AzTrials
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Chronic DiseaseLINKSNCT03787485

Linking Individual Needs to Community and Clinical Services

An observational study of Chronic Disease, run by Abby Lohr at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Disease
What is being tested?
LINKS
How many people
189 participants
Where
5 sitesUnited States
Study dates
14 Jul 2017to 30 Sep 2019
Phase
Observational
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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Participants who do not consent to participate

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Mariposa Community Health Center

    Nogales, Arizona, 85621

  • El Rio Community Health Center

    Tucson, Arizona, 85714

  • Pima County Health Department

    Tucson, Arizona, 85714

  • Sunset Community Health Center

    Yuma, Arizona, 85364

  • Yuma County Health District

    Yuma, Arizona, 85364

Other trials in United States

About this study

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 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.

Read the 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. 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 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.

Conditions
Chronic Disease
Being tested
LINKS
Keywords
Community Health Worker, Community Clinical Linkage
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LINKSBehavioural

    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.

Study groups in NCT03787485
Study groupRoleWhat they receive
LINKS ParticipantsStudy participants who took part in the LINKS intervention.
Receives: Behavioral: LINKS
Electronic Medical Record ControlsThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from past (three years to baseline) participant glycosylated hemoglobin on the A1c test reported in electronic medical record after initiation of intervention

    Glycosylated hemoglobin (mmol/mol) will be extracted from laboratory reports reported in the electronic medical record.

    Measured: July 14, 2014- June 30, 2019

  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

    Height and weight reported in the participant's electronic medical record will be combined to report BMI in kg/m^2.

    Measured: July 14, 2014- June 30, 2019

  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

    Systolic and diastolic blood pressure (mmHg) will be extracted from vitals reported in the participant's electronic medical record.

    Measured: July 14, 2014- June 30, 2019

  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

    LDL, HDL, and triglycerides (mg/dL) reported in the participant's electronic medical record will be combined to report total cholesterol (mg/dL).

    Measured: July 14, 2014- June 30, 2019

Secondary outcomes (6)

  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

    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.

    Measured: July 14, 2017-March 30, 2019

  2. Change from baseline in participant physical activity frequency in the last week on 1 question physical activity question at 3 and 6 months

    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.

    Measured: July 14, 2017-March 30, 2019

  3. Change from baseline in participant mental and physical health on Short Form 8 Health Assessment (SF8) at 3 and 6 months

    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.

    Measured: July 14, 2017-September 30, 2019

  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

    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.

    Measured: July 14, 2017-September 30, 2019

  5. Change from baseline in participant hope on the State Hope Scale (SHS) at 3 and 6 months

    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.

    Measured: July 14, 2017-September 30, 2019

  6. Change from baseline in participant depression on the Center for Epidemiologic Studies Depression Scale (CES-D-R 10) at 3 and 6 months

    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.

    Measured: July 14, 2017-September 30, 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2018
  2. Study start14 Jul 2017
  3. Primary completion30 Apr 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03787485
Sponsor's protocol ID
1612044741R001
Acronym
LINKS
Status last verified
Mar 2020
First submitted
19 Dec 2018
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lohr AM, Ingram M, Nunez AV, Reinschmidt KM, Carvajal SC. Community-Clinical Linkages With Community Health Workers in the United States: A Scoping Review. Health Promot Pract. 2018 May;19(3):349-360. doi: 10.1177/1524839918754868. Epub 2018 Jan 24.

    PubMed 29363334

  • Ingram M, Doubleday K, Bell ML, Lohr A, Murrieta L, Velasco M, Blackburn J, Sabo S, Guernsey de Zapien J, Carvajal SC. Community Health Worker Impact on Chronic Disease Outcomes Within Primary Care Examined Using Electronic Health Records. Am J Public Health. 2017 Oct;107(10):1668-1674. doi: 10.2105/AJPH.2017.303934. Epub 2017 Aug 17.

    PubMed 28817321

  • Reinschmidt KM, Ingram M, Morales S, Sabo SJ, Blackburn J, Murrieta L, David C, Carvajal SC. Documenting Community Health Worker Roles in Primary Care: Contributions to Evidence-Based Integration Into Health Care Teams, 2015. J Ambul Care Manage. 2017 Oct/Dec;40(4):305-315. doi: 10.1097/JAC.0000000000000178.

    PubMed 28350634

  • Lohr AM, Ingram M, Carvajal SC, Doubleday K, Aceves B, Espinoza C, Redondo F, Coronado G, David C, Bell ML. Protocol for LINKS (linking individual needs to community and clinical services): a prospective matched observational study of a community health worker community clinical linkage intervention on the U.S.-Mexico border. BMC Public Health. 2019 Apr 11;19(1):399. doi: 10.1186/s12889-019-6725-1.

    PubMed 30975126

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Disease, run by Abby Lohr at 5 sites 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 1 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

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). The study lists 4 primary outcomes in all. 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 NCT03787485, which also lists 4 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 26 Mar 2020.

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