移民の健康の社会的決定要因に対処するためにビデオと地域医療従事者を活用する (LINK-IT)

実験的：ビデオ

ビデオ部門に割り当てられた参加者は、24 週間にわたって週に 1 つの短い糖尿病自己管理教育とサポート (DSMES) ビデオを受け取ります。 動画はテキストメッセージで配信されます。

行動：ビデオベースの糖尿病自己管理教育とサポート (DSMES)

DSMES ビデオは、参加者に重要な糖尿病教育を提供し、参加者が個人レベルで活性化された患者になるよう支援します。

実験的：ビデオ+CHW

VIDEO+CHW 部門に割り当てられた参加者は、地域医療従事者 (CHW) から隔週でのサポート電話に加えて、週に 1 つの短い DSMES ビデオを 24 週間受け取ります。 DSMES ビデオはテキスト メッセージで配信されます。

行動：ビデオベースの糖尿病自己管理教育とサポート (DSMES)

DSMES ビデオは、参加者に重要な糖尿病教育を提供し、参加者が個人レベルで活性化された患者になるよう支援します。

行動：地域医療従事者 (CHW) のサポート

CHW は、2 型糖尿病治療に対する参加者の健康の社会的決定要因 (SDOH) の障壁を評価し、それらを地域社会で利用可能なリソースに結び付けます。

介入なし：CONTROL

Participants assigned to the CONTROL group will continue to receive usual care. At the end of the study, they will receive DSMES videos.

ヘモグロビン A1c (HbA1c) レベル

ヘモグロビン A1c (HbA1c) レベル

ヘモグロビン A1c (HbA1c) レベル

国際身体活動アンケート (IPAQ) の短縮版スコア

自己評価では、参加者が 3 つのカテゴリの身体活動 (激しい活動、中程度の活動、および歩行活動) に従事する週当たりの推定分数を提供します。 結果は、1 週間あたりの代謝当量 (MET) 分で表されます。 MET 分は、身体活動を行うために消費されるエネルギー量を表します。 MET の計算式は次のとおりです: 8 (激しい活動) (分) + 4 (中程度の活動) (分) + 3.3 (歩行活動) (分) = MET。

MET スコアが高いほど、毎週の身体活動レベルが高いことを示します。

国際身体活動アンケート (IPAQ) の短縮版スコア

自己評価では、参加者が 3 つのカテゴリの身体活動 (激しい活動、中程度の活動、および歩行活動) に従事する週当たりの推定分数を提供します。 結果は、1 週間あたりの代謝当量 (MET) 分で表されます。 MET 分は、身体活動を行うために消費されるエネルギー量を表します。 MET の計算式は次のとおりです: 8 (激しい活動) (分) + 4 (中程度の活動) (分) + 3.3 (歩行活動) (分) = MET。

MET スコアが高いほど、毎週の身体活動レベルが高いことを示します。

国際身体活動アンケート (IPAQ) の短縮版スコア

自己評価では、参加者が 3 つのカテゴリの身体活動 (激しい活動、中程度の活動、および歩行活動) に従事する週当たりの推定分数を提供します。 結果は、1 週間あたりの代謝当量 (MET) 分で表されます。 MET 分は、身体活動を行うために消費されるエネルギー量を表します。 MET の計算式は次のとおりです: 8 (激しい活動) (分) + 4 (中程度の活動) (分) + 3.3 (歩行活動) (分) = MET。

MET スコアが高いほど、毎週の身体活動レベルが高いことを示します。

Stanford Self-Efficacy for Diabetes Scale Score

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.

Stanford Self-Efficacy for Diabetes Scale Score

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.

Stanford Self-Efficacy for Diabetes Scale Score

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.

Starting the Conversation (STC) Diet Scale Score

8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.

Starting the Conversation (STC) Diet Scale Score

8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.

Starting the Conversation (STC) Diet Scale Score

8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.

Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

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.

Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

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.

Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

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.

Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

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.

Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

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.

Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

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.

Diabetes-Related Distress

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.

Diabetes-Related Distress

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.

Diabetes-Related Distress

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.

SDOH Barriers

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.

SDOH Barriers

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.

SDOH Barriers

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.

Health-Related Social Needs

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.

Health-Related Social Needs

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.

Health-Related Social Needs

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.

Cognitive Function

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.

Cognitive Function

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.

Cognitive Function

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.