CClinicalTrials.gg
Status unknownNCT03260608Updated Jan 14, 2020

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

An interventional study of Telesupport in Dementia, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Dementia

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Keywords

  • dementia, deficits, burden, caregivers, telemedicine.
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Telesupport

  • No intervention
    Control

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

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.

05

What researchers measure

Primary outcomes

  1. Change from baseline in the caregiver's level of burden

    Zarit Burden Interview

    Time frame: Week 9

  2. Change from baseline in the caregiver's level of burden

    Zarit Burden Interview

    Time frame: Week 18

Secondary outcomes

  1. Change from baseline in the caregivers's depressive symptoms

    Beck Depression Inventory

    Time frame: Week 9

  2. Change from baseline in the caregivers's depressive symptoms

    Beck Depression Inventory

    Time frame: Week 18

  3. Change from baseline in the caregivers's anxiety symptoms

    Beck Anxiety Inventory

    Time frame: Week 9

  4. Change from baseline in the caregivers's anxiety symptoms

    Beck Anxiety Inventory

    Time frame: Week 18

  5. Change from baseline in the caregivers's quality of life

    Quality of Life Questionnaire - WHOQOL

    Time frame: Week 9

  6. Change from baseline in the caregivers's quality of life

    Quality of Life Questionnaire - WHOQOL

    Time frame: Week 18

  7. Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient

    Neuropsychiatric Inventory - NPI

    Time frame: Week 9

  8. Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient

    Neuropsychiatric Inventory - NPI

    Time frame: Week 18

  9. Change from baseline in the patient functionality

    Pfeffer Functional Activities Questionnaire

    Time frame: Week 9

  10. Change from baseline in the patient functionality

    Pfeffer Functional Activities Questionnaire

    Time frame: Week 18

06

Study locations

1 of 1 sites recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, 90035903, Brazil
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03260608
Lead sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Jan 15, 2017
Primary completion
Apr 15, 2020 (estimated)
Completion
Jun 20, 2020 (estimated)
Last update
Jan 14, 2020

Study contacts

Artur S Schuh, PhD
Contact
schuh.afs@gmail.com
33598520
Andressa H Hermes-Pereira, CP
Contact
andressahpereira@gmail.com
33598520
Artur S Schuh, PhD
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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