DementiaNCT03260608
Effectiveness of a Psychoeducation and Support Protocol by Phone in the Aid of Caregivers of Patients With Dementia.
A study testing Telesupport in people with Dementia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Dementias are neurodegenerative syndromes typical of the elderly population and causing a high degree of disability and sick of dependence on others for care. Caregivers of patients with dementia, especially those belonging to the same family suffer with high overhead and is often affected by losses in their own… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Telesupport
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2017to 20 Jun 2020
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- home caregivers
- female and of the same family as the patient
- dementia of any etiology and severity
- caregivers should be responsible for the patient for at least 40 hours per week and for a -minimum period of 6 months
- must have at least 4 years of formal study
Who cannot join
- caregivers with physical limitations that prevent the application of research instruments
- patients with significant functional impairment related to other diseases
- plans by the caregiver to place the patient in a long-term home in the next 6 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035903
Andressa H Pereira, CP, 5551997957558, andressahpereira@gmail.com
About this study
Official title: Randomized Clinical Assessment to Evaluate the Effectiveness of a Psychoeducation and Support Protocol by Telephone, in the Aid of Caregivers of Patients With Dementia in Specialized Ambulatory Accompanying
Dementias are neurodegenerative syndromes typical of the elderly population and causing a high degree of disability and sick of dependence on others for care. Caregivers of patients with dementia, especially those belonging to the same family suffer with high overhead and is often affected by losses in their own health. The aim of this study is to evaluate the efficacy of a psychoeducation and protocol support, conducted by telephone, in aid of patients with dementia caregivers in specialized outpatient treatment. It will be selected patients in outpatient specialized care. The primary outcome is the change in Zarit Scale.
Read the detailed description
Dementias are neurodegenerative syndromes typical of the elderly population and cause a high degree of incapacity and dependence of the patient in relation to the care of others. Caregivers of patients with dementia, especially those belonging to the same family, suffer from a high degree of overload, and are often affected by impairments in their own health. Previous studies have shown that telephone interventions for the assistance and guidance of these individuals have a positive impact on their own quality of life as well as on the family members under their care. Measures like this can also optimize specialized services and facilitate the search for medical help when needed.
In this way, the present study aims to evaluate the efficacy of a psychoeducation and support protocol, performed by telephone, to assist caregivers of patients with dementia under specialized outpatient follow-up.
Patients will be divided into two groups. Participants in the intervention group, in addition to the usual primary health care, will receive weekly telephone contacts over a period of eight weeks, previously scheduled with psychoeducational guidelines and support in the management of their relatives and with dementia. The control group will receive the usual follow-up at the in primary health care. Both group will received a prited materials about problematic behavior.
Considering the prevalence and impact of dementia syndromes, it is necessary to conduct studies that are directed at reducing the burden and promoting the information and care of the caregivers of patients with dementia, also providing an improvement in the quality of care. The present project brings as scientific contribution an innovative approach to the reality of our country, with great potential to become an alternative, cost-effective and easily accessible measure for the assistance of people with dementia and their relatives and caregivers.
- Conditions
- Dementia
- Being tested
- Telesupport
- Keywords
- dementia, deficits, burden, caregivers, telemedicine.
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelesupportBehavioural
In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Telesupport: eight weekly phone calls of psychoeducation and support on the illness of their relatives. Patients will also receive printed materials on problematic behaviors about dementia. Receives: Behavioral: Telesupport |
| Control | No intervention | No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the caregiver's level of burden
Zarit Burden Interview
Measured: Week 9
Change from baseline in the caregiver's level of burden
Zarit Burden Interview
Measured: Week 18
Secondary outcomes (10)
Change from baseline in the caregivers's depressive symptoms
Beck Depression Inventory
Measured: Week 9
Change from baseline in the caregivers's depressive symptoms
Beck Depression Inventory
Measured: Week 18
Change from baseline in the caregivers's anxiety symptoms
Beck Anxiety Inventory
Measured: Week 9
Change from baseline in the caregivers's anxiety symptoms
Beck Anxiety Inventory
Measured: Week 18
Change from baseline in the caregivers's quality of life
Quality of Life Questionnaire - WHOQOL
Measured: Week 9
Change from baseline in the caregivers's quality of life
Quality of Life Questionnaire - WHOQOL
Measured: Week 18
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Neuropsychiatric Inventory - NPI
Measured: Week 9
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Neuropsychiatric Inventory - NPI
Measured: Week 18
Change from baseline in the patient functionality
Pfeffer Functional Activities Questionnaire
Measured: Week 9
Change from baseline in the patient functionality
Pfeffer Functional Activities Questionnaire
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start15 Jan 2017
- Primary completion15 Apr 2020 (estimated)
- Study completion20 Jun 2020 (estimated)
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will select 148 caregivers. Patients will be divided into two groups, both groups will receive printed materials about problematics behaviors in dementia. Participants in the intervention group will receive weekly telephone contacts over a period of eight weeks, previously scheduled with psychoeducational and support in the management of their relatives with dementia. Caregivers in the intervention group will have access to a number of phones to spontaneously contact specific guidelines during the eight weeks of intervention. Patients from both groups will be interviewed in the baseline, at 8 weeks and 16 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Artur S Schuh, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260608
- Sponsor's protocol ID
- 17-0326
- Status last verified
- Jan 2020
- First submitted
- 16 Aug 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Assessment to Evaluate the Effectiveness of a Psychoeducation and Support Protocol by Telephone, in the Aid of Caregivers of Patients With Dementia in Specialized Ambulatory Accompanying
- ClinicalTrials.gov ID
- NCT03260608
- Acronym / sponsor ID
- 17-0326
- Conditions
- Dementia
- Keywords
- dementia, deficits, burden, caregivers, telemedicine.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 24 Aug 2017 (actual)
- 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.
