Effectiveness of a Psychoeducation and Support Protocol by Phone in the Aid of Caregivers of Patients With Dementia.
Primary Purpose
Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Telesupport
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring dementia, deficits, burden, caregivers, telemedicine.
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team.
Outcomes
Primary Outcome Measures
Change from baseline in the caregiver's level of burden
Zarit Burden Interview
Change from baseline in the caregiver's level of burden
Zarit Burden Interview
Secondary Outcome Measures
Change from baseline in the caregivers's depressive symptoms
Beck Depression Inventory
Change from baseline in the caregivers's depressive symptoms
Beck Depression Inventory
Change from baseline in the caregivers's anxiety symptoms
Beck Anxiety Inventory
Change from baseline in the caregivers's anxiety symptoms
Beck Anxiety Inventory
Change from baseline in the caregivers's quality of life
Quality of Life Questionnaire - WHOQOL
Change from baseline in the caregivers's quality of life
Quality of Life Questionnaire - WHOQOL
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Neuropsychiatric Inventory - NPI
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Neuropsychiatric Inventory - NPI
Change from baseline in the patient functionality
Pfeffer Functional Activities Questionnaire
Change from baseline in the patient functionality
Pfeffer Functional Activities Questionnaire
Full Information
NCT ID
NCT03260608
First Posted
August 16, 2017
Last Updated
January 10, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03260608
Brief Title
Effectiveness of a Psychoeducation and Support Protocol by Phone in the Aid of Caregivers of Patients With Dementia.
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
April 15, 2020 (Anticipated)
Study Completion Date
June 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, deficits, burden, caregivers, telemedicine.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The individual who evaluates the outcome(s) of interest in this case the applicators of scales and questionnaires
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team.
Intervention Type
Behavioral
Intervention Name(s)
Telesupport
Intervention Description
In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.
Primary Outcome Measure Information:
Title
Change from baseline in the caregiver's level of burden
Description
Zarit Burden Interview
Time Frame
Week 9
Title
Change from baseline in the caregiver's level of burden
Description
Zarit Burden Interview
Time Frame
Week 18
Secondary Outcome Measure Information:
Title
Change from baseline in the caregivers's depressive symptoms
Description
Beck Depression Inventory
Time Frame
Week 9
Title
Change from baseline in the caregivers's depressive symptoms
Description
Beck Depression Inventory
Time Frame
Week 18
Title
Change from baseline in the caregivers's anxiety symptoms
Description
Beck Anxiety Inventory
Time Frame
Week 9
Title
Change from baseline in the caregivers's anxiety symptoms
Description
Beck Anxiety Inventory
Time Frame
Week 18
Title
Change from baseline in the caregivers's quality of life
Description
Quality of Life Questionnaire - WHOQOL
Time Frame
Week 9
Title
Change from baseline in the caregivers's quality of life
Description
Quality of Life Questionnaire - WHOQOL
Time Frame
Week 18
Title
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Description
Neuropsychiatric Inventory - NPI
Time Frame
Week 9
Title
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
Description
Neuropsychiatric Inventory - NPI
Time Frame
Week 18
Title
Change from baseline in the patient functionality
Description
Pfeffer Functional Activities Questionnaire
Time Frame
Week 9
Title
Change from baseline in the patient functionality
Description
Pfeffer Functional Activities Questionnaire
Time Frame
Week 18
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female caregivers
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Artur S Schuh, PhD
Phone
33598520
Email
schuh.afs@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andressa H Hermes-Pereira, CP
Phone
33598520
Email
andressahpereira@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Artur S Schuh, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andressa H Pereira, CP
Phone
5551997957558
Email
andressahpereira@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of a Psychoeducation and Support Protocol by Phone in the Aid of Caregivers of Patients With Dementia.
We'll reach out to this number within 24 hrs