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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03260608
Enrollment
148
Registered
2017-08-24
Start date
2017-01-15
Completion date
2020-06-20
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

dementia, deficits, burden, caregivers, telemedicine.

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.

Interventions

BEHAVIORALTelesupport

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

Sponsors

Federal University of Rio Grande do Sul
CollaboratorOTHER
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in the caregiver's level of burdenWeek 9Zarit Burden Interview

Secondary

MeasureTime frameDescription
Change from baseline in the caregivers's depressive symptomsWeek 9Beck Depression Inventory
Change from baseline in the caregivers's anxiety symptomsWeek 9Beck Anxiety Inventory
Change from baseline in the caregivers's quality of lifeWeek 9Quality of Life Questionnaire - WHOQOL
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patientWeek 9Neuropsychiatric Inventory - NPI
Change from baseline in the patient functionalityWeek 9Pfeffer Functional Activities Questionnaire

Countries

Brazil

Contacts

Primary ContactArtur S Schuh, PhD
schuh.afs@gmail.com33598520
Backup ContactAndressa H Hermes-Pereira, CP
andressahpereira@gmail.com33598520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026