Comprehensive Cognitive Remediation as a Strategy to Prevent Cognitive Impairment Associated With Age and Disability With the REHACOP Program
NCT03435029, Not applicable, Completed, University of Deusto
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comprehensive Cognitive Remediation as a Strategy to Prevent Cognitive Impairment Associated With Age and Disability With the REHACOP Program | ClinicalTrials.gov |
| NCT number | NCT03435029 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 140 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Deusto | ClinicalTrials.gov |
| Conditions | Aging | ClinicalTrials.gov |
| Interventions | Cognitive Remediation Program (REHACOP), Occupational Therapy | ClinicalTrials.gov |
| First posted | 2018-02-15 | ClinicalTrials.gov |
| Last updated | 2019-07-18 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline to post-treatment and follow-up on one final neurocognition composite score after receiving cognitive remediation. | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline score to post-treatment and follow-up on Geriatric Depression Scale (GDS) | 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). | ClinicalTrials.gov |
| Secondary | Change from baseline score to post-treatment and follow-up on Neuropsychiatric Inventory Questionnaire (NPI-Q) | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline score to post-treatment and follow-up on Lille Apathy Rating Scale (LARS) | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline score to post-treatment and follow-up on Multidimensional Fatigue Inventory (MFI) | 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). | ClinicalTrials.gov |
| Secondary | Change from baseline score to post-treatment and follow-up on Satisfaction With Life Scale (SWLS) | 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) | ClinicalTrials.gov |
| Secondary | Change from baseline score to post-treatment and follow-up on Subjective Questionnaire on Cognitive and Functional Difficulties of the patient and caregivers | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 31735487 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)