DementiaNCT03015428
"Living Together With Dementia"_Creation and Validation of a Training Program for Family Caregivers of People With Dementia to Live at Home
A study testing psychoeducation in people with Dementia, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial summary
This study aims to experimentally evaluate the training program for family caregivers of people with dementia_"Living together 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
- Dementia
- What is being tested?
- psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be primary caregiver of the person with dementia
- Be able to read and write
- Carers of peolpe with dementia in initial or moderate stage
Who cannot join
- The person with dementia have severe mental pathologies associated
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to experimentally evaluate the training program for family caregivers of people with dementia_"Living together with Dementia."
Read the detailed description
This study will begin in March 2016, with the initial assessment of family caregivers of people with dementia.
These were recruited through hospital neurology clinic and must comply with a set of pre-established criteria.
It is expected a total of 20 participants in the study (10 in the experimental group and 10 in control group).
Interventions will take place over the months of March and April. The final evaluation is scheduled for late April and the follow up to July 2016.
an evaluation document itself for this study was built.
- Conditions
- Dementia
- Being tested
- psychoeducation
- Keywords
- Family caregivers, training programme, dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationOther
Providing knowledge and skills development in family caregivers of people with dementia, through a structured psychoeducational programme
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Experimental | Interventions:
Give information Teach and train strategies Receives: Other: psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Overload Scale
Measured: 7 weeks
Carers Assessment Satisfaction Index
Measured: 7 weeks
Carers Assessment Difficulties Index
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lia Sousa, Centro Hospitalar De São João, E.P.E.
- Investigators
- Lia Sousa, Master, Principal investigator, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015428
- Sponsor's protocol ID
- LTWD1
- Status last verified
- Jan 2017
- First submitted
- 10 Apr 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Living Together With Dementia"_Creation and Validation of a Training Program for Family Caregivers of People With Dementia to Live at Home
- ClinicalTrials.gov ID
- NCT03015428
- Acronym / sponsor ID
- LTWD1
- Conditions
- Dementia
- Keywords
- Family caregivers, training programme, dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jan 2017 (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.
This study aims to experimentally evaluate the training program for family caregivers of people with dementia_"Living together with Dementia."
Detailed description
This study will begin in March 2016, with the initial assessment of family caregivers of people with dementia.
These were recruited through hospital neurology clinic and must comply with a set of pre-established criteria.
It is expected a total of 20 participants in the study (10 in the experimental group and 10 in control group).
Interventions will take place over the months of March and April. The final evaluation is scheduled for late April and the follow up to July 2016.
an evaluation document itself for this study was built.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Other: psychoeducationInterventions: Give information Teach and train strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be primary caregiver of the person with dementia
- Be able to read and write
- Carers of peolpe with dementia in initial or moderate stage
Key exclusion criteria (1 listed)
- The person with dementia have severe mental pathologies associated
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 |
|---|---|---|
| psychoeducationProviding knowledge and skills development in family caregivers of people with dementia, through a structured psychoeducational programme | Other | Psychoeducation |
Primary outcome
Caregiver Overload Scale
Time frame: 7 weeks
Carers Assessment Satisfaction Index
Time frame: 7 weeks
Carers Assessment Difficulties Index
Time frame: 7 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 10 Jan 2017.
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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.
Lia Sousa, Master principal investigator
Centro Hospitalar De São João, E.P.E.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation in people with Dementia, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
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 1 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 10 Jan 2017. 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 Portugal. 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 Overload Scale (time frame: 7 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?
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 10 Jan 2017.