Clinical trial NCT03424200: Coaching for Cognition in Alzheimer's (COCOA)
Official title: Coaching for Cognition in Alzheimer's (COCOA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
Collaborators: name: Institute for Systems Biology
name: Arivale
First posted: 2018-02-06
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants must be age 50 and older (no age upper limit) at time of informed consent.
* Adults of any gender, race or ethnicity are eligible to enroll in the study.
* Participants must have cognitive impairment as demonstrated by a Memory Performance Index (MPI) of 50 or below, or delayed free recall score of 6 or below if MPI is greater than 50.
* Participants must have a FAST stage of 2-4.
* Participants with FAST Stage 4 must have the caregiver or legally appointed representative who can provide an appropriate documents (e.g., the power of attorney for healthcare)
* Participants 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.
* Participants with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
* Participants, 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.
* Participants must be able to converse with a coach telephonically. Telephone coaching is part of data-driven health coaching.
* Participants 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.
* Participants must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report
* Participants must have adequate hearing acuity as indicated by self-report
* Participants must have adequate motor capacity to use a mobile device/iPad/computer as indicated by self-report

Exclusion Criteria:

* Participants with an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Disease, Frontal-Temporal Disease).
* Participants with a diagnosis of cerebrovascular disease as the primary cause of cognitive impairment.
* Participants who have participated in the Arivale program or the HPWP. These employed coaching similar to the approach that will be used in the current study.
* A previously reported AD high-risk mutation (e.g., in the PSEN or 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.

Primary outcomes:
measure: Coaching for Cognitive Decline
timeFrame: 2 years
Secondary outcomes:
measure: Diagnosis of Alzheimer's Disease
timeFrame: 2 years
measure: Memory Performance Index
timeFrame: 2 years
measure: FAST Stage
timeFrame: 2 years
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Hoag Memorial Hospital Presbyterian
name: Leila Andres, MA
role: STUDY_DIRECTOR
References: