The PREVENTION Trial: Precision Recommendations to Optimize Neurocognition
Ключавыя словы
Рэферат
Апісанне
Subject identification and recruitment - All participants will be recruited from the Pacific Brain Health Center in Santa Monica, which is a high-volume memory-care and dementia outpatient clinic within a large physician medical group affiliated with Providence Saint John's Health Center. 60 participants will be randomized into the RCT, with 30 in each treatment arm.
Procedures for Obtaining Informed Consent - All participants will receive the Experimental Research Subject's Bill of Rights prior to signing the informed consent form (ICF), authorization of use and disclosure of protected health information (PHI), and authorization of medical record release for the subject's treating physician, will be obtained from each participants prior to enrolling in the study. A copy of all signed ICF's will be given to the participants, and the investigator will retain the original.
A Functional Assessment Staging Test (FAST) will be done before participants are consented to determine whether they or a legally appointed representative (LAR) can consent to participate in the study. In this study, participants with FAST stages 2-4 will be recruited (see Inclusion Criteria).
Considerations for consenting: FAST Stages 2-3 Participants - FAST stages 2-3 participants are usually capable of making medical and legal decisions, and will be consented directly, unless there is a caregiver, legally appointed representative, or other reason to think that an informed consent cannot be given by the participants without approval by a reliable informant acting on their behalf.
Considerations for consenting: FAST Stage 4 (mild dementia) Participants - FAST stage 4 participants will be consented by having them give oral or written assent, indicating their preference with regard to study participation. In addition, the caregiver or legally appointed representative of a demented participants will be consented to assure full understanding of study procedures and willingness on behalf of the participants to participate in the study.
The consenting approach for patients with cognitive impairment has been evaluated by the Department of Psychiatry and Behavioral Sciences at Johns Hopkins, and found to adequately ensure informed consent. They concluded that ADRD participants should not be excluded from study participation if they cannot directly consent themselves, so long as their caregivers can consent, and the participants can assent, either verbally or in writing, their preference to participate in the study.
The caregiver or legally appointed representative will be required to accompany participants to participate in the required procedures. A copy of the appropriate document (e.g., the power of attorney for healthcare) will be obtained and filed with the original ICF.
Даты
| Апошняя праверка: | 08/31/2019 |
| Упершыню прадстаўлена: | 07/23/2019 |
| Меркаваная колькасць заявак прадстаўлена: | 09/04/2019 |
| Першае паведамленне: | 09/08/2019 |
| Апошняе абнаўленне адпраўлена: | 09/04/2019 |
| Апошняе абнаўленне апублікавана: | 09/08/2019 |
| Фактычная дата пачатку даследавання: | 07/11/2019 |
| Разліковая дата першаснага завяршэння: | 04/30/2022 |
| Разліковая дата завяршэння даследавання: | 04/30/2022 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Behavioral: Group 1 - Data-driven clinical recommendations (CR)
Behavioral: Group 2 - Data-driven coached multi-modal intervention (MMIC)
Фаза
Групы ўзбраенняў
| Рука | Ўмяшанне / лячэнне |
|---|---|
| Active Comparator: Group 1 - Data-driven clinical recommendations (CR) Data-driven clinical recommendations (CR) | Behavioral: Group 1 - Data-driven clinical recommendations (CR) Data-driven clinical recommendations. Participants will receive routine care with data-driven, personalized, multi-modal clinical recommendations by a study physician based on study assessments and clinical lab values and be monitored and re-assessed for a period of 12 months. |
| Experimental: Group 2 - Data-driven coached multi-modal intervention (MMIC) Data-driven coached multi-modal intervention (MMIC) | Behavioral: Group 2 - Data-driven coached multi-modal intervention (MMIC) Data-driven multi-modal lifestyle intervention with coaching. Participants will receive coached routine care with data-driven, personalized, multimodal recommendations. MMIC participants will receive an intensive multi-modal intervention with health coaching, support and resources to carry out these recommendations. This additional intervention services include: 13 personal, data-driven brain health coaching sessions (with an RDN), 7 personal dietary counseling sessions (with an RDN), 33 group-based cognitive and physical exercise classes (CogFit) with a certified personal trainer and a computer-based neurocognitive program at home and be monitored and re-assessed for a period of 12 months. |
Крытэрыі прыдатнасці
| Узрост, які мае права на вучобу | 50 Years Каб 50 Years |
| Пол, прыдатны для навучання | All |
| Прымае здаровых валанцёраў | Так |
| Крытэрыі | Inclusion Criteria - Subjects must be age 50 to 80 at time of informed consent. - Subjects of any gender, race or ethnicity are eligible to enroll in the study. - Subjects must have a FAST stage of 2-4. - Subjects with FAST Stage 4 must have a caregiver or legally appointed representative willing to accompany participants to the required procedures. - As part of the study screening procedure, subjects must be willing to undergo an amyloid PET scan or have previously undergone an amyloid PET scan and agree to make the results available. Subjects must be amyloid positive to be eligible to enroll in the study. - Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study (e.g., coaching program) is currently only available in English. - Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable. Subjects should not have started any new medications for chronic conditions within the last three months. - A neurological and physical evaluation will be conducted prior to enrollment of the study by a qualified medical doctor and confirmed through medical records that they do not possess any abnormal physical or neurological sign, and/ whether they are considered to be clinically significant. Also an MMSE >19 will be confirmed by a medical doctor prior to study enrollment. - Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them. - Subjects must be able to converse with a coach telephonically. Video-based telephone coaching is part of data-driven health coaching. - Subjects must have regular access to a computer and the Internet along with dedicated email address since certain aspects of the program (e.g. cognitive training) are delivered electronically. - Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report. - Subject must have adequate hearing acuity as indicated by self-report. - Subject must have adequate motor capacity to use a mobile phone/iPad/computer as indicated by self-report and confirmed by staff before they are enrolled into a treatment arm. - Subject must be cleared by a physician to participate in a moderately intensive exercise program. Exclusion Criteria - Subjects with an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Dementia, Frontal-Temporal Dementia). - Subjects with a diagnosis of cerebrovascular disease as the primary cause of cognitive impairment. - A previously reported AD high-risk mutation (e.g., in the Presenilin Protein (PSEN) or Amyloid Precursor Protein (APP) genes) in the participant or immediate family (children, siblings, or parents). Such patients may accumulate amyloid faster than in late onset AD, and therefore may show less pronounced benefit from intervention. - Mini Mental State Exam (MMSE) below 20. - Clinical Dementia Rating (CDR) global score of 2 or above. |
Вынік
Першасныя вынікі
1. NIH ToolBox Cognition Function Battery - Cognitive Function Composite Score [1 year]
2. RAVLT (Rey's Auditory Verbal Learning Test) score [1 year]
3. Hippocampal Volume [1 year]
Меры другаснага выніку
1. Blood Urine Nitrogen [1 year]
