Hypertension
Conditions
Brief summary
The purpose of this study is to work with primary care physicians and their staff, and with community health workers (CHWs) to improve diabetes and hypertension management, health behaviors and improve blood pressure for South Asian patients with uncontrolled diabetes and hypertension in primary care clinics in Atlanta, Georgia. The CHWs are community members who are trained to work with patients to address health needs holistically by providing information on wellness, nutrition, stress relief, and blood pressure management in a culturally-appropriate and language-appropriate manner.
Detailed description
The study will provide research training, technical assistance, and capacity-building to community and clinical sites in Georgia for implementation of culturally tailored, evidenced-based CHW programs to improve HTN and diabetes management for South Asians. In addition, the use a multi-theoretical framework to test the effectiveness of a CHW-led intervention compared to usual care among South Asian individuals with diabetes and uncontrolled HTN in Atlanta. The primary outcome is blood pressure control, defined as 130/80 mmHg. It is hypothesized that, compared to usual care, individuals receiving the CHW intervention will be 20% more likely to achieve blood pressure control at 6 months. And to apply RE-AIM and CFIR frameworks to delineate factors influencing appropriateness, fidelity, adoption, and maintenance of the intervention within clinical and community settings to optimize intervention replication. In addition, this study will serve as a national information and dissemination resource in the adaptation of evidence-based strategies to reduce geographic disparities in HTN and diabetes across Asian American groups.
Interventions
BEHAVIORALCHW
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
CHW intervention: Inclusion Criteria: * identified as of South Asian ethnicity * are at least 21 years of age and younger than age 80 * had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months * a diagnosis of diabetes * a diagnosis of hypertension * an uncontrolled BP reading (\>130/80mmHg) in the last 6 months Provider Surveys Inclusion criteria * clinicians employed by the clinic * have enrolled into the study. Key Informant Interviews Inclusion criteria * must be a provider, clinic manager, or community health worker. CHW intervention
Exclusion criteria
* under the age of 21 and older than 80 * pregnant * Type 1 diabetes or diabetes secondary to other conditions * malignancy or life threatening illness with life expectancy of \<5 years * inability to perform unsupervised physical activity * diagnosed cognitive deficits or limited decision-making capacity Provider Surveys Inclusion criteria * clinicians who are unable to complete the survey in the English language. Key Informant Interviews Inclusion criteria * who are unable to participate in the interview conducted in the English language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Achieve Blood Pressure (BP) Control. | Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Haemoglobin A1c (HbA1c) | 6 months | Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Systolic Blood Pressure (SBP) | Month 6 | SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Diastolic Blood Pressure (DBP) | Month 6 | DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
| Body Mass Index (BMI) | Month 6 | BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| Control Group Control participants will be offered the health education sessions as a point of service and not for research purposes | 91 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Health Issues | 1 | 0 | 0 |
| Overall Study | Ineligible post consent | 0 | 0 | 5 |
| Overall Study | Left the country | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 |
| Overall Study | No longer interested | 1 | 0 | 0 |
| Overall Study | Unable to maintain time commitment | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Community Health Workers (CHW) Treatment Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 12.5 | 56 years STANDARD_DEVIATION 11.7 | 55.8 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 183 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 92 Participants | 183 Participants | 91 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 92 participants | 183 participants | 91 participants |
| Sex: Female, Male Female | 53 Participants | 103 Participants | 50 Participants |
| Sex: Female, Male Male | 39 Participants | 80 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 91 |
| other Total, other adverse events | 0 / 92 | 0 / 91 |
| serious Total, serious adverse events | 0 / 92 | 0 / 91 |
Outcome results
Primary
Percentage of Patients Who Achieve Blood Pressure (BP) Control.
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.
Time frame: Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Community Health Workers (CHW) Treatment Group | Percentage of Patients Who Achieve Blood Pressure (BP) Control. | 40.2 percentage of participants |
| Control Group | Percentage of Patients Who Achieve Blood Pressure (BP) Control. | 24.2 percentage of participants |
Secondary
Body Mass Index (BMI)
BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community Health Workers (CHW) Treatment Group | Body Mass Index (BMI) | 26.8 kg/m2 | Standard Deviation 4.5 |
| Control Group | Body Mass Index (BMI) | 26.7 kg/m2 | Standard Deviation 4.4 |
Secondary
Change in Haemoglobin A1c (HbA1c)
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community Health Workers (CHW) Treatment Group | Change in Haemoglobin A1c (HbA1c) | 6.7 Percentage change in HbA1c | Standard Deviation 0.8 |
| Control Group | Change in Haemoglobin A1c (HbA1c) | 6.9 Percentage change in HbA1c | Standard Deviation 0.9 |
Secondary
Diastolic Blood Pressure (DBP)
DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community Health Workers (CHW) Treatment Group | Diastolic Blood Pressure (DBP) | 76.8 mmHg | Standard Deviation 9.2 |
| Control Group | Diastolic Blood Pressure (DBP) | 81.0 mmHg | Standard Deviation 7.4 |
Secondary
Systolic Blood Pressure (SBP)
SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community Health Workers (CHW) Treatment Group | Systolic Blood Pressure (SBP) | 126.1 mmHg | Standard Deviation 11.3 |
| Control Group | Systolic Blood Pressure (SBP) | 132.5 mmHg | Standard Deviation 12.4 |