TY - JOUR
A1 - Amici, Serena
A1 - Iannizzi, Pamela
A1 - Di Pucchio, Alessandra
A1 - Abraha, Iosief
A1 - Montedori, Alessandro
A1 - Chattat, Rabih
A1 - Vanacore, Nicola
T1 - Can early counselling and support for Alzheimer's disease caregivers reduce burden? Study protocol for a multicenter randomized controlled trial
Y1 - 2016/7/1
JF - Clinical Trials in Degenerative Diseases
JO - Clin Trials Degener Dis
SP - 99
EP - 106
VL - 1
IS - 3
UR - https://www.clinicaltdd.com/article.asp?issn=2542-3975;year=2016;volume=1;issue=3;spage=99;epage=106;aulast=Amici
DO - 10.4103/2468-5658.191352
N2 - Background: The activity of "caregiving" for people affected with Alzheimer's disease (AD) is associated with an augmentation in health problems (anxiety, depression, stress, increased mortality), as well as in social and financial problems. Different methods of counselling, to reduce caregiver anxiety and depression, have been shown to be effective.
Methods/Design: This study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled superiority trial with two parallel groups. Two hundred and sixty-four caregivers of AD patients will be randomly allocated to the modified Mittelmann psychosocial intervention or an educational intervention. The treatment will consist of 6 hours of counselling and psychosocial support to caregivers, administered by psychologists, along with a specific telephone support service, whereas the active control treatment will be 6 hours of general information about AD. The primary endpoint is change in caregiver burden measured with the Zarit Burden Interview. Secondary endpoints comprise caregiver depression, anxiety and quality of life. All endpoints will be measured at baseline, 6, 12 and 24 months post treatment.
Discussion: The results of this trial will be helpful to supply the efficacy of early counselling and psychosocial support for AD caregivers and offer in-depth useful information for stakholders and policy makers to implement strategies for caregivers.
Trial registration: Clinical Trials.gov identifier: NCT02685787; registered on 6 February 2016.
Ethics: This trial has been approved by Umbria Ethical Review Committee, Italy and will be performed in accordance with the norms on Good Clinical Practice and the Helsinki Declaration.
Informed consent: Written informed consent will be obtained from the caregivers.
ER -