Dementias are neurodegenerative syndromes typical of the elderly population and causing a high degree of disability and sick of dependence on others for care. Caregivers of patients with dementia, especially those belonging to the same family suffer with high overhead and is often affected by losses in their own health. The aim of this study is to evaluate the efficacy of a psychoeducation and protocol support, conducted by telephone, in aid of patients with dementia caregivers in specialized outpatient treatment. It will be selected patients in outpatient specialized care. The primary outcome is the change in Zarit Scale.
Detailed description
Dementias are neurodegenerative syndromes typical of the elderly population and cause a high degree of incapacity and dependence of the patient in relation to the care of others. Caregivers of patients with dementia, especially those belonging to the same family, suffer from a high degree of overload, and are often affected by impairments in their own health. Previous studies have shown that telephone interventions for the assistance and guidance of these individuals have a positive impact on their own quality of life as well as on the family members under their care. Measures like this can also optimize specialized services and facilitate the search for medical help when needed.
In this way, the present study aims to evaluate the efficacy of a psychoeducation and support protocol, performed by telephone, to assist caregivers of patients with dementia under specialized outpatient follow-up.
Patients will be divided into two groups. Participants in the intervention group, in addition to the usual primary health care, will receive weekly telephone contacts over a period of eight weeks, previously scheduled with psychoeducational guidelines and support in the management of their relatives and with dementia. The control group will receive the usual follow-up at the in primary health care. Both group will received a prited materials about problematic behavior.
Considering the prevalence and impact of dementia syndromes, it is necessary to conduct studies that are directed at reducing the burden and promoting the information and care of the caregivers of patients with dementia, also providing an improvement in the quality of care. The present project brings as scientific contribution an innovative approach to the reality of our country, with great potential to become an alternative, cost-effective and easily accessible measure for the assistance of people with dementia and their relatives and caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will select 148 caregivers. Patients will be divided into two groups, both groups will receive printed materials about problematics behaviors in dementia. Participants in the intervention group will receive weekly telephone contacts over a period of eight weeks, previously scheduled with psychoeducational and support in the management of their relatives with dementia. Caregivers in the intervention group will have access to a number of phones to spontaneously contact specific guidelines during the eight weeks of intervention. Patients from both groups will be interviewed in the baseline, at 8 weeks and 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: TelesupportTelesupport: eight weekly phone calls of psychoeducation and support on the illness of their relatives. Patients will also receive printed materials on problematic behaviors about dementia. |
| Control | No intervention | –No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- home caregivers
- female and of the same family as the patient
- dementia of any etiology and severity
- caregivers should be responsible for the patient for at least 40 hours per week and for a -minimum period of 6 months
- must have at least 4 years of formal study
Key exclusion criteria (3 listed)
- caregivers with physical limitations that prevent the application of research instruments
- patients with significant functional impairment related to other diseases
- plans by the caregiver to place the patient in a long-term home in the next 6 months.
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 |
|---|---|---|
| TelesupportIn the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes. | Behavioural | Intervention |
Primary outcome
Change from baseline in the caregiver's level of burden
Time frame: Week 9
Zarit Burden Interview
Change from baseline in the caregiver's level of burden
Time frame: Week 18
Zarit Burden Interview
10 secondary outcomes
Change from baseline in the caregivers's depressive symptoms
Time frame: Week 9
Change from baseline in the caregivers's depressive symptoms
Time frame: Week 18
Change from baseline in the caregivers's anxiety symptoms
Time frame: Week 9
Change from baseline in the caregivers's anxiety symptoms
Time frame: Week 18
Change from baseline in the caregivers's quality of life
Time frame: Week 9
Change from baseline in the caregivers's quality of life
Time frame: Week 18
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Time frame: Week 9
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Time frame: Week 18
Change from baseline in the patient functionality
Time frame: Week 9
Change from baseline in the patient functionality
Time frame: Week 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Artur S Schuh, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telesupport in people with Dementia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 5 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 14 Jan 2020. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Artur S Schuh, PhD (33598520, schuh.afs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the caregiver's level of burden (time frame: Week 9). 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 14 Jan 2020.