Status:
COMPLETED
Coaching for Cognition in Alzheimer's (COCOA)
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Collaborating Sponsors:
Institute for Systems Biology
Arivale
Conditions:
Alzheimer Disease
Cognitive Impairment
Eligibility:
All Genders
50+ years
Phase:
NA
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. ...
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. Subj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03424200
Start Date
January 10 2018
End Date
January 1 2022
Last Update
September 26 2022
Active Locations (1)
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1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663