
Who cannot join
- Care for a care recipient who is bed-bound or has advanced dementia: Functional Assessment Staging (FAST)(Sclan \& Reisberg 1992) stage 7.
- Caregiver's cognitive, hearing, visual, or other physical impairments lead to difficulty with informed consent process, assessment, or participation in the intervention.
- Caregiver who is involved in another trial that addresses caregiver burden or behavioral expressions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University College of Medicine
Tallahassee, Florida, 32306
About this study
Official title: Optimization of "Powerful Tools for Caregivers" of Dementia Patients
The purpose of this study is to examine if a psycho-educational intervention for caregivers of patients with dementia will decrease caregiver burden, increase caregiver physical activity, and decrease the reporting of behavioral and psychological symptoms of the person with dementia.
- Conditions
- Caregivers, Dementia, Alzheimer Disease
- Being tested
- Powerful Tools for Caregivers, Control with delayed intervention
- Keywords
- Caregivers, Behavioral symptoms, Dementia, Alzheimer disease, Physical activity, Depressive symptoms, Powerful Tools for Caregivers, Chronic Disease Self-Management Program
- Medical subject headings
- Dementia, Alzheimer Disease, Behavioral Symptoms, Motor Activity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powerful Tools for CaregiversBehavioural
Powerful Tools for Caregivers is a 6-week psychoeducational program. Each week the caregivers will attend a 90-minute workshop in a group setting. These sessions will be co-led by two trained and certified leaders who follow the scripted program. In addition to providing education about caregiving and the importance of self-care, the classes will help caregivers develop self-care tools to manage personal stress and improve communication skills.
Control with delayed interventionOther
Control with delayed intervention
| Study group | Role | What they receive |
|---|---|---|
| Powerful Tools for Caregivers | Experimental | A 6-week psycho-educational program Receives: Behavioral: Powerful Tools for Caregivers |
| Control group, delayed intervention | Other | Control group with delayed intervention Receives: Other: Control with delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
Zarit Caregiver Burden Scale scores
Measured: 6 weeks
Frequency and reaction to care recipient behavioral and psychological symptoms of dementia
Revised Memory and Behavior Problems Checklist scores
Measured: 6 weeks
Frequency of care recipient agitated behaviors
Cohen-Mansfield Agitation Inventory scores
Measured: 6 weeks
Secondary outcomes (7)
Activity parameters as assessed by FitBit
Measured: 6 weeks
Depressive symptoms
Center for Epidemiologic Studies Depression Scale scores
Measured: 6 weeks
Caregiving Self-Efficacy
Caregiving Self-Efficacy Scale scores
Measured: 6 weeks
Self-rated health
Single item "In general, would you say your health is...." with response options from 1= poor to 5=excellent.
Measured: 6 weeks
Life satisfaction
Single item "I am satisfied with my life" with response options from 0=Strongly disagree to 4=Strongly agree
Measured: 6 weeks
Perceived change
Perceived Change Index score
Measured: 6 weeks
Neuropsychiatric symptoms in care recipients
Neuropsychiatric Inventory score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion30 May 2018
- Study completionFeb 2019
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 CaregiversStudies of the same condition, open and under way.
- More trials run by Florida State 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Principal investigator, Antonio Terracciano, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697721
- Sponsor's protocol ID
- 6AZ09
- Acronym
- PTC-dementia
- Status last verified
- Jan 2021
- First submitted
- 17 Feb 2016
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Terracciano A, Artese A, Yeh J, Edgerton L, Granville L, Aschwanden D, Luchetti M, Glueckauf RL, Stephan Y, Sutin AR, Katz P. Effectiveness of Powerful Tools for Caregivers on Caregiver Burden and on Care Recipient Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial. J Am Med Dir Assoc. 2020 Aug;21(8):1121-1127.e1. doi: 10.1016/j.jamda.2019.11.011. Epub 2019 Dec 19.
