Early Counseling and Support for Alzheimer's Disease Caregivers

Summary

This randomized trial evaluates the efficacy of counselling for reducing anxiety and depression in caregivers of patients with dementia. Half of the participants will receive six hours providing counselling and psycho-social support to caregivers along with a specific telephone support service - Ad Hoc Telephone Counselling whereas the remaining participants will receive six hours providing general information about Alzheimer Disease.

Conditions

• Alzheimer's Disease

Interventions

BEHAVIORAL

Psychosocial Intervention

The caregiver in the intervention arm will meet the counselors six times. The first and the last sessions will be attended by the caregiver only whereas the remaining four sessions will be attended by the caregiver and other family members. Interventions will be tailored for the caregivers based upon: 1) depression and anxiety; 2) burden; 3) self care and health-related behavior; 4) social support; and 5) behavioral symptoms. The design and management of the structured intervention will follow a published counseling caregiver manual, based on the experiences matured at New York University. Every session will be documented.

BEHAVIORAL

Educational Intervention on AD

The caregiver enrolled in this arm:1) will not receive counseling or support; 2) will participate to group sessions; 3) the six hours sessions will divulge information on AD using a slide-show. Each session will focus on the following topic: (a) diagnosis and treatment b) cognitive deficit management, c) behavioral disturbance management, d) daily living management, e) non-pharmacological treatment, f) legal issues and available health and social services. Additionally, contrary to other arm, caregivers will not receive any telephone calls after the end of the educational sessions.

Sponsors & Collaborators

• Azienda Ospedaliera di Perugia

  collaborator OTHER

• Azienda Ospedaliera di Terni

  collaborator UNKNOWN

• Azienda Unità Sanitaria Locale Umbria n. 2

  collaborator UNKNOWN

• Azienda Sanitaria Locale N.1 dell'Umbria

  lead OTHER

Principal Investigators

• Alessandro Montedori, MD · Regional Health Authority of Umbria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2017-01-31

Completion

2017-12-31

Countries

• Italy

Study Locations