Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 17 of 17

List	Outcome	Time frame	Description
Primary	Change in Percentage of Glycated Hemoglobin (HbA1c)	24 months	Change in Hemoglobin A1c measured at 24 months, compared with baseline
Secondary	Change in Systolic Blood Pressure	24 months	Changes in systolic blood pressure at 24 months, compared with baseline
Secondary	Change in Low-density Lipoprotein	24 months	Change in low density lipoprotein at 24 months, compared with baseline
Secondary	Change in Body Mass Index	24 months	change in body mass index at 24 months, compared with baseline
Secondary	Change in Primary Outpatient Services	24 months	Primary outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Specialty Outpatient Services	24 months	Specialty outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Emergency Services	24 months	Emergency encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Counseling / Behavioral Services	24 months	Counseling / behavioral encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Laboratory Services	24 months	Laboratory encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Radiology Services	24 months	Radiology encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Pharmacy Services	24 months	Pharmacy encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Inpatient Services	24 months	For inpatient services, the primary data point is the presence of a DRG code indicating the patient was hospitalized. However, we also included clinic listings for labor and delivery and for observation as inpatient utilization.
Secondary	Change in Dental Encounters	24 months	Dental encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Secondary	Change in Community Encounters	24 months	Community encounters are identified using the Resource Patient Management System (RPMS) clinic variable. Community Encounters may include public health nursing and community health representative visits; however, not all community encounters (e.g. visits by Community Health Representatives in clinics where Community Health Representatives do not document their visits on the RPMS system) may be represented in this database
Other	Patient-reported Good Health	12 months	Health status is assessed by three questions using a 5-point scale response to the General Health question from the Short Form 12 survey: "Would you say that in general your health is…" "Compared to your health a year ago, would you say your health is" and "Compared to other people your age, would you say your health is" (Excellent=5, Very Good=4, Good=3, Fair=2, Poor=1), where higher values are more favorable. Binary outcome of Good Health includes "Excellent," "Very good" and "Good" as yes, other responses as no.
Other	Patient-reported Sense of Control	12 months	Sense of control is assessed using a 4-point scale response to the question "Do you feel you are in control of your health?" (Always Never=1, Rarely=2, Sometimes=3, Almost Always=4) with a higher value representing a favorable outcome. Binary outcome derived by including "Almost Always" in "Yes" and "Always never," "Rarely" and "Sometimes" in "No"
Other	Patient-reported Ability to Cope	12 months	Coping will be assessed using a 4-point scale response to two questions "how often have you found that you couldn't cope with all the things that you had to do to?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) and "In the last month, how often have you been upset because of something that happened unexpectedly?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) with a higher value representing a favorable outcome. Binary variables derived by grouping "Always never" and "Rarely" as "Yes" and all others responses as "No"

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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