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Linking Individual Needs to Community and Clinical Services (LINKS)

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ClinicalTrials.gov Identifier: NCT03787485
Recruitment Status : Active, not recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborators:
Pima County Health Department
Yuma County Health District
El Rio Community Health Center
Sunset Community Health Center
Mariposa Community Health Center
Arizona Community Health Outreach Workers Association (AzCHOW)
Information provided by (Responsible Party):
Abby Lohr, University of Arizona

Brief Summary:
For 15 years, the Centers for Disease Control and Prevention (CDC)-funded Arizona Prevention Research Center (AzPRC) has been engaged in academic community collaborative research to reduce chronic disease health disparities among the Latino border communities in Arizona, which positions the center well to contribute to CDC's current winnable battle of nutrition, physical activity and obesity. The AzPRC's proposed research study Linking Individual Needs to Community and Clinical Services (LINKS) will implement and evaluate a CHW-delivered preventive program linking primary care settings dedicated to reaching the under-served with community services that are county-delivered or -based. By developing community-clinical linkages, the AzPRC will help ensure access to, and quality of, culturally relevant prevention and promotion efforts. These efforts will result in a sustainable and scalable CHW model program that reduces obesity and associated chronic disease, and improves overall health in under-served communities at the Arizona U.S.-Mexico border.

Condition or disease Intervention/treatment
Chronic Disease Behavioral: LINKS

Detailed Description:

Over the past 15 years, CDC-funded AzPRC researchers have strengthened collaborations with community partners while developing and implementing comprehensive diabetes prevention and control programs (1998-2019), and policy intervention research (2009-2014) in Southern Arizona border communities. The community health worker (CHW)-led diabetes programs were successful in terms of community perception and health improvements.1,2,3 Despite this success, disparities in chronic disease remained unacceptably high. The investigators developed and implemented an innovative intervention research project, Acción Para La Salud (Acción), which engaged CHWs in community-level advocacy to empower border communities to address root causes of chronic disease. This community-based participatory research (CBPR) project recognized the importance of addressing the social determinants of health to overcome health disparities in chronic disease. The investigators have published results and processes of Acción.

Chronic disease and obesity health disparities continue to disproportionately affect Hispanic populations along the U.S. Mexico border in part due to barriers to healthful nutrition, adequate physical activity, and mental/emotional well-being as well as insufficient access to culturally appropriate health care services. In collaboration with our border-wide Community Action Board (CAB), the investigators are taking our intervention expertise one step further by developing and testing novel CHW-led interventions that will link community and clinical services.

In recent years, federally qualified community health centers (FQHCs), a major backbone of the primary care system in reaching under-served populations across the US, have begun to involve the CHW model into various services, often with a focus on chronic disease prevention and control. While CHWs help improve the quality and cultural relevancy of health care, improve patient centered care, and improve linkages between primary care and community services, each clinic adapts practices within their clinic environment without clear guidelines about best practices, or concrete evidence regarding activities best shown to lead to improvement in health outcomes. In addition, there may not be clear linkages from the clinic to CHW programs in the community that have been shown to be effective in chronic disease control and prevention, and there are challenges in identifying mechanisms for the sustainability of effective clinical or community programs. Our current intervention research proposes to fill these gaps by establishing clear guidance and best practices for CHW involvement in primary care and community settings to prevent and manage chronic disease, and to promote mental/emotional well-being.


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Study Type : Observational
Actual Enrollment : 214 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Linking Individual Needs to Community and Clinical Services
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LINKS Participants
Study participants who took part in the LINKS intervention.
Behavioral: LINKS
The primary aim of LINKS is to create community-clinical linkages between three community health centers and their respective county health departments in southern Arizona. This study will also develop and evaluate a chronic disease and emotional well-being intervention that will connect clinic patients to community-centered, county-delivered, community health worker programs.

Electronic Medical Record Controls
The principal analytical strategy is propensity score matching, which will lead to the generation of a natural control group from the health centers existing electronic medical records. Propensity matching is highly effective in addressing selection bias of known confounders and enables causal inferences when randomization is not possible, feasible or appropriate, by creating matched groups with similar covariate distributions. Matched controls will be extracted from the electronic medical record from the participating clinics.



Primary Outcome Measures :
  1. Change from past (three years to baseline) participant glycosylated hemoglobin on the A1c test reported in electronic medical record after initiation of intervention [ Time Frame: July 14, 2014- June 30, 2019 ]
    Glycosylated hemoglobin (mmol/mol) will be extracted from laboratory reports reported in the electronic medical record.

  2. Change from past (three years to baseline) participant body mass index (BMI) calculated from height (meters) and weight in (kilograms) reported in electronic medical record after initiation of intervention [ Time Frame: July 14, 2014- June 30, 2019 ]
    Height and weight reported in the participant's electronic medical record will be combined to report BMI in kg/m^2.

  3. Change from past (three years to baseline) participant blood pressure based on systolic and diastolic blood pressures reported in electronic medical record after initiation of intervention [ Time Frame: July 14, 2014- June 30, 2019 ]
    Systolic and diastolic blood pressure (mmHg) will be extracted from vitals reported in the participant's electronic medical record.

