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出境医 / 临床实验 / Latinos Understanding the Need for Adherence in Diabetes (LUNA-D)
Latinos Understanding the Need for Adherence in Diabetes (LUNA-D)
Study Description
Brief Summary:
The Latinos Understanding the Need for Adherence in Diabetes (LUNA-D) study, is a randomized controlled trial testing the effectiveness of an integrated behavioral health and primary care chronic care disease management intervention for low income Latino patients with type-2 diabetes mellitus (T2DM) that have 2 or more chronic health conditions. LUNA-D focuses on diabetes management and behavioral health care integration.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Glycemic Control Cardiovascular Risk Factors Psychological Distress | Behavioral: Special Intervention | Not Applicable |
Detailed Description:
LUNA-D proposes to test the ability of a fully integrated behavioral health and primary care diabetes management intervention in a federally-qualified community health care setting to improve multiple clinical and behavioral outcomes. LUNA-D will recruit non-insulin using adult type two diabetes mellitus (T2DM) patients with two or more chronic diseases. Half will be randomized to the Special Intervention (SI) arm and half to the Usual Care (UC) arm. The SI is an intensive intervention including fully integrated clinical visits with a medical provider (MP) co-located with a behavioral health counselor (BHC) and peer-led evidence-based group health education sessions and proactive care coordination. Usual Care is represented by passive appointments with the primary care physician and passive referrals to behavioral health and traditional health education. Biological measurements will be taken at baseline, 3-, 6-, 9- and 12-months to detect changes in glycemic control. Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 456 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Latinos Understanding the Need for Adherence in Diabetes |
| Actual Study Start Date : | July 16, 2015 |
| Actual Primary Completion Date : | December 18, 2018 |
| Actual Study Completion Date : | December 31, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Special Intervention
The special intervention (SI) arm addresses glycemic control, medication adherence, control of modifiable CVD risk factors, health behavior change, and psychosocial and cultural barriers to self-management. The SI arm consists of a collaborative care team approach with four main elements including: 1) Specialized clinical care by a medical provider; 2) Specialized behavioral health care by a behavioral health provider; 3) Group-based chronic disease self-management education by peer-leaders; 4) Intensive, proactive care coordination facilitated by a patient registry and electronic health records.
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Behavioral: Special Intervention
The components of the Special Intervention (SI) integrated design are: 1) Co-location of the clinical team; 2) Shared medical plan; 3) Clinical visits with a medical provider for management of chronic medical conditions; 4) Visits with behavioral health provider for management of psychosocial chronic conditions; 5) Care coordination; 6) Six group-health education classes and two booster sessions led by a promotora. Participants in the SI arm meet with the integrated care team in the context of a regular medical visit primarily to focus on clinical/biological aspects of the chronic medical conditions (diabetes, dyslipidemia, hypertension, obesity, etc.)
Other Names:
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No Intervention: Usual Care
Participants randomized to the Usual Care (UC) arm continue to see their primary care provider and receive referrals to health education. At the discretion of the provider, UC patients are screened and referred to behavioral health (BH) care.
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Outcome Measures
Primary Outcome Measures :
- HbA1c Blood Value [ Time Frame: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC). ]The primary outcome is change in HbA1c values among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Secondary Outcome Measures :
- Body Mass Index (BMI) [ Time Frame: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC). ]Lower BMI among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
- Total Cholesterol [ Time Frame: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC). ]Lower cholesterol levels among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
- Blood Pressure (BP) [ Time Frame: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC). ]Improve the ratio of systolic to diastolic blood pressure among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
- Patient Health Questionnaire (PHQ-8) [ Time Frame: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC). ]Improve depression symptomatology among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
- Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC). ]Improve anxiety symptomatology among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
This study targets non-insulin using T2DM patients with 2 or more chronic conditions. The primary eligibility criteria are as follows:
- Self-identify as Hispanic/Latino
- Be a registered & established patient of SYH
- 18 years of age or older
- Have an established diagnosis of T2DM (but not currently using insulin)
- Not currently participating in any other diabetes or CVD intervention program
- Have 2 or more CVD risk factors (e.g., depression, anxiety, hypertension, dyslipidemia, obesity, or smoking)
Exclusion Criteria:
Individuals will be excluded if they:
- Are pregnant or planning to get pregnant (temporary exclusion, may qualify 6-months postpartum)
- Have plans to move out of the area in the next 12 months
- Have pre-existing health problems so severe as to prohibit informed consent and study attendance
- Have severe diabetes, including renal disease and/or on dialysis
- Have severe psychosocial conditions under the care of a psychiatrist (e.g., severe depression, bipolar disorder, or schizophrenia)
Contacts and Locations
Locations
| United States, California | |
| South Bay Latino Research Center | |
| Chula Vista, California, United States, 91910 | |
Sponsors and Collaborators
San Diego State University
Investigators
| Principal Investigator: | Gregory A Talavera, MD/MPH | SDSU |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 7, 2019 | ||||
| First Posted Date ICMJE | June 12, 2019 | ||||
| Last Update Posted Date | June 12, 2019 | ||||
| Actual Study Start Date ICMJE | July 16, 2015 | ||||
| Actual Primary Completion Date | December 18, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HbA1c Blood Value [ Time Frame: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC). ] The primary outcome is change in HbA1c values among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Latinos Understanding the Need for Adherence in Diabetes | ||||
| Official Title ICMJE | Latinos Understanding the Need for Adherence in Diabetes | ||||
| Brief Summary | The Latinos Understanding the Need for Adherence in Diabetes (LUNA-D) study, is a randomized controlled trial testing the effectiveness of an integrated behavioral health and primary care chronic care disease management intervention for low income Latino patients with type-2 diabetes mellitus (T2DM) that have 2 or more chronic health conditions. LUNA-D focuses on diabetes management and behavioral health care integration. | ||||
| Detailed Description | LUNA-D proposes to test the ability of a fully integrated behavioral health and primary care diabetes management intervention in a federally-qualified community health care setting to improve multiple clinical and behavioral outcomes. LUNA-D will recruit non-insulin using adult type two diabetes mellitus (T2DM) patients with two or more chronic diseases. Half will be randomized to the Special Intervention (SI) arm and half to the Usual Care (UC) arm. The SI is an intensive intervention including fully integrated clinical visits with a medical provider (MP) co-located with a behavioral health counselor (BHC) and peer-led evidence-based group health education sessions and proactive care coordination. Usual Care is represented by passive appointments with the primary care physician and passive referrals to behavioral health and traditional health education. Biological measurements will be taken at baseline, 3-, 6-, 9- and 12-months to detect changes in glycemic control. Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Special Intervention
The components of the Special Intervention (SI) integrated design are: 1) Co-location of the clinical team; 2) Shared medical plan; 3) Clinical visits with a medical provider for management of chronic medical conditions; 4) Visits with behavioral health provider for management of psychosocial chronic conditions; 5) Care coordination; 6) Six group-health education classes and two booster sessions led by a promotora. Participants in the SI arm meet with the integrated care team in the context of a regular medical visit primarily to focus on clinical/biological aspects of the chronic medical conditions (diabetes, dyslipidemia, hypertension, obesity, etc.)
Other Names:
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
456 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 31, 2018 | ||||
| Actual Primary Completion Date | December 18, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: This study targets non-insulin using T2DM patients with 2 or more chronic conditions. The primary eligibility criteria are as follows:
Exclusion Criteria: Individuals will be excluded if they:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03983499 | ||||
| Other Study ID Numbers ICMJE | NR014866 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Gregory Talavera, San Diego State University | ||||
| Study Sponsor ICMJE | San Diego State University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | San Diego State University | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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