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| Name | Class |
|---|---|
| Northwell Health | OTHER |
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The purpose of this research study is to compare the impact of providing culturally-tailored, diabetes management education in a group setting to standard diabetes care. We are conducting this study because previous research has demonstrated culturally tailored care can be effective in addressing health disparities. However, it has not been offered in a group setting, among Native Hawaiians and Pacific Islanders who share similar social experiences.
The purpose of this small R01 is to test the feasibility and preliminary efficacy of a family-based DSMES and social care navigation intervention to improve diabetes-related outcomes among NHPI patients with poorly managed diabetes and social needs. KP Hawaii NHPI patients (N = 80) age ≥ 18, recent A1C >8%, and who report >1 social needs will be recruited and randomized to one of two study arms: 1) family-based group centered DSMES and social care navigation intervention; or 2) enhanced usual care. In the family-based intervention, participants and their family members will receive the 6-week NHPI culturally adapted DSMES program that will be delivered by a NHPI pharmacist from the Mauliola Pharmacy. In collaboration with our partners, Hui No Ke Ola Pono, a community-based organization that employs CHWs, enrolled participants and their family members will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months. Participants in the enhanced usual care arm will receive standard diabetes clinical care and be provided with a tailored community-based resource list. Feasibility will be determined using mixed methods and based on recruitment, retention, attendance, social need resolution, and several implementation outcomes. We will also examine intervention preliminary effects on diabetes distress, self-management, self-efficacy/empowerment, A1C, and healthcare utilization at 6 months. We propose the following aims:
Aim 1. Determine feasibility of the family-based group centered DSMES and social care navigation intervention based on: a) recruitment and retention rates; b) session attendance; c) number of participants with social need(s) met, not met, or pending at 6 months; d) acceptability; e) practicality; f) fidelity; and g) cultural appropriateness.
Aim 2. Explore preliminary efficacy by comparing the two study arms on the following outcomes at 6-months post-randomization: a) diabetes distress; b) diabetes self-management; c) diabetes self-efficacy; d) mean change in A1C; e) proportion of participants with a clinic-based A1C test; and f) proportion of patients who attended a scheduled follow-up primary care appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-based group-centered DSMES plus social care navigation intervention | Experimental | In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner. Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months. |
|
| Enhanced routine care | Active Comparator | Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-based group-centered DSMES plus social care navigation intervention | Behavioral | In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner. Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the family-based DSMES and social care intervention | Fidelity
| 6-months follow-up |
| Feasibility of the family-based DSMES and social care intervention | Fidelity
| 6-months follow-up |
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Inclusion Criteria:
Exclusion Criteria: Patients who are not able to provide informed consent due to cognitive impairment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maile Taualii, PhD, MPH | Contact | 808-462-1437 | maile.m.taualii@kp.org | |
| Jonathan Lai | Contact | 808- 476-1747 | jonathan.ws.lai@kp.org |
| Name | Affiliation | Role |
|---|---|---|
| Maile Taualii, PhD, MPH | Kaiser Permanente | Principal Investigator |
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Confidential Patient Information
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Eligible patients will be randomized to one of two study arms:
Ho'okele: a family-based group-centered Diabetes Self-Management Education and Support (DSMES) plus social care navigation intervention;
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, Native Hawaiians and Pacific Islanders (NHPI) culturally adapted Diabetes Self-Management Education and Support (DSMES) program offered by a NHPI community partner. Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
enhanced routine care.
Participants in the enhanced routine care arm will receive the standard diabetes clinical care at Kaiser Permanente Hawaii and be provided with a tailored community-based resource list.
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Randomization after recruitment
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| Enhanced routine care | Behavioral | Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list. |
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