  4. Change from past (three years to baseline) participant total cholesterol as measured by low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides reported in electronic medical record after initiation of intervention [ Time Frame: July 14, 2014- June 30, 2019 ]
    LDL, HDL, and triglycerides (mg/dL) reported in the participant's electronic medical record will be combined to report total cholesterol (mg/dL).


Secondary Outcome Measures :
  1. Change from baseline in participant self-rated health, emotional well-being, and life satisfaction on 3 questions from the Behavioral Risk Factor Surveillance System (BRFSS) at 3 and 6 months [ Time Frame: July 14, 2017-March 30, 2019 ]

    The investigators will ask three questions from the BRFSS:

    1. Would you say in general your health is: (Excellent / Very good / Good / Fair / Poor)
    2. How often do you get the social and emotional support you need? (Always / Usually / Sometimes / Rarely / Never)
    3. In general, how satisfied are you with your life? (Very satisfied / Satisfied / Dissatisfied / Very Dissatisfied)

    Responses from the BRFSS are Likert type questions. Individual items from the scales will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale. An increase in the score demonstrates a positive outcome.


  2. Change from baseline in participant physical activity frequency in the last week on 1 question physical activity question at 3 and 6 months [ Time Frame: July 14, 2017-March 30, 2019 ]

    To determine participant physical activity, the investigators will ask a single question regarding the amount of physical activity the subject engaged in during the previous week:

    In the past week, on how many days have you done a total of 30 minutes or more of physical activity, which was enough to raise your breathing rate? (0-7 days)

    An increase in days reported demonstrates a positive outcome.


  3. Change from baseline in participant mental and physical health on Short Form 8 Health Assessment (SF8) at 3 and 6 months [ Time Frame: July 14, 2017-September 30, 2019 ]
    Responses from the SF8 are Likert type questions. Individual items from this scale will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale. An increase in the score demonstrates a positive outcome.

  4. Change from baseline in participant social support on the Social Support Inventory (Enhancing Recovery in Coronary Heart Disease, ENRICHED) (SSI) at 3 and 6 months [ Time Frame: July 14, 2017-September 30, 2019 ]
    Responses from the SSI scales are Likert type questions, with the exception of SSI question 7 (Are you currently married or living with a partner? Yes/No). Individual items from this scale will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale (excluding SSI question 7). An increase in the score demonstrates a positive outcome.

  5. Change from baseline in participant hope on the State Hope Scale (SHS) at 3 and 6 months [ Time Frame: July 14, 2017-September 30, 2019 ]
    A total score for the SHS can be obtained by adding the values of the responses to each item, yielding a score from 6 - 48. An increase in the score demonstrates a positive outcome.

  6. Change from baseline in participant depression on the Center for Epidemiologic Studies Depression Scale (CES-D-R 10) at 3 and 6 months [ Time Frame: July 14, 2017-September 30, 2019 ]

    A total score for the CES-D-R 10 scale is found by determining the sum of the items which are scored as:

    Rarely or none of the time (less than 1 day); Some or a little of the time (1 - 2 days); Occasionally or a moderate amount of time (3 - 4 days); All of the time (5 - 7 days)

    Questions 5 & 8: Rarely or none of the time (less than 1 day) = 3 to All of the time (5 - 7 days) = 0

    All other questions: Rarely or none of the time (less than 1 day) = 0 to All of the time (5 - 7 days) = 3

    An increase in the score demonstrates a positive outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All participants will be adults (21 and older), among whom approximately 70% are expected to be women, and the majority (at least 60%) to be Hispanic.
Criteria

Inclusion Criteria:

  • Participants who have pre-diabetes, glucose intolerance or diabetes, and/or hypertension, and/or high cholesterol
  • Participants not receiving palliative care;
  • Participants without a history of serious mental illness (SMI)
  • Participants who are not pregnant;
  • Participants who speak either English or Spanish;
  • Participants who are geographically close to the community based site; and
  • Participants who consent to participate in the study.

Exclusion Criteria:

  • Participants who do not consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787485


Locations
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United States, Arizona
Mariposa Community Health Center
Nogales, Arizona, United States, 85621
El Rio Community Health Center
Tucson, Arizona, United States, 85714
Pima County Health Department
Tucson, Arizona, United States, 85714
Sunset Community Health Center
Yuma, Arizona, United States, 85364
Yuma County Health District
Yuma, Arizona, United States, 85364
Sponsors and Collaborators
Abby Lohr
Pima County Health Department
Yuma County Health District
El Rio Community Health Center
Sunset Community Health Center
Mariposa Community Health Center
Arizona Community Health Outreach Workers Association (AzCHOW)
Investigators
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Principal Investigator: Scott C Carvajal, PhD, MPH University of Arizona Prevention Research Center

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abby Lohr, Senior Research Specialist, University of Arizona
ClinicalTrials.gov Identifier: NCT03787485     History of Changes
Other Study ID Numbers: 1612044741R001
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abby Lohr, University of Arizona:
Community Health Worker
Community Clinical Linkage

Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes