Indication for Modification of Patient Cognitive StatusNCT03944135

Cognitive Rehabilitation in Older Adults With Neuron-up (CROAN)

A study testing Web platform: Neuronup in people with Indication for Modification of Patient Cognitive Status, run by Universidad de Burgos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Introduction. The application of new technologies for cognitive rehabilitation has increased over the last years and has enabled occupational therapists to work more efficiently, minimizing costs and time for analysis, management, and design of activities. Objective. Read more about this study

Who is it for?: Ages 75 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Indication for Modification of Patient Cognitive Status
What is being tested?: Web platform: Neuronup
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSpain
Study dates: 15 Feb 2019to 20 Feb 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 to 85 years
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

subjects between 75 and 85 years of age;
obtain a score greater than 20 points for the MEC (Lobo's cognitive mini-exam); and
attend occupational therapy sessions on a regular basis.

Who cannot join

presence of neurocognitive disorder (Alzheimer's-type dementia among others);
not be an institutionalized resident at a nursing home;
a family history of a psychiatric problem;
presence of polipathology; and
have lived at a nursing home for less than 2 months.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Olalla Saiz Vazquez
Burgos, 09003

Other trials in Spain

About this study

Official title: Effectiveness of Two Predefined Groups With Cognitive Rehabilitation in Older Adults With the Program Neuron-up

Objective. The purpose of the present study was to assess the effect of cognitive intervention using the web platform Neuronup in a group of elderly subjects; the study is based on the dependent variables (memory, attention, and language) analyzed with the abbreviated Barcelona Test.

Subjects and Methods. Aquasi-experimental design was carried out with subjects assigned to two groups: a control group (20 subjects) and an experimental group (20 subjects). The abbreviated Barcelona Test was administered to assess patients before and after the intervention with this software to draw conclusions.

Read the detailed description

Results. Analyses of variance (ANOVA), analyses of covariance (ANCOVA), and multivariate analyses of variance (MANOVA) were perfomed in the memory, orientation, reading, and language domains. Statistically signifcant differences were recorded in all domains except language where scores remained the same.

Conclusion. It has been demonstrated that Neuronup is an effective program for improving cognitive processes such as memory, attention, and orientation in older adults, hence it would be beneficial to implement technology-based treatments conducted by specialized professionals.

Conditions: Indication for Modification of Patient Cognitive Status
Being tested: Web platform: Neuronup
Keywords: Cognition, Cognitive Dissonance, Geriatrics, Technology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Web platform: NeuronupOther
Neuronup is a web platform designed for neuropsychological rehabilitation that is focused on functional cognitive impairments resulting from normal aging and other causes. Neuronup emerged as a scientific, viable and accessible technological initiative.

Study groups in NCT03944135
Study group	Role	What they receive
Experimental group	Experimental	The sample consisted of 40 people: 20 in an experimental group. There were 5 men and 15 women. Receives: Other: Web platform: Neuronup
Control group	Active comparator	The sample consisted of 40 people: 20 in a control group. There were 5 men and 15 women. Receives: Other: Web platform: Neuronup

What is being measured

The primary outcome is the main question the study is designed to answer.

Reading is assessed in two pre defined groups of individuals
The abbreviated Barcelona Test is used to assess cognitive reading function in which the results highlight the existence of statistically significant differences in the difference scores reading.
The test consists of 41 subtests that generate 55 variables which assess the following cognitive functions: language, orientation, forward/backward digit span, automatized sequences and mental control, repetition, confrontation naming, semantic fluency (animals), verbal comprehension, reading, writing, praxis (ideomotor, melokinetic, and constructional), visual perceptual functions, verbal memory (story), visual memory, arithmetic problems, similarities, digit-symbol and block design. The cognitive profile and global scale score were obtained from all scores.
Measured: 3 months
Memory is assessed in two pre defined groups of individuals
The abbreviated Barcelona Test is used to assess cognitive memory function in which the results highlight the existence of statistically significant differences in the difference scores memory.
The test consists of 41 subtests that generate 55 variables which assess the following cognitive functions: language, orientation, forward/backward digit span, automatized sequences and mental control, repetition, confrontation naming, semantic fluency (animals), verbal comprehension, reading, writing, praxis (ideomotor, melokinetic, and constructional), visual perceptual functions, verbal memory (story), visual memory, arithmetic problems, similarities, digit-symbol and block design. The cognitive profile and global scale score were obtained from all scores.
Measured: 3 months
Orientation is assessed in two pre defined groups of individuals
The abbreviated Barcelona Test is used to assess cognitive orientation function in which the results highlight the existence of statistically significant differences in the difference scores orientation.
The test consists of 41 subtests that generate 55 variables which assess the following cognitive functions: language, orientation, forward/backward digit span, automatized sequences and mental control, repetition, confrontation naming, semantic fluency (animals), verbal comprehension, reading, writing, praxis (ideomotor, melokinetic, and constructional), visual perceptual functions, verbal memory (story), visual memory, arithmetic problems, similarities, digit-symbol and block design. The cognitive profile and global scale score were obtained from all scores.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201920 Feb 2019

First posted9 May 2019
Study start15 Feb 2019
Primary completion20 Feb 2019
Study completion20 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Indication for Modification of Patient Cognitive StatusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This is a quasi-experimental design with non-equivalent groups (pretest-posttest) carried out in a more realistic setting, where the dependent variables of interest were manipulated by the researcher under controlled conditions.
Masking: Single blind
Who is masked: Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03944135
Sponsor's protocol ID: UBurgos
Other IDs: IR 10/2019
Status last verified: May 2019
First submitted: 11 Mar 2019
Last updated: 9 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mohs RC, Ashman TA, Jantzen K, Albert M, Brandt J, Gordon B, Rasmusson X, Grossman M, Jacobs D, Stern Y. A study of the efficacy of a comprehensive memory enhancement program in healthy elderly persons. Psychiatry Res. 1998 Feb 27;77(3):183-95. doi: 10.1016/s0165-1781(98)00003-1.
PubMed 9707301
Dellefield KS, McDougall GJ. Increasing metamemory in older adults. Nurs Res. 1996 Sep-Oct;45(5):284-90. doi: 10.1097/00006199-199609000-00006.
PubMed 8831655
Wilkinson AJ, Yang L. Long-Term Maintenance of Inhibition Training Effects in Older Adults: 1- and 3-Year Follow-Up. J Gerontol B Psychol Sci Soc Sci. 2016 Jul;71(4):622-9. doi: 10.1093/geronb/gbu179. Epub 2015 Jan 7.
PubMed 25573153
Neely AS, Backman L. Effects of multifactorial memory training in old age: generalizability across tasks and individuals. J Gerontol B Psychol Sci Soc Sci. 1995 May;50(3):P134-40. doi: 10.1093/geronb/50b.3.p134.
PubMed 7767691
Lachman ME, Weaver SL, Bandura M, Elliott E, Lewkowicz CJ. Improving memory and control beliefs through cognitive restructuring and self-generated strategies. J Gerontol. 1992 Sep;47(5):P293-9. doi: 10.1093/geronj/47.5.p293.
PubMed 1512434
Valentijn SA, van Hooren SA, Bosma H, Touw DM, Jolles J, van Boxtel MP, Ponds RW. The effect of two types of memory training on subjective and objective memory performance in healthy individuals aged 55 years and older: a randomized controlled trial. Patient Educ Couns. 2005 Apr;57(1):106-14. doi: 10.1016/j.pec.2004.05.002.
PubMed 15797159
Floyd M, Scogin F. Effects of memory training on the subjective memory functioning and mental health of older adults: a meta-analysis. Psychol Aging. 1997 Mar;12(1):150-61. doi: 10.1037//0882-7974.12.1.150.
PubMed 9100276
Valencia C, Lopez-Alzate E, Tirado V, Zea-Herrera MD, Lopera F, Rupprecht R, Oswald WD. [Cognitive effects of combined memory and psychomotor training in elderly adults]. Rev Neurol. 2008 Apr 16-30;46(8):465-71. Spanish.
PubMed 18428103
E Mintzer J, F Mirski D, S Hoernig K. Behavioral and psychological signs and symptoms of dementia: a practicing psychiatrist's viewpoint. Dialogues Clin Neurosci. 2000 Jun;2(2):139-55. doi: 10.31887/DCNS.2000.2.2/jmintzer.
PubMed 22034243
Valdizan JR. [Cognitive functions and neuronal networks in the social brain]. Rev Neurol. 2008;46 Suppl 1:S65-8. Spanish.
PubMed 18302126
Rey Cao A, Canales Lacruz I, Taboas Pais MI. [Quality of life perceived by the elderly. Results of the "Memory in movement" program which provide cognitive stimulation using motricity]. Rev Esp Geriatr Gerontol. 2011 Mar-Apr;46(2):74-80. doi: 10.1016/j.regg.2010.08.005. Epub 2011 Mar 25. Spanish.
PubMed 21440332
Wenisch E, Cantegreil-Kallen I, De Rotrou J, Garrigue P, Moulin F, Batouche F, Richard A, De Sant'Anna M, Rigaud AS. Cognitive stimulation intervention for elders with mild cognitive impairment compared with normal aged subjects: preliminary results. Aging Clin Exp Res. 2007 Aug;19(4):316-22. doi: 10.1007/BF03324708.
PubMed 17726363
Jean L, Bergeron ME, Thivierge S, Simard M. Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature. Am J Geriatr Psychiatry. 2010 Apr;18(4):281-96. doi: 10.1097/JGP.0b013e3181c37ce9.
PubMed 20220584
Novoa AM, Juarez O, Nebot M. [Review of the effectiveness of cognitive interventions in preventing cognitive deterioration in healthy elderly individuals]. Gac Sanit. 2008 Sep-Oct;22(5):474-82. doi: 10.1157/13126930. Spanish.
PubMed 19000530

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Two Predefined Groups With Cognitive Rehabilitation in Older Adults With the Program Neuron-up
ClinicalTrials.gov ID: NCT03944135
Acronym / sponsor ID: UBurgos
Conditions: Indication for Modification of Patient Cognitive Status
Keywords: Cognition, Cognitive Dissonance, Geriatrics, Technology
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Universidad de BurgosUniversity, hospital or other
Study start: 15 Feb 2019 (actual)
Primary completion: 20 Feb 2019 (actual)
Study completion: 20 Feb 2019 (actual)
First posted: 9 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: This is a quasi-experimental design with non-equivalent groups (pretest-posttest) carried out in a more realistic setting, where the dependent variables of interest were manipulated by the researcher under controlled conditions.

Arm	Type	Receives
Experimental group	Experimental	Other: Web platform: NeuronupThe sample consisted of 40 people: 20 in an experimental group. There were 5 men and 15 women.
Control group	Active comparator	Other: Web platform: NeuronupThe sample consisted of 40 people: 20 in a control group. There were 5 men and 15 women.

Who may qualify

Ages: 75 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

subjects between 75 and 85 years of age;
obtain a score greater than 20 points for the MEC (Lobo's cognitive mini-exam); and
attend occupational therapy sessions on a regular basis.

Key exclusion criteria (5 listed)

presence of neurocognitive disorder (Alzheimer's-type dementia among others);
not be an institutionalized resident at a nursing home;
a family history of a psychiatric problem;
presence of polipathology; and
have lived at a nursing home for less than 2 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Web platform: NeuronupNeuronup is a web platform designed for neuropsychological rehabilitation that is focused on functional cognitive impairments resulting from normal aging and other causes. Neuronup emerged as a scientific, viable and accessible technological initiative.	Other	Control group, Experimental group

