- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06319716
이민자의 건강에 대한 사회적 결정 요인을 다루기 위해 비디오와 지역 사회 보건 종사자를 활용 (LINK-IT)
LINK-IT: 이민자의 건강에 대한 사회적 결정요인을 해결하기 위해 비디오 및 지역 사회 보건 종사자를 활용
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Lu Hu, PhD
- 전화번호: 646-501-3438
- 이메일: Lu.hu@nyulangone.org
연구 장소
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New York
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New York, New York, 미국, 10016
- 모병
- NYU Langone Health
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 자신을 중국 이민자로 식별합니다.
- 18~70세 사이여야 합니다.
- 의료 기록에 제2형 당뇨병(T2D) 진단이 있습니다.
- 지난 12개월 이내에 정기적인 T2D 치료를 위해 의사와 약속을 잡았습니다.
- 최근 HbA1c 수치가 8% 이상입니다.
- T2D 관리에 관한 간략한 비디오를 기꺼이 받아보십시오. 그리고
- 스마트폰을 가지고 있거나, 스마트폰이 없다면 학습용 스마트폰을 기꺼이 사용할 수 있어야 합니다.
제외 기준:
- 사전 동의를 제공할 수 없거나 제공할 의사가 없는 경우
- 개입에 의미 있게 참여할 수 없음(예: 교정되지 않은 시력 및 청각 장애)
- 무작위 할당을 받아들이지 않음;
- 임신 중이거나, 향후 6개월 내에 임신할 계획이거나, 연구 중에 임신하게 된 경우, 또는
- 모유 수유 중입니다(예: 잠재적인 식이 제한이 있을 수 있음).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 동영상
VIDEO 부문에 배정된 참가자는 24주 동안 매주 간단한 당뇨병 자가 관리 교육 및 지원(DSMES) 비디오 1개를 받게 됩니다.
영상은 문자 메시지로 전달됩니다.
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DSMES 비디오는 참가자들에게 중요한 당뇨병 교육을 제공하고 그들이 개인 수준에서 활성화된 환자가 되도록 힘을 실어줍니다.
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실험적: 비디오+CHW
VIDEO+CHW 부서에 배정된 참가자는 24주 동안 지역사회 의료 종사자(CHW)의 격주 지원 전화 외에 매주 간단한 DSMES 비디오 1개를 받게 됩니다.
DSMES 영상은 문자 메시지로 전달됩니다.
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DSMES 비디오는 참가자들에게 중요한 당뇨병 교육을 제공하고 그들이 개인 수준에서 활성화된 환자가 되도록 힘을 실어줍니다.
CHW는 제2형 당뇨병 치료에 대한 참가자의 SDOH(사회적 건강 결정 요인) 장벽을 평가하고 이를 지역 사회에서 이용 가능한 자원과 연결합니다.
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간섭 없음: CONTROL
Participants assigned to the CONTROL group will continue to receive usual care.
At the end of the study, they will receive DSMES videos.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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헤모글로빈 A1c(HbA1c) 수치
기간: 기준선
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기준선
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헤모글로빈 A1c(HbA1c) 수치
기간: 6개월
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6개월
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헤모글로빈 A1c(HbA1c) 수치
기간: 12개월
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12개월
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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국제 신체 활동 설문지(IPAQ) 단기 버전 점수
기간: 기준선
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참가자는 격렬한 활동, 중간 정도의 활동, 걷기 활동 등 세 가지 신체 활동 범주에 참여하여 주당 추정 시간(분)을 제공하는 자가 평가를 수행합니다. 결과는 주당 대사량(MET) 분으로 표시됩니다. MET 분은 신체 활동을 수행하는 데 소비되는 에너지의 양을 나타냅니다. MET 계산 공식은 다음과 같습니다: 8(강한 활동)(분) + 4(보통 활동)(분) +3.3(걷기 활동)(분) = MET. MET 점수가 높을수록 주간 신체 활동 수준이 높다는 것을 의미합니다. |
기준선
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국제 신체 활동 설문지(IPAQ) 단기 버전 점수
기간: 6개월
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참가자는 격렬한 활동, 중간 정도의 활동, 걷기 활동 등 세 가지 신체 활동 범주에 참여하여 주당 추정 시간(분)을 제공하는 자가 평가를 수행합니다. 결과는 주당 대사량(MET) 분으로 표시됩니다. MET 분은 신체 활동을 수행하는 데 소비되는 에너지의 양을 나타냅니다. MET 계산 공식은 다음과 같습니다: 8(강한 활동)(분) + 4(보통 활동)(분) +3.3(걷기 활동)(분) = MET. MET 점수가 높을수록 주간 신체 활동 수준이 높다는 것을 의미합니다. |
6개월
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국제 신체 활동 설문지(IPAQ) 단기 버전 점수
기간: 12개월
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참가자는 격렬한 활동, 중간 정도의 활동, 걷기 활동 등 세 가지 신체 활동 범주에 참여하여 주당 추정 시간(분)을 제공하는 자가 평가를 수행합니다. 결과는 주당 대사량(MET) 분으로 표시됩니다. MET 분은 신체 활동을 수행하는 데 소비되는 에너지의 양을 나타냅니다. MET 계산 공식은 다음과 같습니다: 8(강한 활동)(분) + 4(보통 활동)(분) +3.3(걷기 활동)(분) = MET. MET 점수가 높을수록 주간 신체 활동 수준이 높다는 것을 의미합니다. |
12개월
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Stanford Self-Efficacy for Diabetes Scale Score
기간: Baseline
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8-item self-assessment of participants' confidence level in performing specific self-management behaviors.
Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident).
The total score can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
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Baseline
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Stanford Self-Efficacy for Diabetes Scale Score
기간: Month 6
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8-item self-assessment of participants' confidence level in performing specific self-management behaviors.
Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident).
The total score can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
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Month 6
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Stanford Self-Efficacy for Diabetes Scale Score
기간: Month 12
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8-item self-assessment of participants' confidence level in performing specific self-management behaviors.
Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident).
The total score can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
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Month 12
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Starting the Conversation (STC) Diet Scale Score
기간: Baseline
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8-item self-report questionnaire measuring dietary behaviors.
Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
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Baseline
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Starting the Conversation (STC) Diet Scale Score
기간: Month 6
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8-item self-report questionnaire measuring dietary behaviors.
Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
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Month 6
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Starting the Conversation (STC) Diet Scale Score
기간: Month 12
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8-item self-report questionnaire measuring dietary behaviors.
Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
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Month 12
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Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
기간: Baseline
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ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months.
Responses range from 1 ("none of the time") to 4 ("all of the time").
Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.
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Baseline
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Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
기간: Month 6
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ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months.
Responses range from 1 ("none of the time") to 4 ("all of the time").
Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.
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Month 6
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Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
기간: Month 12
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ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months.
Responses range from 1 ("none of the time") to 4 ("all of the time").
Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.
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Month 12
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Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales
기간: Baseline
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8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.
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Baseline
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Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales
기간: Month 6
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8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.
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Month 6
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Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales
기간: Month 12
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8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.
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Month 12
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Diabetes-Related Distress
기간: Baseline
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Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes.
Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem").
The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.
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Baseline
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Diabetes-Related Distress
기간: Month 6
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Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes.
Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem").
The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.
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Month 6
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Diabetes-Related Distress
기간: Month 12
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Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes.
Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem").
The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.
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Month 12
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SDOH Barriers
기간: Baseline
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The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use).
Items used dichotomous response options (1 = "Yes"; 0 = "No").
An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.
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Baseline
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SDOH Barriers
기간: Month 6
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The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use).
Items used dichotomous response options (1 = "Yes"; 0 = "No").
An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.
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Month 6
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SDOH Barriers
기간: Month 12
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The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use).
Items used dichotomous response options (1 = "Yes"; 0 = "No").
An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.
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Month 12
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Health-Related Social Needs
기간: Baseline
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Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool.
The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability.
These domains identify social needs that may be addressed through clinical and community-based services.
Each domain includes its own set of indicators.
Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables.
For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.
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Baseline
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Health-Related Social Needs
기간: Month 6
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Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool.
The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability.
These domains identify social needs that may be addressed through clinical and community-based services.
Each domain includes its own set of indicators.
Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables.
For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.
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Month 6
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Health-Related Social Needs
기간: Month 12
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Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool.
The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability.
These domains identify social needs that may be addressed through clinical and community-based services.
Each domain includes its own set of indicators.
Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables.
For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.
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Month 12
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Cognitive Function
기간: Baseline
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Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment.
Total scores range from 0 to 15, with higher scores indicating better cognitive function.
A score below 11 may indicate cognitive impairment and warrant further evaluation.
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Baseline
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Cognitive Function
기간: Month 6
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Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment.
Total scores range from 0 to 15, with higher scores indicating better cognitive function.
A score below 11 may indicate cognitive impairment and warrant further evaluation.
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Month 6
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Cognitive Function
기간: Month 12
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Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment.
Total scores range from 0 to 15, with higher scores indicating better cognitive function.
A score below 11 may indicate cognitive impairment and warrant further evaluation.
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Month 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lu Hu, PhD, NYU Langone Health
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 23-01274
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .