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Trial registered on ANZCTR


Registration number
ACTRN12614000976684
Ethics application status
Approved
Date submitted
29/08/2014
Date registered
11/09/2014
Date last updated
8/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive training on people with dementia - a randomized controlled trial
Scientific title
Cognitive training on people with dementia in day care compared with normal day care on participants' cognition, health-related quality of life, physical functioning and use of health and social services
Secondary ID [1] 285216 0
None
Universal Trial Number (UTN)
Trial acronym
FINCOG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 292836 0
Condition category
Condition code
Neurological 293137 293137 0 0
Dementias
Neurological 293138 293138 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive training.
Cognitive training intervention uses tasks mainly focusing on executive functioning (cognitive flexibility, planning, speed of processing, reasoning and attention) thus stimulating presumably more frontal areas of the brain. The cognitive training program will be a clinically and neuropsychologically relevant modification of the cognitive remediation therapy (CRT) , which is a training based intervention aimed to improve cognitive processes on psychiatric patients (Wykes et al 1999). The tasks will be tailored according to the participants' level of cognitive abilities, interests and adherence. The cognitive training takes place twice a week in Helsinki day centres in groups of 1-5 participants. Participants perform predetermined paper and pencil tasks for 45-60 min/day. Their work is directed, supported and assessed by a day centre trained assistant who will be trained by a neuropsychologist. Participants will be transferred to day centres by taxis and they will be provided also the normal day centre program. The whole day care will take approximately 4-6 hours and it includes also socializing with other participants. The intervention lasts 12 weeks.
Intervention code [1] 290091 0
Treatment: Other
Comparator / control treatment
Control group will receive the normal day care program including transportation, socializing, attention and meals.
Control group
Active

Outcomes
Primary outcome [1] 292999 0
Global cognition according to ADAS-Cog
Timepoint [1] 292999 0
At 3 months and 9 months after randomization
Primary outcome [2] 293000 0
Health related quality of life according to 15D
Timepoint [2] 293000 0
At 3 months and 9 months after randomization
Secondary outcome [1] 310106 0
Daily functioning according to ADCS-ADL
Timepoint [1] 310106 0
At 3 months and 9 months after randomization
Secondary outcome [2] 310107 0
Subtests of Wechsler Adult Intelligence Scale IV: (similarities, block design, digit span, digit symbol)
Timepoint [2] 310107 0
At 3 and 9 months after randomization
Secondary outcome [3] 310108 0
Planning according to Clock-Drawing test
Timepoint [3] 310108 0
At 3 and 9 months after randomization
Secondary outcome [4] 310109 0
language capabilities according to Verbal fluency-test
Timepoint [4] 310109 0
At 3 and 9 months after randomization
Secondary outcome [5] 310110 0
Psychological well-being according to PWB
Timepoint [5] 310110 0
at 3 and 9 months after randomization
Secondary outcome [6] 310111 0
Attention according to FAB, Trail making A, Stroop test (shortened version)
Timepoint [6] 310111 0
3 and 9 months after randomization
Secondary outcome [7] 310112 0
alertness according to CIBIC-Plus
Timepoint [7] 310112 0
3 and 9 months after randomization
Secondary outcome [8] 310113 0
Use and costs of health and social services will be gathered from hospital and social service documentations as well as medical records and death dates from the central registers
Timepoint [8] 310113 0
From baseline (randomization) to 24 months.
Secondary outcome [9] 310114 0
In a substudy 20 intervention + 20 patients with mild to moderate dementia (preferably Alzheimer disease) will undergo functional MRI at Aalto university Advanced Magnetic Imaging Centre (AMI) by 3T MRI (Magnetom Skyra, Siemens). We will use a visual n-back task during the fMRI with three load levels (0-back, 1-back and 2-back) in order to clarify the areas and intensity of patients’ brain areas involved with these tasks requiring attention and working memory. In the n-back task, memory load is increased in a parametric manner. At all memory load levels, the number of stimuli, and the number and type of responses remain the same. The memory load is modulated by changing the instruction given to the subject. The presentation of the stimuli is controlled by Presentation software (Neurobehavioral Systems, Inc.) which also collects information concerning responses (correct, incorrect, misses) and reaction times. The findings of intervention and control participants will be described and compared.
Timepoint [9] 310114 0
Baseline and post-intervention (3months) will be compared
Secondary outcome [10] 310354 0
Primary caregiver's health related quality of life according to RAND-36
Timepoint [10] 310354 0
at 3 and 9 months after randomization
Secondary outcome [11] 310355 0
Primary caregiver's psychological well-being according to PWB
Timepoint [11] 310355 0
at 3 and 9 months after randomization

