Effectiveness of a Psychoeducation and Support Protocol by Phone in the Aid of Caregivers of Patients With Dementia.

NCT ID: NCT03260608

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2020-06-20

Brief Summary

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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

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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

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The individual who evaluates the outcome(s) of interest in this case the applicators of scales and questionnaires

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Telesupport

Intervention Type BEHAVIORAL

In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.

Control

No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telesupport

In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Artur S Schuh, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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Hospital de ClĂ­nicas de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Artur S Schuh, PhD

Role: CONTACT

Andressa H Hermes-Pereira, CP

Role: CONTACT

Facility Contacts

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Andressa H Pereira, CP

Role: primary

5551997957558

Other Identifiers

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17-0326

Identifier Type: -

Identifier Source: org_study_id

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