Spanish Translation and Cultural Adaptation of the Memory Support System

NCT ID: NCT03933085

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2021-07-31

Brief Summary

This study seeks to translate a proven cognitive treatment for Spanish-speaking Hispanics with subjective memory/cognitive complaints or a diagnosis of mild cognitive impairment (MCI) and their care partners. MCI causes cognitive changes that are noticed by the individual or others. These changes do not significantly interfere with independence. MCI also increases the risk of developing Alzheimer's or another dementia, particularly in Hispanics/Latinos. There is no medication that improves cognition or delays MCI. However, providing cognitive treatment can alleviate the effects of MCI. Only a few cognitive interventions have been proven effective in the U.S., but none has been adapted to the Spanish-speaking Hispanic community. Our proposed cognitive treatment uses effective strategies (e.g., calendar and notetaking) to compensate for memory loss. The investigators will first follow international guidelines to ensure proper translation of our treatment into Spanish. Then, the investigators will pilot test our translated intervention in 20 Spanish-speaking Hispanic participants with subjective memory/cognitive complaints or a diagnosis of MCI and their care partners (40 participants total). The investigators will also assess the degree to which participants follow medical advice; their beliefs in their ability to succeed in and do daily activities, including managing medications; their feelings and potential burden associated with caregiving before and after the treatment as well as 8 weeks later. Results will allow the investigators to determine whether our treatment was effective and to calculate the number of participants required for larger studies. Overall, the study represents an important step to respond to the needs of the Hispanic community.

Detailed Description

Mild cognitive impairment (MCI) constitutes a high-risk state for conversion to dementia, making the search for interventions an urgent priority. In the absence of medications or dietary agents that improve cognition or delay MCI progression, offering nonpharmacological care approaches is currently considered good practice. Despite that, there are only a few evidence-based cognitive interventions for individuals with MCI available in the U.S. and, to the best of our knowledge, none is culturally sensitive to Hispanics; a group more prone to Alzheimer's disease or other dementias compared to non-Hispanic Whites. The overall goal and primary aim of this pilot project is to translate and begin to culturally adapt an evidence-based compensatory cognitive rehabilitation intervention, the Memory Support System (MSS), for Spanish-speaking Hispanics with subjective memory/cognitive complaints or a diagnosis of MCI and their care partners residing in the U.S. The MSS is a calendar/notetaking intervention proven effective in helping those with MCI compensate for memory loss in day-to-day function. Translation of the MSS and other materials will follow international guidelines. The Spanish MSS will be piloted in a sample of 20 participants in a within-subject, pre- and post-intervention assessment design. Outcome measures of program adherence, functional memory/general ability, self-efficacy, mood, anxiety, medication management skills, quality of life, and caregiver burden will be administered before and after the intervention, as well as at 8-week post-intervention to estimate effect size for power analyses for use in a future between-subject random assignment multicenter clinical trial. Overall, this pilot project represents an important step to significantly contribute to the development and promotion of clinical neuropsychological interventions responsive to the needs of the Hispanic community.

Conditions

Mild Cognitive Impairment

Keywords

Spanish-Speaking; Hispanic; ages ≥50

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MCI Group

A within-subject, multiple baseline design, with each subject serving as their own control,4 will be implemented to get the maximum number of participants trained in the use of the MSS during the proposed funding period. This 2-year study will involve four phases: a 4-month translation and cultural adaptation development phase, a 12-month recruitment and treatment implementation phase, a 6-month post data collection only phase, and a 2-month data analysis and result writing phase. Data analyses will be conducted using the Statistical Package for the Social Sciences (SPSS) program.

Group Type: EXPERIMENTAL

Memory Support System (MSS)

Intervention Type: BEHAVIORAL

A calendar/notetaking system focused on training a person with MCI to use a specific external memory compensatory strategy to complete relevant IADLs independently.

Interventions

Memory Support System (MSS)

A calendar/notetaking system focused on training a person with MCI to use a specific external memory compensatory strategy to complete relevant IADLs independently.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subjective memory/cognitive complaints or a diagnosis of single or multi-domain MCI
• Global score of ≤0.5 on the Clinical Dementia Rating (CDR)
• Scores of ≥4 on items six to nine on the Linguistic History Form (CLS) and scores of ≤6 on items on the Functional Assessment Scale (FAS), when applicable, from the Spanish language Uniformed Data Set (UDS) from the National Alzheimer's Coordinating Center's (NACC);
• A score of ≥115 on the Spanish Translation of the Dementia Rating Scale-Second edition (ST-DRS-2);
• Having contact with a cognitively normal care partner screened with the Mini Mental Status Examination (MMSE ≥24) at least twice a week; and
• Either not taking or stable on nootropic(s) for at least 3 months.

Exclusion Criteria

• Visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training; and/or
• Inclusion in another clinical trial that would exclude participation; subject will be considered for participation at the end of such a trial or as appropriate.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Octavio A. Santos

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Octavio A Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Jacksonville, Florida, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-008125

Identifier Type: -

Identifier Source: org_study_id