Eligibility
Key inclusion criteria
Dementia accoding to Clinical dementia rating (mild to moderate: 0.5 to 3).
Participating day center activities 2x /wk in Helsinki day care center.
Volunteer. Finnish speaking, not at terminal stage, ability to see, hear, read and write, and living at home. If at moderate or severe stage, caregiver's consent is required.
In substudy to fMRI: Alzheimer diagnosis (undergone detailed diagnostics for AD), mild to moderate dementia (CDR 0.5 to 2);
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No dementia, not participating in day center twice/wk; other native language but Finnish, not able to see or hear, read or write sufficiently to participate cognitive training.
Exclusion criteria for fMRI substudy: Key exclusion criteria in fMRI:
Subjects with any kind of metal fragments in the body should not have an MR scan without further safety controls. This includes e.g. any electronic, magnetic or mechanical implants (such as a cardiac pacemaker, infusion pumps or cochlear implants), aneurysm clips in the brain or other surgical clips, or prostheses (such as artificial heart valves or dentures).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After the baseline visit, those patient fulfilling inclusion criteria will be randomized either to intervention or control group using computer-generated randomly allocated numbers received by telephone from a randomization centre. We use block randomization in which patients from one day center will be randomized in blocks of mild, moderate or severe stage of dementia separately.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized in order they have been assessed at baseline visit. The randomization will be performed using computer-generated randomly allocated numbers received by telephone from a randomization centre. A person not related to patient assessments calls to a person (neither related to patient assessments) at a randomization centre who is not aware the identities of potential participants. The person calling read the names from a paper list in the order which they had been assessed. Every randomization result will appear in the program after the participants name has been written and the person executing the randomization has confirmed the process with initials. This assures that neither the person calling, nor person doing the randomization cannot influence the result.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size was calculated based on the primary outcome measure ADAS-Cog. To ensure 80% power to detect a four point difference with standard deviation about nine (Jones et al. 2004) between the treatment and control groups at two-sided alfa=0.05, 79 participants are needed in each arm. The final sample size will be decided depending on the feasibility of intervention and drop-out rate. We aim to include at least 20 +20 participants into fMRI tests. 20 + 20 should be sufficient to show differences between those training and controls in fMRI but the recruited groups may be more heterogeneous in their AD than expected, there may be problems in compliance during the fMRI. To ensure sufficient sample size we might recruit 30+30.
All patients assessed at baseline and at 3 months will be included in the data analyses of the changes in cognitive functioning (intention-to-treat). The data will be presented as means with standard deviations, or numbers with percentages. 95% confidence intervals (CI) are given for the most important outcomes. Statistical comparison between the groups will be performed using t-test, Mann-Whitney U-test, or the Chi-Square test when appropriate. Repeated measures are analyzed using mixed-effect models with the appropriate contrast. All participants will be included in the use and costs of services analyses. As the data for costs will be highly skewed, bias-corrected and accelerated bootstrap estimation will be used to derive 95% CIs. Differences between the means will be tested by analysis of covariance (ANCOVA) with appropriate contrast.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6306 0
Finland
State/province [1] 6306 0