PubMed 31866419
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of "Powerful Tools for Caregivers" of Dementia Patients
- ClinicalTrials.gov ID
- NCT02697721
- Acronym / sponsor ID
- PTC-dementia / 6AZ09
- Conditions
- Caregivers, Dementia, Alzheimer Disease
- Keywords
- Caregivers, Behavioral symptoms, Dementia, Alzheimer disease, Physical activity, Depressive symptoms, Powerful Tools for Caregivers, Chronic Disease Self-Management Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 3 Mar 2016 (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 examine if a psycho-educational intervention for caregivers of patients with dementia will decrease caregiver burden, increase caregiver physical activity, and decrease the reporting of behavioral and psychological symptoms of the person with dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powerful Tools for Caregivers | Experimental | Behavioral: Powerful Tools for CaregiversA 6-week psycho-educational program |
| Control group, delayed intervention | Other | Other: Control with delayed interventionControl group with delayed intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caregiver lives with or provides care for the care recipient for an average of at least 4 hours per day.
- Care for an individual with a physician diagnosis of dementia (mild to moderate stage of dementia).
- Care for a care recipient who experiences behavioral symptoms that bother or upset the caregiver moderately, very much, or extremely. The occurrence of problematic behaviors and caregivers' reactions will be assessed with 6-items adapted from the Revised Memory and Behavior Problems Checklist (Teri et al 1992).
Key exclusion criteria (3 listed)
- Care for a care recipient who is bed-bound or has advanced dementia: Functional Assessment Staging (FAST)(Sclan \& Reisberg 1992) stage 7.
- Caregiver's cognitive, hearing, visual, or other physical impairments lead to difficulty with informed consent process, assessment, or participation in the intervention.
- Caregiver who is involved in another trial that addresses caregiver burden or behavioral expressions.
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 |
|---|---|---|
| Powerful Tools for CaregiversPowerful Tools for Caregivers is a 6-week psychoeducational program. Each week the caregivers will attend a 90-minute workshop in a group setting. These sessions will be co-led by two trained and certified leaders who follow the scripted program. In addition to providing education about caregiving and the importance of self-care, the classes will help caregivers develop self-care tools to manage personal stress and improve communication skills. | Behavioural | Powerful Tools for Caregivers |
| Control with delayed interventionControl with delayed intervention | Other | Control group, delayed intervention |
Primary outcome
Caregiver Burden
Time frame: 6 weeks
Zarit Caregiver Burden Scale scores
Frequency and reaction to care recipient behavioral and psychological symptoms of dementia
Time frame: 6 weeks
Revised Memory and Behavior Problems Checklist scores
Frequency of care recipient agitated behaviors
Time frame: 6 weeks
Cohen-Mansfield Agitation Inventory scores
7 secondary outcomes
Activity parameters as assessed by FitBit
Time frame: 6 weeks
Depressive symptoms
Time frame: 6 weeks
Caregiving Self-Efficacy
Time frame: 6 weeks
Self-rated health
Time frame: 6 weeks
Life satisfaction
Time frame: 6 weeks
Perceived change
Time frame: 6 weeks
Neuropsychiatric symptoms in care recipients
Time frame: 6 weeks
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 29 Jan 2021.
- Results publication: PubMed 31866419Terracciano A, Artese A, Yeh J, Edgerton L, Granville L, Aschwanden D, Luchetti M, Glueckauf RL, Stephan Y, Sutin AR, Katz P. Effectiveness of Powerful Tools for Caregivers on Caregiver Burden and on Care Recipient Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial. J Am Med Dir Assoc. 2020 Aug;21(8):1121-1127.e1. doi: 10.1016/j.jamda.2019.11.011. Epub 2019 Dec 19.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powerful Tools for Caregivers in people with Caregivers and Dementia, run by Florida State 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 3 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: finished, as of the sponsor's last update on 29 Jan 2021. 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?
Caregiver Burden (time frame: 6 weeks). 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 NCT02697721, 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 29 Jan 2021.