Type 2 DiabetesLUNA-DNCT03983499
Latinos Understanding the Need for Adherence in Diabetes
A study testing Special Intervention in people with Type 2 Diabetes and Glycemic Control, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Glycemic Control, Cardiovascular Risk Factors
- What is being tested?
- Special Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
South Bay Latino Research Center
Chula Vista, California, 91910
About this study
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.
Read the 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.
- Being tested
- Special Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Special InterventionBehavioural
Also called Medical Provider clinical visits, Behavioral Health Provider counseling visits, Care Coordination, Group Health Education
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.)
| Study group | Role | What they receive |
|---|---|---|
| Special Intervention | Experimental | 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. Receives: Behavioral: Special Intervention |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Blood Value
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).
Measured: 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).
Secondary outcomes (5)
Body Mass Index (BMI)
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).
Measured: 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).
Total Cholesterol
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).
Measured: 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).
Blood Pressure (BP)
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).
Measured: 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).
Patient Health Questionnaire (PHQ-8)
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).
Measured: 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).
Generalized Anxiety Disorder 7-item (GAD-7)
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start16 Jul 2015
- Primary completion18 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Talavera, San Diego State University
- Investigators
- Gregory A Talavera, MD/MPH, Principal investigator, SDSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983499
- Sponsor's protocol ID
- NR014866
- Acronym
- LUNA-D
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castaneda SF, Gallo LC, Garcia ML, Mendoza PM, Gutierrez AP, Lopez-Gurolla M, Roesch S, Pichardo MS, Munoz F, Talavera GA. Effectiveness of an integrated primary care intervention in improving psychosocial outcomes among Latino adults with diabetes: the LUNA-D study. Transl Behav Med. 2022 Aug 17;12(8):825-833. doi: 10.1093/tbm/ibac042.
PubMed 35776001Talavera GA, Castaneda SF, Mendoza PM, Lopez-Gurrola M, Roesch S, Pichardo MS, Garcia ML, Munoz F, Gallo LC. Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. Transl Behav Med. 2021 Sep 15;11(9):1665-1675. doi: 10.1093/tbm/ibab052.
PubMed 34057186
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latinos Understanding the Need for Adherence in Diabetes
- ClinicalTrials.gov ID
- NCT03983499
- Acronym / sponsor ID
- LUNA-D / NR014866
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Special Intervention | Experimental | Behavioral: Special InterventionThe 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Special InterventionAlso: Medical Provider clinical visits, Behavioral Health Provider counseling visits, Care Coordination, Group Health EducationThe 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.) | Behavioural | Special Intervention |
Primary outcome
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).
5 secondary outcomes
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 35776001Castaneda SF, Gallo LC, Garcia ML, Mendoza PM, Gutierrez AP, Lopez-Gurolla M, Roesch S, Pichardo MS, Munoz F, Talavera GA. Effectiveness of an integrated primary care intervention in improving psychosocial outcomes among Latino adults with diabetes: the LUNA-D study. Transl Behav Med. 2022 Aug 17;12(8):825-833. doi: 10.1093/tbm/ibac042.
- Derived from this study: PubMed 34057186Talavera GA, Castaneda SF, Mendoza PM, Lopez-Gurrola M, Roesch S, Pichardo MS, Garcia ML, Munoz F, Gallo LC. Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. Transl Behav Med. 2021 Sep 15;11(9):1665-1675. doi: 10.1093/tbm/ibab052.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Talavera, MD/MPH principal investigator
SDSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Special Intervention in people with Type 2 Diabetes and Glycemic Control, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03983499, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.