Spanish Translation and Cultural Adaptation of the Memory Support System

NCT03933085 | Completed

• 1 other identifier: 18-008125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Spanish-Speaking; Hispanic; ages ≥50

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Memory Support System (MSS) adherence at 2 weeks after intervention start and at 2-month follow-up

  To assess MSS adherence (i.e., how well a participant with subjective memory/cognitive complaints or a diagnosis of MCI utilizes all the MSS sections), the therapist will rate each participant based upon four criteria (≥7/10 scores considered compliant) for 2 days randomly selected.

  2 weeks after intervention start and 2-month follow-up

Secondary Outcomes (8)

• Change from Baseline Memory functional ability at 2 weeks after intervention start and at 2-month follow-up

  2 weeks after intervention start and 2-month follow-up

• Change from Baseline Self-efficacy at 2 weeks after intervention start and at 2-month follow-up

  2 weeks after intervention start and 2-month follow-up

• Change from Baseline Mood at 2 weeks after intervention start and at 2-month follow-up

  2 weeks after intervention start and 2-month follow-up

• Change from Baseline Anxiety at 2 weeks after intervention start and at 2-month follow-up

  2 weeks after intervention start and 2-month follow-up

• Change from Baseline Quality of Life at 2 weeks after intervention start and at 2-month follow-up

  2 weeks after intervention start and 2-month follow-up

Other Outcomes (1)

• Intervention evaluation by participants and support partners

  2-month follow-up

Study Arms (1)

MCI Group

EXPERIMENTAL

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.

Behavioral: Memory Support System (MSS)

Interventions

Memory Support System (MSS) 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.

MCI Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training; and/or

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Octavio A Santos, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: May 1, 2019
• Study Start: March 6, 2019
• Primary Completion: February 28, 2020
• Study Completion: July 31, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)