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. 2018 Feb 12;19(1):100.
doi: 10.1186/s13063-017-2371-z.

The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial

Martina Vanova  1   2 , Eider Irazoki  3   4 , J Antonio García-Casal  3 , Fernando Martínez-Abad  5 , Cristina Botella  6   7 , Kate R Shiells  8 , Manuel A Franco-Martín  9   4
Affiliations

The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial

Martina Vanova et al. Trials. .

Abstract

Background: Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms.

Methods: In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year.

Discussion: The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments.

Trial registration: Current Controlled Trials ISRCTN, ID: 15742788 . Registered on 12 June 2017.

Keywords: Alzheimer’s disease; Cognition; Cognitive intervention; Cognitive rehabilitation; Computer-based intervention; Dementia; MCI; Psychosocial intervention.

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Conflict of interest statement

Ethics approval and consent to participate

The protocol was submitted for ethical approval in May 2017 to the Zamora Provincial Hospital Ethics Committee. Ethical approval was obtained on 17 May 2017.

Consent for publication

Not applicable

Competing interests

We have read and understood BMC policy on declaration of interests and declare the following interests: MV and EI are paid members of INTRAS Foundation responsible for development and distribution of GRADIOR software. MV is a Marie Curie Early-Stage Researcher in the INDUCT project. MFM is a founder and director of INTRAS Foundation and a supervisor within the INDUCT project. JAGC is a former member of INTRAS Foundation and has no current competing interests. FMA and CB have no competing interests.

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Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure. Recommended items to address in a clinical trial protocol and related documents
See this image and copyright information in PMC

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