Primary outcome

Reading is assessed in two pre defined groups of individuals
Time frame: 3 months
The abbreviated Barcelona Test is used to assess cognitive reading function in which the results highlight the existence of statistically significant differences in the difference scores reading. The test consists of 41 subtests that generate 55 variables which assess the following cognitive functions: language, orientation, forward/backward digit span, automatized sequences and mental control, repetition, confrontation naming, semantic fluency (animals), verbal comprehension, reading, writing, praxis (ideomotor, melokinetic, and constructional), visual perceptual functions, verbal memory (story), visual memory, arithmetic problems, similarities, digit-symbol and block design. The cognitive profile and global scale score were obtained from all scores.
Memory is assessed in two pre defined groups of individuals
Time frame: 3 months
The abbreviated Barcelona Test is used to assess cognitive memory function in which the results highlight the existence of statistically significant differences in the difference scores memory. The test consists of 41 subtests that generate 55 variables which assess the following cognitive functions: language, orientation, forward/backward digit span, automatized sequences and mental control, repetition, confrontation naming, semantic fluency (animals), verbal comprehension, reading, writing, praxis (ideomotor, melokinetic, and constructional), visual perceptual functions, verbal memory (story), visual memory, arithmetic problems, similarities, digit-symbol and block design. The cognitive profile and global scale score were obtained from all scores.
Orientation is assessed in two pre defined groups of individuals
Time frame: 3 months
The abbreviated Barcelona Test is used to assess cognitive orientation function in which the results highlight the existence of statistically significant differences in the difference scores orientation. The test consists of 41 subtests that generate 55 variables which assess the following cognitive functions: language, orientation, forward/backward digit span, automatized sequences and mental control, repetition, confrontation naming, semantic fluency (animals), verbal comprehension, reading, writing, praxis (ideomotor, melokinetic, and constructional), visual perceptual functions, verbal memory (story), visual memory, arithmetic problems, similarities, digit-symbol and block design. The cognitive profile and global scale score were obtained from all scores.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
Background: PubMed 9707301Mohs RC, Ashman TA, Jantzen K, Albert M, Brandt J, Gordon B, Rasmusson X, Grossman M, Jacobs D, Stern Y. A study of the efficacy of a comprehensive memory enhancement program in healthy elderly persons. Psychiatry Res. 1998 Feb 27;77(3):183-95. doi: 10.1016/s0165-1781(98)00003-1.
Background: PubMed 8831655Dellefield KS, McDougall GJ. Increasing metamemory in older adults. Nurs Res. 1996 Sep-Oct;45(5):284-90. doi: 10.1097/00006199-199609000-00006.
Background: PubMed 25573153Wilkinson AJ, Yang L. Long-Term Maintenance of Inhibition Training Effects in Older Adults: 1- and 3-Year Follow-Up. J Gerontol B Psychol Sci Soc Sci. 2016 Jul;71(4):622-9. doi: 10.1093/geronb/gbu179. Epub 2015 Jan 7.
Background: PubMed 7767691Neely AS, Backman L. Effects of multifactorial memory training in old age: generalizability across tasks and individuals. J Gerontol B Psychol Sci Soc Sci. 1995 May;50(3):P134-40. doi: 10.1093/geronb/50b.3.p134.
Background: PubMed 1512434Lachman ME, Weaver SL, Bandura M, Elliott E, Lewkowicz CJ. Improving memory and control beliefs through cognitive restructuring and self-generated strategies. J Gerontol. 1992 Sep;47(5):P293-9. doi: 10.1093/geronj/47.5.p293.
Background: PubMed 15797159Valentijn SA, van Hooren SA, Bosma H, Touw DM, Jolles J, van Boxtel MP, Ponds RW. The effect of two types of memory training on subjective and objective memory performance in healthy individuals aged 55 years and older: a randomized controlled trial. Patient Educ Couns. 2005 Apr;57(1):106-14. doi: 10.1016/j.pec.2004.05.002.
Background: PubMed 9100276Floyd M, Scogin F. Effects of memory training on the subjective memory functioning and mental health of older adults: a meta-analysis. Psychol Aging. 1997 Mar;12(1):150-61. doi: 10.1037//0882-7974.12.1.150.
Background: PubMed 18428103Valencia C, Lopez-Alzate E, Tirado V, Zea-Herrera MD, Lopera F, Rupprecht R, Oswald WD. [Cognitive effects of combined memory and psychomotor training in elderly adults]. Rev Neurol. 2008 Apr 16-30;46(8):465-71. Spanish.
Background: PubMed 22034243E Mintzer J, F Mirski D, S Hoernig K. Behavioral and psychological signs and symptoms of dementia: a practicing psychiatrist's viewpoint. Dialogues Clin Neurosci. 2000 Jun;2(2):139-55. doi: 10.31887/DCNS.2000.2.2/jmintzer.
Background: PubMed 18302126Valdizan JR. [Cognitive functions and neuronal networks in the social brain]. Rev Neurol. 2008;46 Suppl 1:S65-8. Spanish.
Results publication: PubMed 21440332Rey Cao A, Canales Lacruz I, Taboas Pais MI. [Quality of life perceived by the elderly. Results of the "Memory in movement" program which provide cognitive stimulation using motricity]. Rev Esp Geriatr Gerontol. 2011 Mar-Apr;46(2):74-80. doi: 10.1016/j.regg.2010.08.005. Epub 2011 Mar 25. Spanish.
Results publication: PubMed 17726363Wenisch E, Cantegreil-Kallen I, De Rotrou J, Garrigue P, Moulin F, Batouche F, Richard A, De Sant'Anna M, Rigaud AS. Cognitive stimulation intervention for elders with mild cognitive impairment compared with normal aged subjects: preliminary results. Aging Clin Exp Res. 2007 Aug;19(4):316-22. doi: 10.1007/BF03324708.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olalla Saiz Vazquez principal investigator

Universidad de Burgos

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Web platform: Neuronup in people with Indication for Modification of Patient Cognitive Status, run by Universidad de Burgos at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reading is assessed in two pre defined groups of individuals (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03944135, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.