NYU Langone Health
New York, 10016, United States
Location status: Recruiting
NCT Number: NCT06319716
The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Location status: Recruiting
Participants will be randomized with equal allocation to one of the 3 groups. The VIDEO group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The VIDEO+CHW group will receive the same DSMES videos plus bi-weekly support calls from a CHW for 24 weeks. The CHW will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.
CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.
Time frame: Baseline
Time frame: Month 6
Time frame: Month 12
Time frame: Baseline
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 is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.
Time frame: Month 6
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 is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.
Time frame: Month 12
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 is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.
Time frame: Baseline
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health.
Time frame: Month 6
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health.
Time frame: Month 12
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health.
Time frame: Baseline
Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.
Higher MET scores indicate higher weekly levels of physical activity.
Time frame: Month 6
Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.
Higher MET scores indicate higher weekly levels of physical activity.
Time frame: Month 12
Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.
Higher MET scores indicate higher weekly levels of physical activity.
Time frame: Baseline
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 12 to 48, with higher scores indicating more problems with medication adherence.
Time frame: Month 6
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 12 to 48, with higher scores indicating more problems with medication adherence.
Time frame: Month 12
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 12 to 48, with higher scores indicating more problems with medication adherence.
Time frame: Baseline
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. Total scores range from 8 to 40, with higher scores indicating greater perceived emotional support.
Time frame: Month 6
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. Total scores range from 8 to 40, with higher scores indicating greater perceived emotional support.
Time frame: Month 12
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. Total scores range from 8 to 40, with higher scores indicating greater perceived emotional support.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Acronym: LINK-IT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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