Type 2 Diabetes
Conditions
Brief summary
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 Americans with uncontrolled type 2 diabetes in NYC.
Detailed description
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.
Interventions
BEHAVIORALVideo-Based Diabetes Self-Management Education and Support (DSMES)
The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.
BEHAVIORALCommunity Health Worker (CHW) Support
CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.
Sponsors
NYU Langone Health
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* self-identify as ethnically Chinese; * be above 18 years old; * have a diagnosis of Type 2 diabetes (T2D) in the medical record; * have an HbA1c≥7% in the past 12 months * be willing to participate in video-based interventions; and * possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.
Exclusion criteria
* unable or unwilling to provide informed consent; * unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment); * unwilling to accept randomization assignment; * is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study; or * is breastfeeding (e.g., they may have potential dietary restrictions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c) Levels | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stanford Self-Efficacy for Diabetes Scale Score | 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 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 | Baseline | 8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors. |
| International Physical Activity Questionnaire (IPAQ) Short-Version Score | 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. |
| Adherence to Refills and Medications Scale for Diabetes (ARMS-D) | 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 11 to 44, with higher scores indicating more problems with medication adherence. |
| Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales | 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. |
| Diabetes-Related Distress | Baseline | 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 | Baseline | 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 | Baseline | 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 | Baseline | 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. |
Countries
United States
Contacts
CONTACTLu Hu, PhD
PRINCIPAL_INVESTIGATORLu Hu, PhD
NYU Langone Health
Outcome results
None listed