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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG069252 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Federal University of Minas Gerais | OTHER |
| National Institute on Aging (NIA) | NIH |
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This study aims to discover whether acquiring basic-literacy in adulthood can improve episodic memory and brain structural and functional connectivity. In a collaborative project between Brazil and USA, the investigators will use a randomized controlled trial approach to leverage the level of evidence of the benefits of basic adult-education as a possible cognitive reserve builder. If successful, the study's findings will be important in shaping policies targeting increasing access to late-life education to reduce dementia risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Literacy training | Experimental | The basic-literacy training will be given for two hours/day for four days/week for 6 months. At baseline, participants will be randomized into four classes of 30. An expert in adult education will oversee the classes and meet the teachers periodically, and each class will count with a certified and experienced lead teacher and teacher aid. The intervention group will receive literacy training based on analytical and phonemic methods for enabling reading and writing |
|
| Non-literacy training | Active Comparator | The comparator group will have access to non-literacy classes offered at the adult school, including geography, history, informatics, and sciences, but no literacy-training, for two hours/day for four days/week for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Literacy training | Behavioral | Teaching adults how to read and write using the analytical and phonemic method |
|
| Measure | Description | Time Frame |
|---|---|---|
| Episodic Memory Improvement | Change in free recall sum-of-attempts of the Free and Cued Selective Reminding with Immediate Recall (FCSR) test. The Free and Cued Selective Reminding Test (FCSRT) is an episodic memory test. First, the participant learns 16 figures, 4 each time, with the help of semantic cues provided by the examiner. After that, the participant recalls the figures 3 times, with a distraction activity between each attempt (counting 20 to 1 backwards). The sum of each immediate free recall is called sum of attempts. It ranges from 0 (the participant does not recall any figure in three attempts) to 48 (the participant recalls all the figures). The higher the score, the better the participant's episodic memory. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Connectivity | The intrinsic functional connectivity will be measured using the BOLD (blood oxygen level dependent) that is calculated through resting state functional MRIs that will be performed at baseline and at 6 months follow up. After preprocessing the images and accounting for potential cofounders (head motion signal, cerebral spinal signal, physiological signal and white matter signal), the BOLD signal is measured and coregistered in T1 images for anatomical correspondence of the signal. Then, a seed is placed in the hippocampus and the BOLD signal between the hippocampus and the prefrontal cortex is calculated at baseline and at 6 months follow up. The higher the value, the more the regions are connected. Change in the intrinsic functional connectivity between the hippocampus and the prefrontal cortex. |
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Inclusion Criteria:
Being illiterate (TOFHLA score <53) and availability to participate in the study for at least 12 months
Exclusion Criteria:
A) Presence of remarkable cognitive complains and/or decompensated psychiatric illness (depression and anxiety) and/or current substance abuse such as alcohol and illicit drugs use.
B) Objective cognitive impairment: score of 2 standard deviations or bellow for age and education on the Mini-Mental State Evaluation (MMSE) and/or score of 6 or lower on the delayed recall task from the Brief Cognitive Battery.
C) History of previously diagnosed dyslexia D) Formal MRI contraindications including metal or claustrophobia. E) Severe structural lesions detected by MRI.
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| Name | Affiliation | Role |
|---|---|---|
| Elisa Resende, MD, PhD | UFMG | Principal Investigator |
| Lea T Grinberg, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | Brazil |
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The assignment of participants to each arm group occured after enrollment. There was no specific event before assigment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Literacy Training | The basic-literacy training will be given for two hours/day for four days/week for 6 months. At baseline, participants will be randomized into four classes of 30. An expert in adult education will oversee the classes and meet the teachers periodically, and each class will count with a certified and experienced lead teacher and teacher aid. The intervention group will receive literacy training based on analytical and phonemic methods for enabling reading and writing Literacy training: Teaching adults how to read and write using the analytical and phonemic method |
| FG001 | Non-literacy Training | The comparator group will have access to non-literacy classes offered at the adult school, including geography, history, informatics, and sciences, but no literacy-training, for two hours/day for four days/week for 6 months. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Literacy Training | The basic-literacy training will be given for two hours/day for four days/week for 6 months. At baseline, participants will be randomized into four classes of 30. An expert in adult education will oversee the classes and meet the teachers periodically, and each class will count with a certified and experienced lead teacher and teacher aid. The intervention group will receive literacy training based on analytical and phonemic methods for enabling reading and writing Literacy training: Teaching adults how to read and write using the analytical and phonemic method |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Episodic Memory Improvement | Change in free recall sum-of-attempts of the Free and Cued Selective Reminding with Immediate Recall (FCSR) test. The Free and Cued Selective Reminding Test (FCSRT) is an episodic memory test. First, the participant learns 16 figures, 4 each time, with the help of semantic cues provided by the examiner. After that, the participant recalls the figures 3 times, with a distraction activity between each attempt (counting 20 to 1 backwards). The sum of each immediate free recall is called sum of attempts. It ranges from 0 (the participant does not recall any figure in three attempts) to 48 (the participant recalls all the figures). The higher the score, the better the participant's episodic memory. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Literacy Training | The basic-literacy training will be given for two hours/day for four days/week for 6 months. At baseline, participants will be randomized into four classes of 30. An expert in adult education will oversee the classes and meet the teachers periodically, and each class will count with a certified and experienced lead teacher and teacher aid. The intervention group will receive literacy training based on analytical and phonemic methods for enabling reading and writing Literacy training: Teaching adults how to read and write using the analytical and phonemic method |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisa de Paula França Resende | Universidade Federal de Minas Gerais | +55 31 3307 9417 | elisa.resende@gbhi.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2021 | May 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2024 | May 3, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2021 | May 3, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Non-Literacy training | Behavioral | Attending classes in geography, history, sciences, without receiving the specific training in literacy |
|
| Baseline and 6 months |
| Physician Decision |
|
| Protocol Violation |
|
| BG001 | Non-literacy Training | The comparator group will have access to non-literacy classes offered at the adult school, including geography, history, informatics, and sciences, but no literacy-training, for two hours/day for four days/week for 6 months. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Free and cued recall sum of attempts | The Free and Cued Selective Reminding Test (FCSRT) is an episodic memory test. First, the participant learns 16 figures, 4 each time, with the help of semantic cues provided by the examiner. After that, the participant recalls the figures 3 times, with a distraction activity between each attempt (counting 20 to 1 backwards). The sum of each immediate free recall is called sum of attempts. It ranges from 0 (the participant does not recall any figure in three attempts) to 48 (the participant recalls all the figures). The higher the score, the better the participant's episodic memory. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Non-literacy Training | The comparator group will have access to non-literacy classes offered at the adult school, including geography, history, informatics, and sciences, but no literacy-training, for two hours/day for four days/week for 6 months. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy |
|
|
|
| Secondary | Change in Brain Connectivity | The intrinsic functional connectivity will be measured using the BOLD (blood oxygen level dependent) that is calculated through resting state functional MRIs that will be performed at baseline and at 6 months follow up. After preprocessing the images and accounting for potential cofounders (head motion signal, cerebral spinal signal, physiological signal and white matter signal), the BOLD signal is measured and coregistered in T1 images for anatomical correspondence of the signal. Then, a seed is placed in the hippocampus and the BOLD signal between the hippocampus and the prefrontal cortex is calculated at baseline and at 6 months follow up. The higher the value, the more the regions are connected. Change in the intrinsic functional connectivity between the hippocampus and the prefrontal cortex. | Some participants had artifacts in their MRIs that made the researchers not able to interpret the resting state functional MRI. Therefore these participants are not included in the analysis for this outcome. | Posted | Mean | Standard Deviation | unitless | Baseline and 6 months |
|
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|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 1 |
| 58 |
| EG001 | Non-literacy Training | The comparator group will have access to non-literacy classes offered at the adult school, including geography, history, informatics, and sciences, but no literacy-training, for two hours/day for four days/week for 6 months. After 6 months, the groups switch, so the comparator receives the specific reading and writing training, and the intervention group receives the lessons on other themes. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy | 0 | 50 | 0 | 50 | 2 | 50 |
| Claustrofobia | Nervous system disorders | Non-systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| t-test, 2 sided |
| 0.120 |
| Mean Difference (Final Values) |
| 0.08 |
| 2-Sided |
| Superiority |