Trial Outcomes & Findings for Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States (NCT NCT04263311)

Last Updated: 2024-12-27

Results Overview

The primary outcome will be the percentage of eligible patients at a practice site to achieve BP control (130/80 mmHg) six months following the index office visit. The primary outcome will be measured by the treatment participants and providers surveys.

Recruitment status

COMPLETED

Study phase

Target enrollment

195 participants

Primary outcome timeframe

Month 6

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Community Health Workers (CHW) Treatment Group Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group Control participants will be offered the health education sessions as a point of service and not for research purposes	Non Randomized Participants who were consented but were not randomized to either group.
Overall Study STARTED	97	93	5
Overall Study COMPLETED	92	91	0
Overall Study NOT COMPLETED	5	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Community Health Workers (CHW) Treatment Group Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group Control participants will be offered the health education sessions as a point of service and not for research purposes	Non Randomized Participants who were consented but were not randomized to either group.
Overall Study Lost to Follow-up	1	2	0
Overall Study Health Issues	1	0	0
Overall Study Left the country	1	0	0
Overall Study Unable to maintain time commitment	1	0	0
Overall Study No longer interested	1	0	0
Overall Study Ineligible post consent	0	0	5

Baseline Characteristics

Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Community Health Workers (CHW) Treatment Group n=92 Participants Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group n=91 Participants Control participants will be offered the health education sessions as a point of service and not for research purposes	Total n=183 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 12.5 • n=5 Participants	55.8 years STANDARD_DEVIATION 11.0 • n=7 Participants	56 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	50 Participants n=7 Participants	103 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants n=5 Participants	91 Participants n=7 Participants	183 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	92 Participants n=5 Participants	91 Participants n=7 Participants	183 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants	91 participants n=7 Participants	183 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Outcome measures

Outcome measures
Measure	Community Health Workers (CHW) Treatment Group n=92 Participants Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group n=91 Participants Control participants will be offered the health education sessions as a point of service and not for research purposes
Percentage of Patients Who Achieve Blood Pressure (BP) Control.	40.2 percentage of participants	24.2 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: This study was launched during COVID and the study team had difficulty collecting the data from all participants due to the pandemic. Data collection from all participants was not an option due to the preference for telemedicine appointments vs in-person appointments. A1c data was collected through the electronic medical record and reported on data that was available, the remaining data is missing.

Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

Outcome measures

Outcome measures
Measure	Community Health Workers (CHW) Treatment Group n=28 Participants Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group n=19 Participants Control participants will be offered the health education sessions as a point of service and not for research purposes
Change in Haemoglobin A1c (HbA1c)	6.7 Percentage change in HbA1c Standard Deviation 0.8	6.9 Percentage change in HbA1c Standard Deviation 0.9

SECONDARY outcome

Timeframe: Month 6

SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

Outcome measures

Outcome measures
Measure	Community Health Workers (CHW) Treatment Group n=92 Participants Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group n=91 Participants Control participants will be offered the health education sessions as a point of service and not for research purposes
Systolic Blood Pressure (SBP)	126.1 mmHg Standard Deviation 11.3	132.5 mmHg Standard Deviation 12.4

SECONDARY outcome

Timeframe: Month 6

DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

Outcome measures

Outcome measures
Measure	Community Health Workers (CHW) Treatment Group n=92 Participants Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group n=91 Participants Control participants will be offered the health education sessions as a point of service and not for research purposes
Diastolic Blood Pressure (DBP)	76.8 mmHg Standard Deviation 9.2	81.0 mmHg Standard Deviation 7.4

SECONDARY outcome

Timeframe: Month 6

BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

Outcome measures

Outcome measures
Measure	Community Health Workers (CHW) Treatment Group n=92 Participants Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions. CHW: Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.	Control Group n=91 Participants Control participants will be offered the health education sessions as a point of service and not for research purposes
Body Mass Index (BMI)	26.8 kg/m2 Standard Deviation 4.5	26.7 kg/m2 Standard Deviation 4.4

Adverse Events

Community Health Workers (CHW) Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Zanowiak

NYU Langone Health

Phone: (646) 501-3502

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place