Clinical trial NCT03933085: Spanish Translation and Cultural Adaptation of the Memory Support System
Official title: Spanish Translation and Cultural Adaptation of the Memory Support System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Spanish-Speaking
Hispanic
ages ≥50
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline Memory Support System (MSS) adherence at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
Secondary outcomes:
measure: Change from Baseline Memory functional ability at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
measure: Change from Baseline Self-efficacy at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
measure: Change from Baseline Mood at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
measure: Change from Baseline Anxiety at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
measure: Change from Baseline Quality of Life at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
measure: Change from Baseline General Functional Ability at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
measure: Change from Baseline Caregiver Burden at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
measure: Change from Baseline Medication Management Skills at 2 weeks after intervention start and at 2-month follow-up
timeFrame: 2 weeks after intervention start and 2-month follow-up
Other outcomes:
measure: Intervention evaluation by participants and support partners
timeFrame: 2-month follow-up
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Octavio A Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: