Mild Cognitive ImpairmentNCT03933085
Spanish Translation and Cultural Adaptation of the Memory Support System
A study testing Memory Support System (MSS) in people with Mild Cognitive Impairment, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Memory Support System (MSS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Memory Support System (MSS)
- Keywords
- Spanish-Speaking, Hispanic, ages ≥50
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Support System (MSS)Behavioural
A calendar/notetaking system focused on training a person with MCI to use a specific external memory compensatory strategy to complete relevant IADLs independently.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Memory Support System (MSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To assess memory functional ability, care partners will complete a modified version of the Memory Subscale of the Everyday Cognition (E-Cog) at all assessment points. The E-Cog scores range from 8 to 32, where lower scores represent better memory functional ability.
Measured: 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
To assess self-efficacy, participants with subjective memory/cognitive complaints or a diagnosis of MCI will complete a modified version of specific subscales the Self-Efficacy in Memory scale (SEM) (Do Chores, Social/Recreational Activities, and Manage Disease in General) of the Chronic Disease Self-Efficacy Scales at all assessment points. The SEM scores range from 9 to 90, where higher scores represent better self-efficacy.
Measured: 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
To assess mood, participants with subjective memory/cognitive complaints or a diagnosis of MCI and care partners will complete the Center for Epidemiological Studies Depression Scale (CES-D) at all assessment points. The CES-D scores range from 0-60, where higher scores represent more symptoms of depression.
Measured: 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
To assess anxiety, participants with subjective memory/cognitive complaints or a diagnosis of MCI and care partners will complete the Anxiety Inventory Form from the State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project (REACH) at all assessment points. The REACH scores range from 10-40, where higher scores represent more symptoms of anxiety.
Measured: 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
To assess quality of life, participants with subjective memory/cognitive complaints or a diagnosis of MCI and care partners will complete the Quality of Life in Alzheimer's Disease measure (QoL-AD) at all assessment points. The QoL-AD scores range from 13-52, where higher scores represent better quality of life.
Measured: 2 weeks after intervention start and 2-month follow-up
Change from Baseline General Functional Ability at 2 weeks after intervention start and at 2-month follow-up
To assess general functional ability, care partners will complete the Functional Assessment Scale (FAS)
Measured: 2 weeks after intervention start and 2-month follow-up
Change from Baseline Caregiver Burden at 2 weeks after intervention start and at 2-month follow-up
To assess caregiver burden, care partners will complete the Caregiver Burden Interview-Short Form (CBI-SF) at all assessment points. The CBI-SF scores range from 0-48, where higher scores represent more care giver burden.
Measured: 2 weeks after intervention start and 2-month follow-up
Change from Baseline Medication Management Skills at 2 weeks after intervention start and at 2-month follow-up
To assess medication management skills, participants with subjective memory/cognitive complaints or a diagnosis of MCI will complete the Pillbox Test (PT) at all assessment points (≥5 errors considered failure).
Measured: 2 weeks after intervention start and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start6 Mar 2019
- Primary completion28 Feb 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Octavio A. Santos, Mayo Clinic
- Investigators
- Octavio A Santos, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933085
- Sponsor's protocol ID
- 18-008125
- Status last verified
- Oct 2021
- First submitted
- 13 Mar 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All published reports will be of a summary nature, and no individual research subjects will be identified except to the investigative staff involved and only for research purposes. No personal identifying data will be released on subjects without prior consent from the subject. Data will be obtained from study participants via clinical records and interaction with the principal investigator (PI) (Dr. Santos) and/or PI's supervisors (Drs. Chandler and Pedraza). The proposed study will utilize webbased electronic data capture forms using Research Electronic Data Capture (REDCap) software previously created for use in other studies and stored on a server hosted by the Mayo Clinic Center for Translational Science Activities (CTSA) (Grant UL1 RR024150). REDCap is a secure Web-based application for building and managing online databases for clinical research studies. Information in REDCap will be scrubbed of Protected Health Information and utilize research IDs.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Translation and Cultural Adaptation of the Memory Support System
- ClinicalTrials.gov ID
- NCT03933085
- Acronym / sponsor ID
- 18-008125
- Conditions
- Mild Cognitive Impairment
- Keywords
- Spanish-Speaking, Hispanic, ages ≥50
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCI Group | Experimental | Behavioral: Memory Support System (MSS)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MCI Group |
Primary outcome
Change from Baseline Memory Support System (MSS) adherence at 2 weeks after intervention start and at 2-month follow-up
Time frame: 2 weeks after intervention start and 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.
8 secondary outcomes
Change from Baseline Memory functional ability at 2 weeks after intervention start and at 2-month follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 weeks after intervention start and 2-month follow-up
Change from Baseline General Functional Ability at 2 weeks after intervention start and at 2-month follow-up
Time frame: 2 weeks after intervention start and 2-month follow-up
Change from Baseline Caregiver Burden at 2 weeks after intervention start and at 2-month follow-up
Time frame: 2 weeks after intervention start and 2-month follow-up
Change from Baseline Medication Management Skills at 2 weeks after intervention start and at 2-month follow-up
Time frame: 2 weeks after intervention start and 2-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. All published reports will be of a summary nature, and no individual research subjects will be identified except to the investigative staff involved and only for research purposes. No personal identifying data will be released on subjects without prior consent from the subject. Data will be obtained from study participants via clinical records and interaction with the principal investigator (PI) (Dr. Santos) and/or PI's supervisors (Drs. Chandler and Pedraza). The proposed study will utilize webbased electronic data capture forms using Research Electronic Data Capture (REDCap) software previously created for use in other studies and stored on a server hosted by the Mayo Clinic Center for Translational Science Activities (CTSA) (Grant UL1 RR024150). REDCap is a secure Web-based application for building and managing online databases for clinical research studies. Information in REDCap will be scrubbed of Protected Health Information and utilize research IDs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Octavio A Santos, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Support System (MSS) in people with Mild Cognitive Impairment, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Memory Support System (MSS) adherence at 2 weeks after intervention start and at 2-month follow-up (time frame: 2 weeks after intervention start and 2-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.