| STUDY PROTOCOL |
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| Year : 2016 | Volume
: 1
| Issue : 3 | Page : 99-106 |
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Can early counselling and support for Alzheimer's disease caregivers reduce burden? Study protocol for a multicenter randomized controlled trial
Serena Amici1, Pamela Iannizzi2, Alessandra Di Pucchio3, Iosief Abraha M.D. 4, Alessandro Montedori4, Rabih Chattat5, Nicola Vanacore3
1 Azienda Sanitaria Locale N.1 dell'Umbria, Perugia, Italy
2 Department of Medicine, University of Padua, Padua, Italy
3 National Centre for Epidemiology, Surveillance, and Health Promotion, National Institute of Health, Rome, Italy
4 Health Planning Service, Regional Health Authority of Umbria, Perugia, Italy
5 Department of Psychology, University of Bologna, Bologna, Italy
Correspondence Address:
Iosief Abraha
Health Planning Service, Regional Health Authority of Umbria, Perugia
Italy
 Source of Support: This study was supported by a grant from Italian Ministry of Health (GR-2009-1607340)-Call for grant applications RF 2009 (Bando RicercaFinalizzata 2009-Ministero della Salute)., Conflict of Interest: None  | Check |
DOI: 10.4103/2468-5658.191352
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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. |
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