Evaluation of GRADIOR, a neuropsychological rehabilitation programme for people with mild dementia and mild cognitive impairment

• Register: ISRCTN
• Last refreshed on: 25 July 2023
• Main ID: ISRCTN15742788
• Date of registration: 12/06/2017
• Prospective Registration: Yes
• Primary sponsor: INTRAS Foundation
• Public title: Evaluation of GRADIOR, a neuropsychological rehabilitation programme for people with mild dementia and mild cognitive impairment
• Scientific title: Evaluation of GRADIOR, a neuropsychological rehabilitation programme for people with mild dementia and mild cognitive impairment - a multicentre single-blinded randomised controlled trial
• Date of first enrolment: 01/09/2017
• Target sample size: 400
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15742788
• Study type: Interventional
• Study design: Multicentre single-blind randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Manuel Franco-Martín

Key inclusion & exclusion criteria

Inclusion criteria: 1. Males and females aged over 60
2. Formal diagnosis of dementia (meeting the DSM IV/TR5 criteria, Clinical Dementia Rating between 1 and 2, Geriatric Depression Scale score lower than 5) or MCI (meeting the Petersen criteria, Clinical Dementia Rating less than 0.5, Geriatric Depression Scale score lower than 5)
3. Capability making decisions
4. Having a reference caregiver
5. Being able to read and write in Spanish language
Exclusion criteria: 1. Mayor physical illness or disability which could affect participation (hearing loss, blindness, etc)
2. Neurological illness (Huntington's disease, cerebro-vascular stroke, Parkinson's disease, dementia with Lewy body)
3. Psychiatric diagnosis (depression, psychosis, bipolar disorder)
4. History of substance dependence (alcoholism or alcohol related dementia)
5. Taking antipsychotic medication

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia, mild cognitive impairment
Mental and Behavioural Disorders

Intervention(s)

Eligible participants will undergo a preliminary baseline testing of all outcome measures. Subsequently, participants will be randomised in equal proportion between 4 groups receiving cognitive rehabilitation (GRADIOR programme), psychosocial stimulation (EhcoButler programme), cognitive rehabilitation combined with psychosocial stimulation (GRADIOR+EhcoButler), and a treatment as usual group. Participants will be randomised using a computer-generated random number sequence. The Epidat 4.1 program will be used to generate this sequence. The allocation will be carried out by an independent researcher who will be unaware of the characteristics of the study. Participants will be allocated to each group using simple randomisation. Simple randomisation will allocate every participant randomly in a group independently of their characteristics (age, sex, education, area etc).

GRADIOR
The programme consists of exercises divided into 7 cognitive modalities (attention, memory, orientation, perception, calculus, executive functions and reasoning). Every cognitive modality contains various submodalities (e.g. sustained auditive attention, short-term iconic memory etc.) and every submodality can have from 2 to 11 levels of difficulty. Altogether, GRADIOR contains 45 different types of exercises in which stimuli change after every session to avoid boredom and increase unpredictability and maximise novelty effect. Overall GRADIOR consists of more than 45,000 different stimuli.
In a standard treatment, the duration of every exercise is approximately 1 minute and the duration of each treatment session is around 30 minutes. Every participant finishes the 30-minute session with a particular number of finished exercises. The next treatment session starts and continues with unfinished exe

Primary Outcome(s)

Cognitive performance, measured using Spanish versions of the following tests at baseline, 4 months and 12 months:
1. Mini-Mental State Examination (MMSE)
2. Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
3. Clock Drawing Test (CDT)
4. WAIS III – Coding digit symbol
5. Calculus and Digit Span subtests
6. Rivermead pattern recognition test
7. Trail making test versions A and B (TMT)
8. Cambridge Cognitive Examination (CAMCog) – matrices subtest
9. Semantic and phonologic verbal fluency tests

Secondary Outcome(s)

Assessed at baseline, at 4 and 12 months of the treatment and at 16 and 24 months in the follow-up:
1. Quality of life, assessed by the EuroQol EQ5D-5L
2. Depression symptoms, assessed by the Geriatric Depression Scale (GDS)
3. Activities of daily living and demographic information, health and use of services, assessed by the InterRAI-HC
4. Experience with technology, assessed by the Everyday Technology Use Questionnaire (ETUQ)
5. Quality of relationship with carer, assessed by the Quality of carer-patient relationship (QCPR)

Carers participating in the trial complete the following measures at the same timepoints as above:
1. Caregiver burden, assessed by the Zarit test
2. Depression symptoms, assessed by the Beck Depression Inventory II (BDI-II)
3. Anxiety symptoms, assessed by the State-Trait Anxiety Inventory (STAI)

Secondary ID(s)

INT-GRA01

2017-001843-11

Source(s) of Monetary Support

INTRAS Foundation, INDUCT - Interdisciplinary Network for Dementia Using Current Technology

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Approved 30/08/2018, Ethics Committee for Drug Research, Zamora Health Area (Hospital Provincial, C/Hernan Cortes n°40-49021, Zamora, Spain; [phone]; [e-mail]), ref: 387-E.C

Results

• Results available: Yes
• Date Completed: 01/05/2020