Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A532050 | Other Identifier | UW Madison | |
| Protocol Version 1/12/26 | Other Identifier | UW Madison | |
| 4R33TW011891-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. The target population is patients with hypertension in rural Guatemala. Study duration will be 12-24 months.
The investigators have developed an innovative system of care utilizing CHWs equipped with a mobile application and supported and supervised remotely by physicians. This model of care is adapted from a CHW-led diabetes program enabled by a similar CDS application which the investigators implemented in the same communities in rural Guatemala where we will carry out this proposed study. This program safely led to significant improvements in glycemic control. The mobile application is built on the widely-used CommCare platform and provides clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care.
The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician.
The Secondary Objective is to evaluate the safety, acceptability to patients, and cost of CHW-led care compared to care provided directly by a physician.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Health Worker Care | Experimental | Multimodal health systems intervention: hypertension management by trained CHWs equipped with a mobile clinical decision support (CDS) application and remote supervision and support by physicians. CHWs will meet with patients each month and, with the assistance of the CDS application, follow physician-approved and evidence-based protocols to initiate and titrate antihypertensives and medications to reduce cardiovascular risk; identify potential complications of hypertension or problems with medications; and provide lifestyle counseling. For patients with comorbid hypertension and diabetes, CHWs will also manage glycemic therapy and assess for diabetes complications with the assistance of the application. |
|
| Physician Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CommCare with Mobile Clinical Decision Support (CDS) Application | Other | For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with SBP less than 140mmHg | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) | |
| Proportion of Participants with SBP less than their personalized goal |
| Measure | Description | Time Frame |
|---|---|---|
| Participant retention at 6 and 12 months | 6 months, 12 months | |
| Proportion of possible study visits completed at 6 and 12 months | 6 months, 12 months | |
| Mean duration of study visits |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Duffy, MD | Contact | 608-354-7930 | sean.duffy@fammed.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sean Duffy, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community | Recruiting | San Lucas Tolimán | Guatemala |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016250 | Compact Disks |
| ID | Term |
|---|---|
| D014742 | Videodisc Recording |
| D016249 | Optical Storage Devices |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
Not provided
Not provided
cluster randomized, controlled, non-inferiority trial, each of 15 clusters of geographically grouped communities in the San Lucas Toliman municipality of Guatemala will be randomized to either CHW or physician care
Not provided
Not provided
Not provided
Not provided
| Remote Supervision by Physicians | Other | teleconsultation with a supervising physician |
|
| CommCare Application without CDS | Other | The physician will have received training and orientation on the same clinical protocols followed by the CHWs, as well as access to reference materials for these protocols, but the version of the CommCare application used will not provide CDS, but will serve to record and review patient data only. |
|
| Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Diastolic Blood Pressure (DBP) | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Hemoglobin A1c (HbA1c) | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Diabetes Control | Indicated by the proportion of diabetic patients with HbA1c less than 8 and the proportion of diabetic patients with HbA1c less than their personalized goal. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Weight | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Total Cholesterol | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in LDL Cholesterol | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in HDL Cholesterol | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Triglycerides | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Creatinine | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in 10 year CVD risk (per WHO risk prediction charts) | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score | The H-SCALE: Medication Adherence subscale is scored from 0-21 where higher scores indicate a more positive attitude toward adherence. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in H-SCALE: Weight Management Score | The H-SCALE: Weight Management subscale is scored from 9-45 where higher scores indicate a more positive attitude toward weight management. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in H-SCALE: Physical Exercise Score | The H-SCALE: Physical Exercise subscale is scored from 0-14 where higher scores indicate a more positive behavior toward physical exercise. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in H-SCALE: Smoking Exposure Score | The H-SCALE: Smoking Exposure subscale is scored from 0-14 where a score of 0 indicates a more positive attitude toward smoking exposure. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in H-SCALE: Alcohol Intake Score | The H-SCALE: Alcohol Intake subscale contains three questions and is scored as abstainer (does not drink) or non-adherent (reported drinking alcohol). | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in H-SCALE: Healthy Eating Plan Score | The H-SCALE: Healthy Eating Plan subscale is scored from 0-70 where higher scores indicate a more positive attitude toward healthy eating. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey | PACIC will be scored on a likert scale from 1-5 (almost never to almost always) where higher scores indicate better assessment of chronic illness care. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in global hypertension care satisfaction score | Scored from 1-5 where higher scores indicate less satisfaction with hypertension care. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in pill count adherence ratio (PCAR) | PCAR is the total number of doses dispensed less that total doses missed divided by the total doses dispensed. | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Change in self-reported adherence | Self-reported adherence is rated on a five point scale of how often patients are taking their medications as directed, from "less than half the time" to "100% of the time". | Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months) |
| Proportion of lifestyle knowledge questions answered correctly | The proportion of a set of true-false or multiple choice questions developed for this study to assess hypertension-related lifestyle knowledge answered correctly | through study completion, an average of 12 months |
| up to 24 months |
| Mean duration of physician review and care coordination time per patient encounter | up to 24 months |
| Comparison of antihypertensive medications prescribed and dosages | up to 24 months |
| Proportion of patients with an indication taking aspirin | up to 24 months |
| Proportion of patients taking two or more antihypertensives | up to 24 months |
| Estimated cost of care | up to 24 months |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |