Coaching for Cognition in Alzheimer's (COCOA)
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|ClinicalTrials.gov Identifier: NCT03424200|
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 7, 2019
One major study objective is, using 2 study arms (data-driven health coaching plus RC vs. RC only), to evaluate the efficacy of data-driven health coaching. 'RC only' will serve as the control group. Participants will be enrolled in the trial on the basis of an existence of objective cognitive impairment defined by the MCI Screen (MCIS) and being in one of three functional stages as defined by the Functional Assessment Staging Test (FAST). The three FAST stages correspond to cognitive impairment without functional impairment (FAST 2), cognitive impairment with functional impairment without impairment in instrumental activities of daily living (FAST 3, also known as mild cognitive impairment, MCI), or cognitive impairment with impaired instrumental activities of daily living (FAST 4). Study objectives include measuring treatment related changes in cognitive and functional abilities, quality of life, and biological or biochemical measures.
A second major study objective is to analyze longitudinal multi-omic data from individuals on a trajectory of early-stage dementia, to discover correlations between measured variables, and identify models of causation that can further advance knowledge and research in brain degeneration and healthy living
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Cognitive Impairment||Behavioral: Routine care Other: Coaching plus routine care||Not Applicable|
Up to 200 FAST Stages 2-4 patients with cognitive impairment will be randomized into data-driven health coaching vs. control groups. The participants will be treated and monitored for 24 months.
Subject Identification and Recruitment Study participants will be recruited from a high-volume memory clinic and a large physician medical group. Up to 200 participants will be enrolled in this prospective randomized study (up to 100 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.
FAST staging (see Attachment II for the FAST administrating and scoring) 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 subjects: FAST stages 2-3 participants are usually competent to make 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.
This approach has been evaluated by the Department of Psychiatry and Behavioral Sciences at Johns Hopkins, and found to adequately ensure informed consent (Black et al. 2010). 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Coaching for Cognition in Alzheimer's (COCOA)|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Coaching plus Routine Care
Participants will receive coaching plus routine care
Other: Coaching plus routine care
Participants will receive coaching plus routine care
Participants will receive the routine care
Behavioral: Routine care
Participants will receive routine care
- Coaching for Cognitive Decline [ Time Frame: 2 years ]
Test the hypothesis that coaching is better than no coaching for people in the early stages and at risk for cognitive decline. We plan to test that after two years of coaching, participants in the coaching arm will have higher cognitive scores as measured by the MCI score.
Participants in COCOA will be assessed with the MCIS, which quantifies cognition with the Memory Performance Index (MPI) component score on a 0 to 100 scale (below normal: <50). The MPI will be our primary outcome measure for cognitive function. It is quick and inexpensive to administer. The MPI score is sensitive to slight cognitive deficits, and thus serves as an excellent single measure of cognition to serve as one of our two primary outcome measures Development and validation of the Memory Performance Index: reducing measurement error in recall tests.
- Diagnosis of Alzheimer's Disease [ Time Frame: 2 years ]Measure transition from early and moderate cognitive decline into clinically diagnosed Alzheimer's disease. Our other primary outcome measure is the Functional Assessment Staging Test (FAST) to evaluate overall disease progression. FAST produces ordinal classification (7 major stages, 1-7, with 11 sub-stages, 6a to e and 7a to f. Higher ordinal numbers represent worse outcomes than lower original numbers. Within an equivalent ordinal number, later letters of the alphabet represent worse outcomes. (Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int. Psychogeriatr. 1992;4 Suppl 1:55-69)
- Memory Performance Index [ Time Frame: 2 years ]The Memory Performance Index is a quantitative measure of cognitive function. The MPI scale ranges from 0 to 100. It is a component of the MCI Screen. The MCI Screen's components measure the respondent's performance in terms of: pattern of words recalled immediately and after a delay attention and concentration, judgment and reasoning, and short term memory.
- FAST Stage [ Time Frame: 2 years ]The Functional Assessment Staging Test (FAST) measures functional status. FAST Stage 1 is normal. Other stages correspond to: cognitive impairment without functional impairment (FAST 2), cognitive impairment with functional impairment but without impairment in instrumental activities of daily living (FAST 3, also known as mild cognitive impairment, MCI), or cognitive impairment with impaired instrumental activities of daily living (FAST 4). Measures the effect of the intervention on functional status. FAST stage 4 is a surrogate for a clinical diagnosis of Alzheimer's disease.
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): NCT03424200
|Contact: Laura Heim, RN||(949) 764-8190||Laura.firstname.lastname@example.org|
|United States, California|
|Hoag Memorial Hospital Presbyterian||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Deborah Fridman, PsyD 949-764-4430 Deborah.email@example.com|
|Principal Investigator: William Shankle, MD|
|Study Director:||Deborah Fridman, PsyD||Hoag Memorial Hospital Presbyterian|