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Comprehensive Cognitive Remediation as a Strategy to Prevent Cognitive Impairment Associated With Age and Disability With the REHACOP Program

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ClinicalTrials.gov Identifier: NCT03435029
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Deusto

Brief Summary:

The aim of the study was to analyze the effectiveness of a comprehensive cognitive remediation program (REHACOP) in the non demented elderly, obtaining improvements in cognition and functional skills. It was a longitudinal randomized controlled trial with three assessments: basal, post-treatment, and 12-month follow-up.

Recruitment and enrollment were conducted between September 2012 and November 2016. All participants underwent a clinical interview and an extensive neuropsychological battery. Patients were randomized in an experimental and a control group. The groups were formed by a maximum of eight participants run by an experienced therapist. The experimental group received cognitive remediation for 3 months, 3 times per week, 60 minutes per session. The control group consisted of occupational group activities (reading the newspaper, drawing, singing or doing crafts) with the same frequency as the experimental group. Post-treatment assessment was carried out within the first week after completing the intervention. Finally, longitudinal follow-up at 12 months with neuropsychological assessments will be performed.

Objective: To examine the efficacy of a comprehensive cognitive training program (REHACOP) to improve cognition, clinical symptoms and functional disability for the elderly.


Condition or disease Intervention/treatment Phase
Aging Behavioral: Cognitive Remediation Program (REHACOP) Other: Occupational Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comprehensive Cognitive Remediation as a Strategy to Prevent Cognitive Impairment Associated With Age and Disability in the Elderly With the REHACOP Program
Actual Study Start Date : September 2012
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: Cognitive Remediation Program (REHACOP)
The cognitive rehabilitation program (REHACOP) is a 5 month intervention that allows both individual and group intervention. For the purpose of this study, we included intervention in several domains: attention, language, memory, processing speed, and executive functioning for 3 months, 3 times per week, in 60 minute per session.
Behavioral: Cognitive Remediation Program (REHACOP)
The REHACOP group received cognitive remediation sessions 3 times per week for 3 months in 60 minute per session. The rehabilitation consisted of 39 sessions divided into: attention and concentration unit (sustained, selective, alternating, and divided attention) 4 weeks; learning and memory unit (verbal and visual memory and learning strategies) 3 weeks; language (verbal fluency, syntax, grammar, vocabulary, and comprehension) 3 weeks; and executive functioning (objectives planning and attainment, verbal reasoning, categorization, and conceptualization). In addition, processing speed was trained transversely during all the sessions.

Active Comparator: Occupational Therapy
The control group performed of occupational group activities (memory tasks, reading the newspaper, drawing, singing or doing crafts). These activities were accomplished in a group format and with the same frequency as the implementation of REHACOP in the experimental group.
Other: Occupational Therapy
The control group received occupational group activities (reading the newspaper, drawing, singing or doing crafts) with the same frequency and format as the experimental group.




Primary Outcome Measures :
  1. Change from baseline to post-treatment and follow-up on one final neurocognition composite score after receiving cognitive remediation. [ Time Frame: 3 months and 12 months follow-up ]
    The neurocognition composite score is one z score that was based on the following test: BTA total score, total score of the forward digits and backward digit of the WAIS-III, total number of words beginning with the letter "p" in 3-minute and total number of words for animals and supermarket categories in 1-minute of the CIFA, total score of learning and total score of long-term recall of the HVLT-R, total score of learning and long-term recall of the BVMT-R, total score of the free drawing of the CDT, total score of letters and total score of the cube analysis of the VOSP, time of the TMT-A, total score of the SPCT, and total score of the word-color trial of the Stroop Test. All raw scores were converted to z-scores. TMT-A score was adjusted so that higher scores indicated better performance. The z-scores were pooled into one composite score with the average of the primary measures mentioned above. Higher scores in this composite score indicated better performance.


Secondary Outcome Measures :
  1. Change from baseline score to post-treatment and follow-up on Geriatric Depression Scale (GDS) [ Time Frame: 3 months and 12 month follow-up ]
    Geriatric Depression Scale (GDS-15) includes 15 items. Higher scores indicate a higher degree of depression (range from 0 to 15 points).

  2. Change from baseline score to post-treatment and follow-up on Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: 3 months and 12 months follow-up ]
    Neuropsychiatric Inventory Questionnaire (NPI-Q) includes 10 neuropsychiatric (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria, apathy, disinhibition, irritability, and aberrant motor behavior) domains assessed in terms of severity and frequency in a range from 0 to 120 points. Higher scores indicate greater neuropsychiatric behaviors.

  3. Change from baseline score to post-treatment and follow-up on Lille Apathy Rating Scale (LARS) [ Time Frame: 3 months and 12 months follow-up ]
    Lille Apathy Rating Scale (LARS) is composed by 33 items, subdivided into 9 subscales (everyday productivity, interests, taking initiative, novelty seeking/motivation, emotional responses, concern, social life, and self-awareness). These subscales are summed into a total score with a possible range from -36 to 36 points. Lower scores indicate a higher degree of apathy.

  4. Change from baseline score to post-treatment and follow-up on Multidimensional Fatigue Inventory (MFI) [ Time Frame: 3 months and 12 months follow-up ]
    Multidimensional Fatigue Inventory (MFI) is composed by 20 items divided into 5 subscales (general index, physical fatigue, mental fatigue, lack of motivation, lack of activity). Higher scores indicate greater fatigue (range from 0 to 140 points).

  5. Change from baseline score to post-treatment and follow-up on Satisfaction With Life Scale (SWLS) [ Time Frame: 3 months and 12 months follow-up ]
    Satisfaction With Life Scale (SWLS). This scale is composed by 5 items. Higher scores indicate greater live satisfaction (range from 0 to 35 points)

  6. Change from baseline score to post-treatment and follow-up on Subjective Questionnaire on Cognitive and Functional Difficulties of the patient and caregivers [ Time Frame: 3 months and 12 months follow-up ]
    Subjective complains were assessed by Subjective Questionnaire on Cognitive and Functional Complains of the patient and caregivers. These questionnaires are composed by 40 items each one of them. Higher scores indicate greater subjective complains (range from 0 to 120 points).



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age over 55 years
  2. signing informed consent
  3. independence in daily living activities

Exclusion Criteria:

  1. history of neurological or psychiatric conditions, Neuropsychiatric Inventory Cummings > 4
  2. illiterate
  3. Mini Mental State Examination < 20
  4. severe physical constraints.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435029


Locations
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Spain
University of Deusto
Bilbao, Bizcay, Spain, 48007
Sponsors and Collaborators
University of Deusto
Investigators
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Principal Investigator: Natalia Ojeda del Pozo, PhD University of Deusto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Deusto
ClinicalTrials.gov Identifier: NCT03435029    
Other Study ID Numbers: NSMC-004-UD
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Deusto:
aging
cognitive rehabilitation
REHACOP
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders