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

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.

Study Overview

• Status: Unknown
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Telesupport

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.

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Porto Alegre, Brazil, 90035903
    • Recruiting
    • Hospital de Clinicas de Porto Alegre
    • Contact: Andressa H Pereira, CP; Phone Number: 5551997957558; Email: andressahpereira@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.
No Intervention: Control; No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the caregivers's depressive symptoms	Beck Depression Inventory	Week 9
Change from baseline in the caregivers's depressive symptoms	Beck Depression Inventory	Week 18
Change from baseline in the caregivers's anxiety symptoms	Beck Anxiety Inventory	Week 9
Change from baseline in the caregivers's anxiety symptoms	Beck Anxiety Inventory	Week 18
Change from baseline in the caregivers's quality of life	Quality of Life Questionnaire - WHOQOL	Week 9
Change from baseline in the caregivers's quality of life	Quality of Life Questionnaire - WHOQOL	Week 18
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient	Neuropsychiatric Inventory - NPI	Week 9
Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient	Neuropsychiatric Inventory - NPI	Week 18
Change from baseline in the patient functionality	Pfeffer Functional Activities Questionnaire	Week 9
Change from baseline in the patient functionality	Pfeffer Functional Activities Questionnaire	Week 18

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Artur S Schuh, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Anticipated): April 15, 2020
• Study Completion (Anticipated): June 20, 2020

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: dementia, deficits, burden, caregivers, telemedicine.
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 17-0326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No