Funding & Sponsors
Funding source category [1] 289831 0
Hospital
Name [1] 289831 0
Helsinki University Central Hospital EVO funding
Address [1] 289831 0
HUS- Yhtymahallinto
PO Box 20
FIN-00029 HUS
Finland
Country [1] 289831 0
Finland
Primary sponsor type
Individual
Name
Kaisu Pitkala
Address
HUS- Unit of Primary Health Care
and University of Helsinki, Department of General Practice
PO Box 20
FIN-00014 University of Helsinki
Finland
Country
Finland
Secondary sponsor category [1] 288521 0
None
Name [1] 288521 0
Address [1] 288521 0
Country [1] 288521 0
Other collaborator category [1] 278131 0
Individual
Name [1] 278131 0
Marja Hietanen, PhD ( Head of the Unit of Neuropsychology)
(developer of cognitive training programme)
Address [1] 278131 0
Helsinki University Central Hospital
Department of Neurology
PO BOx 302
FIN-00029 HUS
Finland
Country [1] 278131 0
Finland
Other collaborator category [2] 278132 0
Individual
Name [2] 278132 0
Synnove Carlson, MD, PhD, prof (fMRI researcher)
Address [2] 278132 0
O.V. Lounasmaa Laboratory
AMI Centre
Aalto University School of Science
P.O Box 13000
FI-00076 AALTO
Finland
Country [2] 278132 0
Finland
Other collaborator category [3] 278133 0
Individual
Name [3] 278133 0
Helena Soini, DSc (Helsinki Day care coordinator)
Address [3] 278133 0
Social Services and Health Care Department
PO Box 6009
FI 00099
City of Helsinki
Country [3] 278133 0
Finland
Other collaborator category [4] 278134 0
Individual
Name [4] 278134 0
Hannu Kautiainen, PhD, biostatistician
Address [4] 278134 0
Helsinki University Central Hospital, Unit of Primary Health Care and University of Helsinki, Department of General Practise
PO BOX 20
FIN-00014 University of Helsinki
Finland
Country [4] 278134 0
Finland
Other collaborator category [5] 278135 0
Individual
Name [5] 278135 0
Timo Strandberg, MD, PhD, prof
Address [5] 278135 0
University of Helsinki
Department of Medicine,
University of Helsinki,
PO Box 22,
FIN-00014 Helsingin yliopisto
FINLAND
Country [5] 278135 0
Finland
Other collaborator category [6] 278148 0
Individual
Name [6] 278148 0
Eeva-Liisa Kallio, Lic Phil, (PhD student)
Address [6] 278148 0
Helsinki University Central hospital
Department of Neurology
PO BOx 302
FIN-00029 HUS
Finland
Country [6] 278148 0
Finland
Other collaborator category [7] 278149 0
Individual
Name [7] 278149 0
Hanna Ohman, MD (PhD student)
Address [7] 278149 0
Laakso Hospital
Laakarinkatu 8
PL 6600
00099 City of Helsinki
Finland
Country [7] 278149 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291563 0
Helsinki University Central Hospital, Ethics Committee, Department of Medicine
Ethics committee address [1] 291563 0
Biomedicum Helsinki 2 C, Tukholmankatu 8 C, PL 705, 00029 HUS
Ethics committee country [1] 291563 0
Finland
Date submitted for ethics approval [1] 291563 0
Approval date [1] 291563 0
30/04/2014
Ethics approval number [1] 291563 0

Summary
Brief summary
Recent advances in neuropathology of cognitive reserves provide hypotheses on effects of cognitive training among patients with dementia. Executive functioning may be affected in later stages of dementia after prefrontal areas of brain becoma affected. Executive functions are the brain functions needed to manage our daily functioning, our emotions and our behavior in pursuit of our goals. Efficient executive functioning might compensate other cognitive disorders, e.g. memory decline. Thus, rehearsing dementia patients' executive functioning may improve daily functioning and lead to compensation of impaired cognitive domains.
The aim this study is to investigate the efficacy of cognitive training (CoTr) focusing on executive functioning among community-dwelling patients with mild to severe dementia with a 24 months follow-up. The aim of this large RCT is to clarify the effects of CoTr on their global cognition, various domains of executive functioning and cognition, participants' daily functioning, HrQOL and use of health and social services.
In a parallel substudy with RCT design we aim to explore in detail the effects of CoTr among mild to moderate AD patients in fMRI.
Trial website
Trial related presentations / publications
Kallio EL, Hietanen M, Kautiainen H, Öhman H, Pitkala KH. Cognitive training in dementia.
Systematic review. J Alz Dis 2017;56(4):1349-1372
Kallio EL, Pitkala KH. Feasibility and baseline findings of a cognitive training intervention in
a randomised controlled trial among community-dwelling elderly persons with
dementia. Eur Geriatr Med 2017;11:245-9.
Kallio EL; Öhman H, Kautiainen H, Soini H, Hietanen M, Pitkala KH. Effectiveness of
cognitive training on global cognition and HRQoL. A randomized, controlled trial.
J Am Geriatr Soc 2018 Apr;66(4):664-670.
Public notes

Contacts
Principal investigator
Name 50894 0
Prof Kaisu Pitkala
Address 50894 0
University of Helsinki
Department of General Practice and Primary Health Care
PO Box 20
00014 University of Helsinki
Country 50894 0
Finland
Phone 50894 0
358503385546
Fax 50894 0
Email 50894 0
kaisu.pitkala@helsinki.fi
Contact person for public queries
Name 50895 0
Prof Kaisu Pitkala
Address 50895 0
University of Helsinki
Department of General Practice and Primary Health Care
PO Box 20
00014 University of Helsinki
Country 50895 0
Finland
Phone 50895 0
+358 50 3385546
Fax 50895 0
Email 50895 0
kaisu.pitkala@helsinki.fi
Contact person for scientific queries
Name 50896 0
Prof Kaisu Pitkala
Address 50896 0
University of Helsinki
Department of General Practice and Primary Health Care
PO Box 20
00014 University of Helsinki
Country 50896 0
Finland
Phone 50896 0
+358503385546
Fax 50896 0
Email 50896 0
kaisu.pitkala@helsinki.fi

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary