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

NCT03260608 | Unknown

• 1 other identifier: 17-0326
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

dementia, deficits, burden, caregivers, telemedicine.

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the caregiver's level of burden

  Zarit Burden Interview

  Week 9

• Change from baseline in the caregiver's level of burden

  Zarit Burden Interview

  Week 18

Secondary Outcomes (10)

• Change from baseline in the caregivers's depressive symptoms

  Week 9

• Change from baseline in the caregivers's depressive symptoms

  Week 18

• Change from baseline in the caregivers's anxiety symptoms

  Week 9

• Change from baseline in the caregivers's anxiety symptoms

  Week 18

• Change from baseline in the caregivers's quality of life

  Week 9

Study Arms (2)

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.

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.

Interventions

Telesupport 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female caregivers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Artur S Schuh, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Artur S Schuh, PhD

CONTACT

33598520; schuh.afs@gmail.com

Andressa H Hermes-Pereira, CP

CONTACT

33598520; andressahpereira@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual who evaluates the outcome(s) of interest in this case the applicators of scales and questionnaires
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 24, 2017
• Study Start: January 15, 2017
• Primary Completion: April 15, 2020
• Study Completion: June 20, 2020
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

BR (1)