Memory Support System for Older Chinese Americans With Mild Cognitive Impairment

Official title

A Pilot of Memory Support System for Older Chinese Americans With Mild Cognitive Impairment

Overview

The Memory Support System (MSS) from the Healthy Action to Benefit Independence \& Thinking® (HABIT) Program is an evidence-based, non-pharmacological intervention for mild cognitive impairment (MCI). Despite the clinical benefits and feasibility, the MSS was primarily developed and used with non-Hispanic White, English-speaking adults. Racial/ethnic minority groups are chronically under-enrolled in clinical trials for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) due to lack of linguistically and culturally appropriate adaptation of assessment measures and intervention protocols. The purpose of this research study is to examine whether the MSS from HABIT can help Chinese American older adults with mild thinking and memory problems. Target recruitment is 60 Chinese American adults who are primarily Mandarin- (n=30) and Cantonese-speaking (n=30). Forty participants will participate in the trainer-led day planner training and 20 will participate in self-study of the day planner and receive brain health education. Each participant will also be asked to identify a study partner to participate with them.

Interventions

• Behavioral Memory Support System
  Participants and study partners in the MSS treatment group will work with a study trainer to learn the MSS and eventually adapt the skills to support functioning in their daily life. The MSS trainer will follow a 10-session MSS Training Workbook as the standardized protocol for training. Additional sessions beyond the standard 10 sessions can be added if needed to support mastery of the MSS (up to a maximum of 15 total sessions). Participants and study partners will also receive a copy of the br
• Behavioral Brain Health Education
  Participants and study partners in the control group will be provided with the MSS guidebook and day planner for self-study of the MSS system. They will also meet with a study trainer to complete 10 sessions of a brain health education course that is tailored for individuals with MCI. The trainer will use a HABIT-based brain health education workbook to provide the content. Additional sessions beyond the standard 10 sessions can be added up to a maximum of 15 total sessions. Participants and stu

Primary outcome measures

• Recruitment rate [Time frame: baseline, week 1 of intervention session]
• Retention rate [Time frame: baseline, treatment end (4-9 weeks)]
• Completion rate [Time frame: baseline, treatment end (4-9 weeks)]

Secondary outcome measures (11)

• Everyday Cognition questionnaire [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Functional Activities Questionnaire (FAQ) [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• The Pillbox Test [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Dementia Rating Scale-2 (DRS-2) [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Chronic Disease Self-Efficacy Scales [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Quality of Life in Alzheimer Disease [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Neuropsychiatric Inventory Questionnaire (NPI-Q) - Severity [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Center for Epidemiologic Studies Depression Scale [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Anxiety Inventory Form [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Pittsburgh Sleep Quality Index [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]
• Caregiver Burden Inventory Short-Form [Time frame: at baseline, treatment end (4-9 weeks), and 8-week follow-up]

Eligibility criteria

Inclusion criteria

• self-identify as Chinese American;
• age 55 and above;
• a diagnosis of MCI as confirmed through documented clinical assessment and/or research-based diagnostic criteria;
• predominantly Cantonese- or Mandarin-speaking;
• able to read and write in Chinese;
• visual and auditory acuity adequate for cognitive testing;
• willing to complete the assessment measures;
• having someone in regular contact to serve as a study partner/informant;
• absence or stable use of prescribed memory-enhancing medications within the last 3 months.

Exclusion criteria include:

• any significant neurologic disease that would impact their participation and completion of the trial;
• history of psychiatry disorder (DSM 5 criteria) within the last 12 months;
• history of reading or writing disability sufficient to interfere with MSS training; or
• concurrent participation in another relevant clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Li Lab, Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT07142499 · GCO 22-1738

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