Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5UL1TR001420-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital.
The pilot will evaluate the feasibility of implementing a Short Message Service (SMS) system and Home Blood Pressure Measurements (HBPM) in the Outpatient Internal Medicine (OPD) clinic at Wake Forest Baptist Hospital. Implementing a new short text messaging service will improve the health delivery system in three ways. 1) Increasing patient engagement: SMS and HBPM require an active commitment by the patients themselves in their medical care and results in a marked improvement in the adherence to medication. High adherence to home blood pressure (BP) measurements has also been reported to improve BP control. 2) Supporting patients outside of the office visits by identifying and resolving barriers to medication adherence earlier on (i.e. if patients are unable to get their prescriptions or are having significant side effects). 3) Adopting clinical guidelines to improve BP control in a vulnerable population.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Blood Pressure Monitoring by Short Message Service (SMS) | Experimental | Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits |
|
| Usual Care Plus Standard Blood Pressure Monitoring | Active Comparator | Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS System | Other | Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Screened | during screening period, about 6 months | |
| Number of Subjects Enrolled | during baseline period, about 4 months | |
| Number of Subjects Who Refuse Participation | number of participants who refuse to participate at the time of recruitment and the reason why | baseline |
| Number of Subjects Excluded Without SMS Capability | Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability. | baseline |
| Proportion of Participants Continuing myHealth | the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention | up to 12 weeks |
| Number of Participants Who Responded to SMS With At Least One Home BP Measurement | up to 12 weeks | |
| SMS Participation | The number of patients who participate in SMS will be recorded | up to 12 weeks |
| System Usability Scale (SUS) | Participants will complete the SUS in person on an I-Pad or over the phone. The SUS yields a single score on a scale of 0-100. A SUS score above a 68 would be considered above average (better) usability. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | The number of patients who demonstrate medication compliance via SMS will be recorded. | up to 12 weeks |
| Medication Adherence Questionnaire | Score ranges from 0 to 10 with higher score denoting better medication adherence. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudia Campos, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26769741 | Background | Lauffenburger JC, Choudhry NK. Text Messaging and Patient Engagement in an Increasingly Mobile World. Circulation. 2016 Feb 9;133(6):555-6. doi: 10.1161/CIRCULATIONAHA.116.021182. Epub 2016 Jan 14. No abstract available. | |
| 33988513 | Derived | Campos CL, Jones D, Snively BM, Rocco M, Pedley C, Atwater S, Moore JB. Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 May 14;10(5):e18984. doi: 10.2196/18984. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High Blood Pressure Monitoring by Short Message Service (SMS) | Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence blood pressure control education: standard blood pressure control education given during visits |
| FG001 | Usual Care Plus Standard Blood Pressure Monitoring | Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits blood pressure control education: standard blood pressure control education given during visits |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Blood Pressure Monitoring by SMS | Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence blood pressure control education: standard blood pressure control education given during visits |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Screened | Posted | Number | participants | during screening period, about 6 months |
|
baseline through week 12
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Blood Pressure Monitoring by SMS | Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence blood pressure control education: standard blood pressure control education given during visits |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia L. Campos, MD | Wake Forest School of Medicine | ccampos@wakehealth.edu | ccampos@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2020 | Mar 28, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2020 | Jan 31, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| blood pressure control education | Behavioral | standard blood pressure control education given during visits |
|
| Week 12 |
| baseline, week 12 |
| Monitoring of SBP | Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded | baseline and 12 weeks |
| Monitoring of DBP | Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded | baseline and 12 weeks |
| Initial and Follow up BP in Office | Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded. | baseline/day 0 and 12 weeks |
| Number of Participants Considered No-Shows at Clinic Visits | No-show rate at 3 months' follow-up (f/u) clinic visits. If participants fail to come to their f/u visits within 7 days of their scheduled follow-up appointment, they will be considered as "no- shows". | week 12 |
| Coordinator Time | The time spent by the coordinator on study related patient activities will be recorded | up to 12 weeks |
| BG001 | Usual Care Plus Standard Blood Pressure Monitoring | Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits blood pressure control education: standard blood pressure control education given during visits |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Subjects Enrolled | Posted | Number | participants | during baseline period, about 4 months |
|
|
|
| Primary | Number of Subjects Who Refuse Participation | number of participants who refuse to participate at the time of recruitment and the reason why | Posted | Count of Participants | Participants | baseline |
|
|
|
| Primary | Number of Subjects Excluded Without SMS Capability | Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Primary | Proportion of Participants Continuing myHealth | the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Primary | Number of Participants Who Responded to SMS With At Least One Home BP Measurement | This was only measured in the "High Blood Pressure Monitoring by SMS" arm. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Primary | SMS Participation | The number of patients who participate in SMS will be recorded | This outcome was only measured in the "High Blood Pressure Monitoring by SMS" arm. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Primary | System Usability Scale (SUS) | Participants will complete the SUS in person on an I-Pad or over the phone. The SUS yields a single score on a scale of 0-100. A SUS score above a 68 would be considered above average (better) usability. | Only 8 people in the SMS arm completed the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| Secondary | Medication Adherence | The number of patients who demonstrate medication compliance via SMS will be recorded. | Information not obtained for this outcome measure | Posted | up to 12 weeks |
|
|
| Secondary | Medication Adherence Questionnaire | Score ranges from 0 to 10 with higher score denoting better medication adherence. | Posted | Mean | Standard Deviation | score on a scale | baseline, week 12 |
|
|
|
| Secondary | Monitoring of SBP | Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded | Only 8/12 responded with their SBP in the "High Blood Pressure Monitoring by SMS" and 10/12 responded with their SBP in the "Usual Care Plus Standard Blood Pressure Monitoring". | Posted | Mean | Standard Deviation | mmHg | baseline and 12 weeks |
|
|
|
| Secondary | Monitoring of DBP | Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded | Only 8/12 responded with their DBP in the "High Blood Pressure Monitoring by SMS" and only 10/12 responded with their DBP in the "Usual Care Plus Standard Blood Pressure Monitoring" | Posted | Mean | Standard Deviation | change in mmHg | baseline and 12 weeks |
|
|
|
| Secondary | Initial and Follow up BP in Office | Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded. | Posted | Count of Participants | Participants | baseline/day 0 and 12 weeks |
|
|
|
| Secondary | Number of Participants Considered No-Shows at Clinic Visits | No-show rate at 3 months' follow-up (f/u) clinic visits. If participants fail to come to their f/u visits within 7 days of their scheduled follow-up appointment, they will be considered as "no- shows". | Posted | Number | participants | week 12 |
|
|
|
| Secondary | Coordinator Time | The time spent by the coordinator on study related patient activities will be recorded | Measure data not collected | Posted | up to 12 weeks |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Usual Care Plus Standard Blood Pressure Monitoring | Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits blood pressure control education: standard blood pressure control education given during visits | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided